On March 30, 2022, Israel-based CartiHeal Ltd, announced FDA PMA (premarket approval) for its Agili-C implant for treating knee joint surface lesions. Five days later, April 4, Durham, Bioventus announced plans to buy CartiHeal for about $315 million.
FDA grants 510(k) clearance to Osseus Fusion System, LLC’s Pisces-SA Standalone ALIF Interbody System.
SpineUp Inc., has received FDA 510(k) Clearance for its Romero Self-Anchored Cervical Cage.
Astura Medical received FDA 510(k) Clearance for El Capitan Oblique Anterior Lumbar Interbody Fusion System.
Some spine patients need stability of their spinal column even with limited life expectancy.
Lazurite Holdings LLC claims the first and only FDA 510(k) cleared wireless camera system for arthroscopy and other minimally invasive surgery.
VySpine™, LLC’s posterior cervical thoracic system has received FDA 510(k) clearance.
Regulatory bodies like the FDA have been racing to frame up a regulatory approach to AI or machine learning.
The magical moment of harmonic convergence between CMS and FDA vanished like Cinderella’s coach at midnight.
Former FDA Commissioner Robert Califf, M.D., may soon be back at the helm of the FDA.
Recently, we reported on various guidances the FDA intends to issue…here’s the skinny.
FDA’s CDRH wants your comments on its proposed draft and final medical device guidance documents for 2022.
CMS wants to stop automatically paying for medical devices that have been designated as a “Breakthrough Device” by the FDA.
“…one of the most vexing challenges in spinal fusion procedures” has a new 510(k) cleared device.
The largest 510(k) FDA clearance in history. That’s the claim Tyber Medical, LLC makes regarding the August 13, 2021, FDA clearance of the company’s expanded line of anatomical plating systems. The expansion covers all long and short bones.
Your knee implant may “CHIRP” in the future as Zimmer Biomet utilizes Canary Medical’s proprietary implantable canturio™ te tibial extension sensor technology that, “monitors implant function to inform surgeons and patients of post-surgery progress.” Knees, hips, shoulders coming soon. Zimmer’s smart knee implant to receive FDA De Novo classification grant and authorization to market the Persona IQ, for total knee replacement surgery.
Zimmer Biomet’s ROSA® Hip System for direct anterior total hip replacement is now FDA 510(k) cleared.
Orthopaedic Implant Company receives FDA 510(k) clearance for its wrist plating technology.
Finally, FDA publishes its final guidance on unique device identifier rules.
Via Surgical received FDA 510(k) clearance for its rotator cuff repair TissueTak™ tendon anchor.
Onkos Surgical’s BioGrip® 3D-printed implant technology receives FDA 510(k) clearance.
Biorez’s BioBrace implant surgical mesh for soft tissue augmentation now FDA 510(k) cleared.
With FDA 510(k) clearance on April 1, 2021, THINK Surgical adds three more FDA cleared knee implant systems to be used with the company’s TSolution® One Total Knee Application bringing the total to EIGHT knee systems now cleared for use with THINK Surgical’s robotic assist system.
Spinal Elements, Inc.’s interbody fusion device, the Lucent 3D, has received FDA clearance.
Next Science Limited receives 510(k) clearance for its single step XPERIENCE No Rinse Antimicrobial Solution.
Ron Sacher and Premia Spine are breaking out from the crowd with the March 31, 2021 announcement that the TOPS system has received Breakthrough Device Designation from the FDA.
The FDA cleared Brainlab AG’s Loop-X Mobile Imaging Robot and the Cirq Robotic Alignment Module.
The development of the STAR Ankle promised to usher in a new era of joint replacement for the ankle. From Germany’s Waldemar Link to the V Brothers to Stryker, the ankle delivered great clinical data. Then warnings started. Read about the latest from the FDA.
SUNSET rule is a “ticking time bomb” and will tie the current administration into bureaucratic knots.
OrthoSpin’s AutoStrut G2 System 2nd generation robotic digitally enabled external fixation device FDA cleared.
We have written countless articles about the dangers and treatments of concussions on athletes and soldiers. FDA announced the authorization of Q30 Sports Science’s Q-Collar, to “aid in the protection of the brain from the effects associated with repetitive sub-concussive head impacts.”
The FDA approves HDE for Additive Orthopaedics’ talus spacer for avascular necrosis of the ankle joint.
2020, it seems, was one of the most productive and impactful years in FDA History. Novel device okays, for example, hit a record, jumping 90% YOY.
Acuitive Technologies’ novel new thermoset bioresorbable synthetic polymer receives 510(k) clearance. Citregen is a citrate-based, anti-inflammatory polymer that protects the soft tissue graft during insertion and optimize graft fixation to bone.
Are actuaries of providers and of Medicare playing “hot potato” with each other? Who wins?
NGMedical, Inc., has received its first FDA 510(k) clearance for its 3-D printed titanium cervical BEE cage.
AAOS issues new guide—“Navigating the Value-Based Care Landscape: A Musculoskeletal Guide.”
How will the FDA regulate Artificial Intelligence and Machine Learning software? This is a question critically important to device makers.
Miach Orthopaedics, Inc. receives FDA De Novo premarket review pathway for its Bridge-Enhanced ACL Repair (BEAR) Implant—the first new treatment for ACL tears in over 30 years.
Johnson & Johnson subsidiary, DePuy Ireland, receives FDA 510(k) clearance for its VELYS Robotic-Assisted Solution for total knee arthroplasty.
Medtronic receives additional FDA 510(k) clearance for its evolving Mazor Robotic Guidance system.
Carlsmed’s aprevo™️ devices receive FDA Breakthrough Device Designation AND 510(k) clearance.
icotec AG’s Vader Pedicle System and bone cements receive FDA 510(k) clearance for advanced-stage tumors.
NuVasive received FDA 510(k) clearance for multi-level use of its massive family of interbody systems.
Ossio, Inc.’s OSSIOfiber Compression Screws have received 510(k) clearance from the FDA.
SeaSpine and Implanet joint venture—Mariner Cap System and JAZZ Cap technology—are FDA 510(k) cleared.
Anika Therapeutics’ new WristMotion Total Arthroplasty System granted FDA 510(k) marketing clearance.
RTI Surgical received FDA 510(k) clearance for its Dynamic Active Compression (DAC) Plate foot system.
CartiHeal Ltd, granted “Breakthrough Device Designation” by the FDA for the company’s Agili-C Implant.
Boca Raton, Florida-based SurGenTec announced that the FDA granted 510(k) clearance for its 3D GraftRasp System.
FDA and White House clash over COVID-19 vaccines guidance and testing.
CurveBeam’s HiRise weight bearing CT imaging system for the lower extremity receives CE marking.
Bone growth stimulators and metatarsophalangeal joint prostheses reclassified by FDA Orthopaedics Panel.
Simplify Medical’s Simplify® Disc receives rare FDA premarket application approval.
NovoPedics’ MeniscoFix meniscus replacement device granted FDA Breakthrough Device Designation.
Medacta added FDA 510(k) clearance to CE Mark for its Lateralized Glenosphere shoulder implant.
SurGenTec receives FDA 510(k) clearance for OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft.
Donald Trump accused the FDA of being part of a “Deep State,” trying to deny him a second term.
Non-invasive bone growth stimulators should be marketed through 510(k) clearance per FDA proposal.
IlluminOss’ photodynamic bone stabilization system for fibula fractures receives FDA 510(k) clearance.
FDA has not shown any interest in enforcing compliance with trial registry reporting requirements.
FX Shoulder receives 510(k) clearance for new version of humeral head and glenosphere shoulder implants.
The Value in Health Care Act was introduced in Congress and supported by 13 leading healthcare stakeholders.
Orthofix’s internal deformities correction JuniOrtho Plating System for 510(k) cleared/CE Mark approved.
CoreLink’s F3D-C2 Stand-alone Cervical System receives FDA 510(k) clearance.
A consortium of AAOS members expressed “No Confidence” in the Academy regarding orthopedic diversity. What’s going on?
CE Mark received for Smith & Nephew’s Regeneten Bioinductive Implant for rotator cuff repair.
CMS suspended and is reevaluating its Advance Payment Program to Part B suppliers.
Sirakoss Ltd has received FDA 510(k) clearance for its nanosynthetic bone graft substitute, Osteo3 ZP Putty.
DePuy Synthes and NuVasive each issue spinal device warnings.
Implanet announced that it has received extended CE marking from European regulatory authorities.
Trump pulls out of W.H.O. Good idea. Maybe, maybe not. Who really cares—the docs do.
Is a battle brewing over hospital system mergers and acquisitions post COVID-19?
The FDA is still clearing medical devices. On May 1, 2020, the agency granted 510(k) clearance for Corin USA’s OPSInsight, a cloud-based software which brings the company’s Optimized Positioning System (OPS) online. According to a May 12, 2020 company announcement, the software enables surgeons to access and adjust customized pre-operative plans for total hip arthroplasty […]
As elective surgeries resume, orthopedic surgeons will have critical questions to ask and answer before going back into the operating room. The American Academy of Orthopaedic Surgeons (AAOS) recently issued a document titled: Navigating the COVID-19 Pandemic, to help surgeons answer critical questions for their patients, staff and themselves. C. Lowry Barnes, M.D., of the […]
Meet Michael Caputo. He’s the new top communications person at the Department of Health and Human Services (HHS). The Azar Watch Caputo, a former Trump campaign official, was reportedly sent over to HHS to keep an eye on current HHS Secretary Alex Azar. An April 15, 2020 POLITICO report cites two unnamed White House sources […]
Eighteen years after the first clinical trial implantation, the FDA has given its approval for a two-level indication for Centinel Spine, LLC’s prodisc® L Lumbar Total Disc Replacement (TDR) system. The prodisc first received FDA approval in 2006. In an April 4, 2020 press release, the company said they are now the only company with […]
When it comes to resuming elective surgeries, the President says he has absolute authority. Governors say they’ll decide. Whoever decides, AAOS President Joe Bosco, M.D. is pleading with Congress to make sure there is still a viable orthopedic community surviving to do the surgeries. It’s mid-April. Here’s where things stand.
American’s physicians want the government to provide each physician, nurse practitioner and physician assistants enrolled in Medicare and Medicaid with one month of pay to account for financial losses and non-reimbursable expenses due to the COVID-19 pandemic. The funds, states an April 7, 2020 letter to Secretary of Health and Human Services (HHS), Alex Azar, […]
The American Academy of Orthopaedic Surgeons (AAOS) is hosting live webinars (most recently on Thursday, April 9 at 9:00 p.m. (EDT)), to provide a COVID-19 update and enable members to ask questions. You can register for the webinar here. In addition, the Academy has developed a resource center that is specific to orthopedics. AAOS COVID-19 […]
The FDA is expediting the development of treatments for COVID-19 in a new program called the Coronavirus Treatment Acceleration Program (CTAP) and offering new guidance on conducting clinical trials of all medical products during the pandemic. Coronavirus Treatment Acceleration Program On March 31, 2020 the FDA began cutting red tape, redeploying staff and working 24 […]
Physicians who own their own practices will have unique challenges in protecting their patients, staff and their businesses. The AMA offered a 14-point financial checklist to keep your practice solvent during the pandemic. Read it here.
Centers for Medicare and Medicaid Services (CMS) wants all elective surgeries, non-essential medical, surgical, and dental procedures to be delayed during the COVID-19 pandemic. The agency issued the recommendation in a press release on March 18, 2020. The purpose of the recommendation is to preserve personal protective equipment (PPE), beds and ventilators. Delays of elective […]
Responding to requests from providers during the COVID-19 pandemic, Centers for Medicare and Medicaid Services (CMS) announced on March 22, 2020, that it was providing reporting relief for clinicians, providers, hospitals and facilities participating in quality reporting programs during the fourth quarter of 2019. Reducing Data Collection and Reporting Burden The agency stated it knows […]
As a service to all physician and front-line healthcare workers, the American Medical Association (AMA) has offered its latest, comprehensive resources of the COVID-19 pandemic to ensure access to the latest news and information. The COVID-19 physician and practice resources released by the AMA include: A Physicians Guide to COVID-19, to help physicians prepare their […]
A federal judge in New York says the Department of Health & Human Services (HHS) made a mistake back in 2007, resulting in a 10-year gap in clinical data reporting through ClinicalTrials.gov that must be made available to the public. The judge, Naomi Buchwald, said the agency “misinterpreted” a federal law requiring the agency to […]
Israeli-based OSSIO, Inc. received a new 510(k) clearance from the FDA on March 6, 2020 for the company’s Hammertoe Fixation System. It wasn’t the clearance that caught our attention as much as the length of time the FDA took to grant the clearance. The company submitted the 510(k) notification to the FDA in March 2019. […]
A father-son team, with the backing of Purdue University, say they have developed an injectable new bone healing drug which repairs bone fractures faster than current products on the market. The injectable drug, NOV004, is “unique” because it concentrates at the fracture site while reducing exposure to the rest of the body. The father is […]
The Battle of the Bulge in 1945 turned 19-year old Robert Michael Yanchus into an orthopedic surgeon and earned him a Purple Heart.
Dr. Duffner was a member of the Riverside County Medical Association, and a founding member of the North American Spine Society.
Has the FDA Orthopedic Advisory Panel outlived its usefulness? More than two years have passed since the FDA called an ortho panel meeting. Could the Ortho Advisory Panel be missing in action due to a lack of innovation? We turn to MCRA’s Glenn Stiegman for answers and a look at the state of innovation.
The FDA has 510(k) cleared the second total ankle on the market with patient CT guided technology. On January 29, 2020, after an eight-month review, the FDA cleared Memphis-based In2Bones Global, Inc.’s Quantum Total Ankle. The agency determined it was substantially equivalent to three other total ankles on the market. While substantially equivalent to competing […]
In 2017, the FDA 510(k) cleared BioElectronics Corporation’s ActiPatch, a drug-free therapy for over-the-counter (OTC) treatment of knee osteoarthritis (OA) and heel pain. On February 3, 2020, the company announced additional FDA clearance for “adjunctive treatment of musculoskeletal pain,” including pain in the back, knees, wrists, hips, elbows and ankles. In the company’s words, the […]
Bamboo as a bone substitute? It may not be as far-fetched as it sounds if you’ve ever seen bamboo grow out of control. On January 30, 2020, Italy-based GreenBone Ortho srl announced approval under the CE Mark for its GreenBone Substitute bone graft. Bone grafts can be autologous (bone harvested from the patient’s own body, […]
Playing tennis is more effective at preventing musculoskeletal (MSK) conditions than going to the gym. That’s the conclusion of a recent study (“The Musculoskeletal Health Benefits of Tennis”) published in the journal, Sports Health. “Tennis players displayed significantly greater upper body MSK function than nonplayers when cluster scores of body fat percentage, handgrip strength, and […]
The North American Spine Society (NASS) sent two spine safety alerts to its members in January 2020 about drugs and surgical gowns. The first alert on January 24, pertained to Cardinal Health notifying customers on January 16 regarding “potential quality issues affecting some the company’s Level 3 surgical gowns and accompanying PreSource procedural packs.” The […]
The FDA’s Center for Devices and Radiological Health (CDRH) announced on January 16, 2020, that it will host a public workshop on March 5 to discuss virtual and augmented reality in medicine. Virtual and augmented reality technologies are gaining use in such areas as surgical training and planning and providing surgeons with hands-free access to […]
In November 2019, Medtronic issued an urgent field safety notice regarding its O-arm O2 Imaging System. The company said there was a “potential for navigational inaccuracy” when using the system’s auto-registration feature, “when used in conjunction with an Image-Guided Surgery System, for a specific set of O-arm O2 Imaging System serial numbers.” The cause of […]
On January 6, 2020, Nextremity Solutions, Inc. announced 510(k) clearance by the FDA to market its tarsometatarsal joint (TMT) device, the InCore TMT System. It took the agency a little over three months to clear the system. The company stated the system focuses on second and third TMT fusion, more commonly known as a Lisfranc […]
If a surgeon can “see” the problem, he or she is likely to fix it. Carestream Health, Inc.’s recently FDA 510(k)-cleared DRX-Evolution Plus with Carestream Digital Tomosynthesis (DT) promises more clarity, simplified workflow and reduced exam time from standard X-rays, according to a January 14, 2020 company press release. The DT system is a digital […]
After granting approval to Flexion Therapeutics, Inc.’s Zilretta in October 2017, the FDA has now given the company permission to revise the Zilretta product label. Zilretta (triamcinolone acetonide extended-release injectable suspension) is a non-opioid drug for managing chronic osteoarthritis (OA) knee pain. The previous label said Zilretta was “not intended for repeat administration.” The new […]
Dump the paperwork! On Friday, December 13, 2019, the FDA issued a final rule to allow medical device submissions to be made to the agency in a single electronic form instead of multiple paper copy submissions. The new rules cover both the Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and […]
After two inspections in September and November, the FDA sent ConforMIS, Inc., a warning letter on December 10, 2019 concerning the number of sterilization cycle failures relating to Vaporized Hydrogen Peroxide (VHP) sterilizers that the company uses as a limited, alternative sterilization method for a small quantity of products. The letter did not question product […]
Chicago-based Augmedics Ltd, says its Xvision Spine augmented reality (AR) guidance system is the first AR guidance system to allow surgeons to visualize the 3D spinal anatomy of a patient during surgery as if it were “X-ray vision”. The “vision,” according to the company, allows the surgeon to navigate instruments and implants while looking directly […]
The FDA wants to change the way it shares information with the public about device approvals. On December 16, 2019, the agency put out a 16-page proposal to end its practice of publishing quarterly lists of approval or denial decisions for premarket approval applications (PMAs) and humanitarian device exemptions (HDEs) in the Federal Register. The […]
On December 13, 2019, the FDA granted 510(k) clearance to Medacta USA’s MyShoulder Placement Guides, a shoulder prothesis system with anatomical guides for a single patient anatomy. It took the agency almost nine month to find the device substantially equivalent to WrightTornier’s Blueprint. The clearance follows regulatory approval in Japan earlier this year. The clearance […]
A cancer doc is now FDA Commissioner. The U.S. Senate confirmed Stephen Hahn, M.D., on December 13, 2019 on a 72-18 bi-partisan vote. Hahn is a radiation oncology expert and was recently the chief medical executive of the University of Texas MD Anderson Cancer Center in Houston. He’d been a professor of radiation oncology at […]
EOS imaging SA’s EOSedge has become the first general X-ray system powered by a high-resolution photon counting detector to be 510(k)cleared by the FDA. The system is an updated version of the company’s previously cleared EOS system that used gaseous detectors. In a November 29, 2019 press release, the company said the system provides, “local […]
On the basis of a recent FDA 510(k) clearance, OrthoGrid Systems, Inc., will be adding a trauma application to its PhantomMSK image distortion correction software platform. PhantomMSK Trauma was cleared after previous clearances for company’s hip replacement and hip preservation technology in February 2019. According to the FDA clearance document, PhantomMSK Trauma is a non-invasive […]
Federal prosecutors have filed a Complaint against former MiMedx CEO, Pete Petit and two former executives of the company. The charge? They cheated in reporting revenue in SEC documents, tried to cover up the misdeeds and then lied to the accountants. An old story. Petit fires back and the company settles.
New, two-year follow-up data for i-FACTOR™ Peptide Enhanced Bone Graft shows that the one-year superiority over autologous bone grafts in anterior cervical discectomy and fusion (ACDF) procedures for degenerative cervical disc disease, is sustained for two years. So, Cerapedics, Inc. asked the FDA if they could update their package insert accordingly. The FDA agreed. On […]
NuVasive, Inc.’s CoRoent Small Interlock system can now be used for “multiple contiguous levels from C2-T1 for anterior cervical discectomy and fusion (ACDF) procedures,” after receiving 510(k) clearance from the FDA on November 13, 2019. The FDA previous cleared the system in September 2016 for only one level. The company stated in a November 21, […]
With the October 22, 2019 FDA 510(k) clearance of the company’s cemented version Madison total knee implant, Bordeaux, France-based Implanet has added a knee offering to the its flagship JAZZ spine system. Madison Knee System According to the FDA document, the Madison knee system is intended for total knee replacement. The components are for, “use […]
In October the FDA rang a warning bell about a potential nationwide shortage of critical medical devices due to state environmental protection agencies closing facilities in Illinois and Georgia that make ethylene oxide (EtO), the most used gas used to sterilize medical devices in the U.S. On November 25, 2019, the agency announced two steps […]
The FDA has cleared THINK Surgical, Inc.’s TSolution One Total Knee Application for use in total knee arthroplasty (TKA). According to the October 8, 2019 FDA clearance document, the application is compatible with the Zimmer Persona Knee System. The company previously received clearance for the system back in 2014 for total hip arthroplasty. The FDA […]
Just as Stryker Corporation was announcing the acquisition of Wright Medical and its TARS ankle system, the company warned of plastic fracture problems with its STAR (Scandinavian Total Ankle Replacement) system. Stryker issued a “Safety Communication” on October 11, warning of higher than expected risk of polyethylene fracture. Click here for the notice. The communication […]
Stryker Corporation has received 510(k) clearance for its Sahara Lateral 3D Expandable Interbody System featuring Lamellar 3D Titanium Technology. The system came to Stryker with its acquisition of K2M, Inc. First Ever 3D-Printed Lateral Expandable Device In a November 1, 2019 press release, the company stated the device is the “first ever 3D-printed lateral expandable […]
Titanium might have worked just fine when Biomet Founder Dane Miller implanted it into his own arm decades ago. But he didn’t bake into that implant the concept of immune response and, famously, had his own implant removed several weeks later. Pro Macrophage Implant On November 1, 2019, a young emerging growth company, Austin, Texas-based […]
The EPA has shut down some facilities that make ethylene oxide (EtO), the most common substance used to sterilize medical equipment. Hold on, warns the FDA and device makers. Reducing the availability of EtO could result in shortage of critical medical devices. Where is this going?
The FDA has cleared Viseon, Inc.’s imaging device which, according to the company, integrates minimally invasive surgical procedures with high-definition imaging technology. The company explains the novelty of its Voyant System in a September 19, 2019 press release, “as an alternative to surgical microscopes, endoscopes and loupes, designed for use in both posterior and lateral-access […]
The FDA has issued a Final Guidance on the Humanitarian Device Exemption (HDE) program. The September 6, 2019 guidance reflects changes required by the 21st Century Cures Act and further explains the criteria to determine “probable benefit” related to agency’s decision-making process for humanitarian use devices (HUD). HUDs are medical devices that treat no more […]
Misgav, Israel-based OrthoSpin Ltd. has won FDA 510(k) clearance for AutoStrut, its automatically adjusted robot-assisted external ring fixation system for orthopedic treatments. The use of external fixation, according to the company, is a common treatment option for orthopedic-related problems such as bone lengthening, setting complex fractures, and correcting deformities. But there are challenges with that […]
Trauma fixation device maker, CurvaFix, Inc. received 510(k) clearance from the FDA back in March for its CurvaFix Intramedullary Rodscrew System. On September 26, 2019, the company announced the completion of the first surgical procedure using the system to repair a pelvic fracture. Follows Natural Bone Shape The company announcement stated the rodscrew, “is the […]
CoreLink, LLC, announced 510(k) FDA clearance on September 24, 2019 for its Oro™ Lateral Plate System. The company says the system is “the only lateral plating system on the market with the flexibility to be used as supplemental fixation in multiple scenarios, including optional permanent connection to CoreLink F3D or CL5 Lateral interbody devices.” Indications […]
The FDA issued an “Urgent Safety Communication” on October 1, 2019 regarding cybersecurity vulnerabilities that “may introduce risks for certain medical devices and hospital networks.” While stating it was unaware of any confirmed adverse events related to these vulnerabilities, the agency noted software already exists to exploit those vulnerabilities. Read details here.
The FDA wants to be crystal clear about how it will regulate medical device software that help doctors make decisions about patient care. Device software functions may include “Software as a Medical Device (SaMD)” and “Software in a Medical Device (SiMD).” The 21st Century Cures Act removed certain software functions from the definition of a […]
Non-spinal metallic bone screws and washers and, spinal plating systems have been identified in draft guidances by the FDA as two of four devices to qualify for the agency’s expedited Safety and Performance Based Pathway for medical devices program. That means makers of these devices, if they chose to participate in the program, will no […]
A few days ago, Richard Kaul, M.D. informed us that the U.S. Supreme Court has docketed for consideration his writ of mandamus in the matter of Richard Arjun Kaul v Christopher J. Christie (16-CV-02364). Kaul wants “$28,000 trillion” in financial damages resulting from what he calls the “illegal revocation” of his medical license by the […]
Active Implants, LLC has received Breakthrough Device Designation from the FDA for its meniscus replacement device. In a September 19, 2019 press release, the company said the designation will allow for an expedited review of the NUsurface Meniscus Implant and, if eventually approved, make it the first artificial meniscus in the U.S. The FDA program […]
The FDA just approved the first ever Investigational New Drug (IND) application to evaluate a drug/biologic combination product for lumbar interbody fusion of the spine. On September 3, 2019, Swiss-based Kuros Biosciences AG, announced the FDA approval its IND application to initiate a Phase 2a clinical trial to “evaluate the use of Fibrin-PTH (KUR-113) in […]
Finding a long-term solution that provides pain relief AND preserves the motion of the foot has been a challenge for orthopedic surgeons treating patients with metatarsal joint pain. The August 14, 2019 FDA 510(k) clearance of Arthrosurface, Inc.’s Boss Toe Fixation System may offer hope to those surgeons. Non-Fusion Option “Finally, there is an option […]
The FDA has 510(k) cleared a new bone graft substitute from Irvine, California-based Biogennix LLC. The product, Morpheus-C, was designed, according to the company, “to address surgeon demand for a collagen-enhanced product. With [Morpheus-C, rebranded as Agilon], Biogennix introduces the addition of purely-sourced, type-1 bovine collagen, for optimal material handling properties, among other potential benefits.” […]
Dallas-based 4WEB Medical’s cervical fusion device for the treatment of degenerative disc disease (DDD) was 510(k) cleared by the FDA on August 12, 2019. It took the agency a little over four months to clear the device. The Cervical Spine Truss System – Stand Alone (CSTS-SA) Interbody Fusion device is for use at one level […]
Misgav, Israel-based ApiFix Ltd. has received FDA Humanitarian Device Exemption (HDE) approval for the company’s Minimally Invasive Deformity Correction (MID-C) System for the treatment of progressive adolescent idiopathic scoliosis (AIS). The company says the system retains spine flexibility, “all via a less invasive surgical procedure compared to spinal fusion. Patient recovery is relatively pain-free and […]
Pat Miles’ arc of history of the last 20 years in spine is unrivaled. And he just added to the record as a Delaware judge ruled on June 7, 2019, that Miles did not violate his non-compete agreement with NuVasive, Inc., his former company. Miles started out at Medtronic Sofamor Danek. Then, along with former […]
FDA has approved Rinvoq (upadacitinib), a 15 mg, once-daily oral Janus kinase (JAK) inhibitor, for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate (MTX-IR). RA Affects 1.3 Million Americans RA is a huge orthopedic issue affecting 1.3 million Americans. The autoimmune […]
The FDA has approved the first spinal tether device intended to be used in children and adolescents, who have not responded to conservative treatment options, such as external bracing, to correct idiopathic scoliosis. Idiopathic scoliosis is a sideways curvature of the spine. It is the most common spinal deformity in children and is most often […]
On August 2, 2019, the FDA announced the approval of Tokyo-based Daiichi Sankyo’s “Turalio (pexidartinib) capsules for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT),” a cancer of the joint synovium, “associated with severe morbidity or functional limitations and not responsive to improvement with surgery.” “Today’s approval is the first FDA-approved […]
FDA user fees are going up overall by about 6% for the next year. But there’s good news. Fees are only going up 2.7% for premarket applications (PMAs). On July 31, 2019, the agency announced the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2020. The new fees apply […]
On August 2, 2019, Lyon, France-based Medicrea Group announced FDA 510(k) clearance for its Tulip Genesis, a top loading screw system. The screw is a subset of the company’s PASS LP system, which was cleared back in May. The Tulip clearance, according to the announcement, “completes” the company’s UNid ASI (Adaptive Spine Intelligence) proprietary platform […]
Swiss-based SpineWelding AG now has FDA 510(k) clearance to sell its “bone welding” Elaris Pedicle Screw System in the U.S. According to the August 2, 2019 FDA clearance document, the thoracolumbosacral pedicle screw system is intended to “provide immobilization and stabilization of spinal segments through posterior, non-cervical, pedicle fixation.” Bone Welding Using its patented BoneWelding […]
nView medical Inc., a Salt Lake City early stage start-up, has received 510(k) clearance from the FDA for its interventional fluoroscopic X-ray system called the nView s1. In a July 13, 2019 press release, the company said its technology integrates, “the latest developments in low-dose X-ray imaging with intelligent imaging algorithms to provide fluoroscopic and […]
Keeping your medical devices in compliance with European regulators after May 2020 is going to require a massive effort. The EU is repealing its existing regulatory scheme and replacing it with one that is not yet fully devised. Confused? We talked to the experts.
Just a month after announcing FDA 510(k) clearance of its PROLIFT® Lateral Expandable Spacer System, on July 25, 2019, Illinois-based Life Spine, Inc. announced clearance for additional widths of the system. The new 8mm-10mm cleared widths, according to the company, will more than double the current footprint options to accommodate a wider range of patients. […]
In 2016, the FDA issued a final rule on postmarket reporting for combination drugs. Orthopedic combination products include implants with growth factors and antibiotic loaded bone cements. The rule seemed to create more questions and concerns than answers, so on July 22, 2019, the agency issued a 44-page final guidance explaining how to comply with […]
The FDA has 510(k) cleared the Atlanta, Georgia-based MiRus, LLC’s GALILEO™ Spine Alignment Monitoring System. The monitoring system provides real-time measurement and monitoring of segmental and/or global spine alignment without repeated imaging. Company VP Angad Singh, said in a July 22, 2019 press release that this was the first and only FDA-cleared product that “intraoperatively […]
Add low-level, non-opioid laser treatment to the toolbox for treating lower back pain. On June 1, 2019, after less than three months of review, the FDA granted 510(k) clearance to Melbourne, Florida-based Erchonia Corporation’s FX-635 laser system for the “adjunctive use in providing temporary relief of nociceptive musculoskeletal pain.” The predicate devices were all previously […]
Swiss-based icotec AG’s Carbon/PEEK minimally invasive and open spine pedicle systems have been granted FDA 510(k) clearance. According to FDA documents, the systems, called VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0, are intended to “restore the integrity of the spinal column even in the absence of fusion for a limited time period in […]
On July 12, 2019, Berlin-based aap Implantate AG announced FDA 510(k) clearance of the company’s LOQTEQ VA foot plates 2.5. Altogether, the clearance is for 12 plates and 4 cortical screws. According to the company, the system enables flexible treatment of fractures as well as correction of malpositions in the fore- and midfoot area. In […]
It’s been more than a year and a half since the FDA’s Orthopaedic and Rehabilitation Devices Panel met. That was the panel meeting to consider the premarket approval application (PMA) for the Barricaid Annular Closure Device by Intrinsic Therapeutics. The device was approved. There are no ortho panel meetings scheduled for the rest of 2019. […]
The FDA has 510(k)-cleared Benvenue Medical, Inc.’s enhanced Luna® XD MIS expandable interbody device. Luna XD is a multi-expandable interbody fusion device. It took the agency almost six months to clear the device. Called the Luna 3D GEN2 Interbody Fusion System in the FDA clearance documents, the system consists of the Luna 3D Implant and […]
An exclusive report by Charles Piller on July 2, 2019 in Science (“Exclusive: FDA enforcement actions plummet under Trump”), reveals that FDA enforcement actions began to decline under the Obama Administration and are plummeting under the Trump Administration. For example, the agency’s warning letters have fallen by one-third over a comparable period from the previous […]
Artificial Intelligence and Machine Learning are transforming orthopedic medical devices. How is the FDA thinking about regulating the software that impacts the safety profile of devices implanted in patients? It’s early in the game. But the times they are a-changin’.
Salt Lake City, Utah-based Innovasis, Inc. has received FDA 510(k) clearance for its next-generation intervertebral body fusion system. On June 25, 2019, the company announced that the FDA had cleared its LxHA™ Lateral Interbody Fusion Device, which according to FDA documents, “is intended to stabilize a spinal segment to promote fusion using bone graft, in […]
On Friday, June 21, 2019, Jeff Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health (CDRH), made good on former FDA Commissioner Scott Gottlieb, M.D.’s promise to release more than 20 years of non-public reports of adverse events involving medical devices. The agency thus ended the Alternative Summary Reporting (ASR) Program and […]
Add another expandable spacer to spine surgeons’ armamentarium with the FDA’s 510(k) clearance of Life Spine, Inc’s PROLIFT® Lateral Expandable Spacer System. The June 18, 2019 announcement by the company stated that the agency took about two months to clear the system. In a summary document submitted to the FDA, the company says the system […]
After almost three years of FDA review, DT MedTech, LLC has won FDA premarket approval (PMA) for its Hintermann Series H3 total ankle replacement system. PMAs are a big deal. No 510(k)-clearance tinkering at the edges to get a device to market in the cheapest, quickest way possible. The company submitted its application in August […]
Misonix, Inc. calls its newly FDA 510(k) cleared neXus® Ultrasonic Surgical Aspirator System a “revolutionary” and “transformational” product. For the first time, the Nexus platform integrates the company’s three handheld BoneScalpel, SonicOne and Sonastar devices into one platform. According to the company, BoneScalpel is “a precision, oscillating tool designed for millimeter-wide cuts in bone while […]
The FDA has cleared Tenex Health, Inc.’s, TX-Bone, an ultrasonic surgical instrument that fragments, emulsifies and aspirates soft and hard tissue. The minimally invasive technology, according to a May 13, 2019 company announcement, is specifically designed to “treat chronic pain in soft and hard tissue…and allow physicians to identify and simultaneously perform selective cutting and […]
“Detecting spine fractures is difficult due to the variability by which they present,” says Michael Braginsky, co-founder and CTO of Israeli-based Aidoc Medical, Ltd. The incidence of delayed or missed diagnosis of cervical spinal fractures (CSFs) has reportedly been found at between 5 and 20%. First AI System Flags Suspect CT Images of the Spine […]
Zavation Medical Products, LLC, an employee-owned medical device company in Flowood, Mississippi, has a new FDA 510(k) clearance for its pedicle screw system. According to the FDA filing, the system is comprised of polyaxial pedicle screws, rods, and cross connectors. The system can be used for “single or multiple level fixations. The pedicle screws are […]
Beam me up Scotty. Osama Choudhry, M.D., a neurosurgeon and CEO of Medivis says the surgical world continues to primarily rely on two-dimensional imaging technology “to understand and operate on incredibly complex patient pathology.” He adds, “Holographic visualization is the final frontier of surgical imaging and navigation.” The FDA is now on board by giving […]
Knoxville, Tennessee-based ChoiceSpine LLC, has been given 510(k) clearance by the FDA to market its Tiger Shark C interbody device and the Boomerang Anterior Cervical Plate for use together or separately in cervical spinal fusion procedures. The company says the Boomerang is a “single-step screw blocking mechanism for fast insertion and fixation to the anterior […]
It’s going to get more expensive for medical device companies to navigate through Health Canada’s regulatory agency starting on April 1, 2020. No joke. On May 16, 2019, the agency said device sponsors for Class II, III and IV medical device registrants will have to pay 75% of costs for pre-market evaluations, 67% of right […]
Exposure to radiation during fluoroscopically guided procedures is of grave concern to patients and providers. Imagine reducing that exposure by 89%. On May 22, 2019, ControlRad, Inc., announced FDA 510(k) clearance of its ControlRad Trace. The company says its device “is the only technology that can be integrated into existing mobile C-arms to reduce radiation […]
The FDA has approved a diagnostic tool to help determine whether swelling around a joint replacement is being caused by an infection. And hence, whether or not to proceed with a revision surgery. Synovasure Lateral Flow Test Kit On May 23, 2019, the FDA gave permission to Zimmer Biomet Holdings, Inc., to market its Synovasure […]
The FDA has granted 510(k) clearance to Treace Medical Concepts, Inc., to expand indications for its Lapiplasty 3D Bunion Correction System to treat young patients over 12 years of age. Intended Use According to FDA documents, the system is intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small […]
The FDA has cleared AMDT Holdings, Inc.’s hexapod fixator device and an associated version of its deformity analysis and correction software. SixFix Hexapod Fixator and Deformity Analysis and Correction Software (DACS) is a multilateral circular external fixation system. The FDA summary document states the system includes rings, footplates, arches, struts, threaded rods, wires, external fixation […]
After almost eight months of review, the FDA has granted Collagen Matrix, Inc., 510(k) clearance of its Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix putty through its spine business unit. Bone Mineral, Bioactive Glass and Collagen The OssiMend Bioactive Moldable Bone Graft Matrix, according to FDA documents, is “…composed of anorganic bone mineral, bioactive […]
Artoss, Inc. has received clearance from the FDA to add a posterolateral fusion indication and an alternate applicator to its previously cleared NanoBone bone graft substitute. On April 23, 2019, after a three-month review, the agency granted clearance to the company’s NanoBone SBX Putty for standalone use in posterolateral spinal fusion. Indications According to FDA […]
Silicon Valley-based SI-BONE, Inc. has received additional FDA 510(k) clearance “for use of its iFuse Bedrock technology in fusion of the sacroiliac (SI) joint during long construct procedures.” The iFuse Implant System, available since 2009, had been cleared in November 2018 for sacroiliac fusion using a dorsal, or posterior, implantation approach to treat SI joint […]
What began in 2004 as a promising business idea of a laserscopic spinal surgical center between a couple of surgeons and two businesspeople, turned into a vicious and nasty fight between partners. The court documents tell the sordid details of the collapse of the Laser Spine Institute. Read here.
Looks like outgoing FDA Commissioner Scott Gottlieb, M.D. wants to leave behind a giant data dump. A recent Kaiser Health News (KHN) investigation revealed a hidden FDA reporting pathway used by device makers to report allegedly millions of injuries and malfunctions for about 100 medical devices. Gottlieb is promising to release those reports. In a […]
Between 2007 and 2017, there was a 243% increase in the annual number of foreign device inspections and a 46% increase in domestic inspections, reports the FDA Center for Devices and Radiological Health (CDRH). Therefore, on March 29, 2019, the agency issued a draft guidance to implement uniform processes and standards for those inspections. In […]
The FDA has granted 510(k) clearance to Scientific Analytics Inc.’s markerless DARI Health System. The company claims the system, “Is the world’s first and only technology that delivers validated 3D kinematic and kinetic motion analytics without sensors, markers, or force plates. And it produces the reports within minutes of capturing the data.” The system, according […]
The FDA has granted the first clearance for a pedicle screw system using a new superalloy metal. On March 27, 2019, MiRus, LLC, announced that it had received a 510(k) clearance for its Europa Pedicle Screw System. The system uses a proprietary molybdenum rhenium superalloy instead of titanium, cobalt or iron-based alloys currently in use. […]
Akron, Ohio-based Intellirod Spine says it has received a “first-ever” FDA De Novo Approval for its disposable spinal rod strain sensor, the LOADPRO. According to the FDA, the De Novo process provides a pathway to Class I or Class II classification for medical devices for which general controls or general and special controls “provide a […]
Bob Brosnahan, COO of Additive Implants, Inc., says failure to achieve sagittal alignment due to hardware design limitations still exists in ACDF (anterior cervical discectomy and fusion) procedures. The company’s recently FDA 510(k) cleared SureMAX Cervical Spacer “was engineered with that stability in mind,” added Brosnahan. The company submitted its clearance notification on September 10, […]
AAOS elects the Chief of Orthopedic Oncology at Perelman School of Medicine as its new President. Leading a 39,000-member organization into a future of robotics, treatment algorithms and ever shifting regulatory and reimbursement rules is no mean feat. Dr. Weber presented her vision and plan at the just concluded Academy annual meeting. Here it is.
Scott Gottlieb, M.D, is leaving his job as FDA Commissioner. He has been one of the most effective political appointees of the Trump Administration and set in motion significant reforms and changes at the agency. Some loved him. Some not so much. So, what happens next?
SIG Medical Inc.’s AdvantageRib System was granted 510(k) clearance by the FDA on February 14, 2019. The system is intended to be used by physicians for the fixation, stabilization, and fusion of rib fractures and osteotomies of normal and osteoporotic bone. According to the FDA summary document, the system consists of bridges (with locking posts) […]
When the FDA’s Ortho Panel voted against recommending approval for Intrinsic Therapeutics’ anular closure device, the company barely kept a pulse. But through patient engagement with FDA staff and unassailable evidence, the company persisted and eventually won FDA approval. A lot of lessons here.
AdvaMed, the medical device industry’s largest trade group, has updated its Code of Ethics governing industry interactions with medical providers. It’s the first update in a decade. What’s changed? For one thing it is more user friendly. Here’s what we found.
The FDA has given Zimmer Biomet Holdings, Inc., 510(k) clearance for the company’s ROSA robotically assisted total knee replacement surgery platform. This follows the clearance for the ROSA Surgical Device in 2010 when French-based MedTech SA owned the technology. That was followed in 2015 with the clearance of ROSA Brain and 2016 for ROSA Spine. […]
In the middle of the U.S. China tariff fight, the Chinese government has decided to shift its regulatory philosophy from “stringent” pre-approval to “rigorous” post-approval and increased scrutiny of U.S. based medical device companies. Should you be worried? Here are the details.
When the FDA approves or clears a device, the FDA blessing is specific to a manufacturing site. What constitutes a manufacturing site change and when should you submit a premarket approval application (PMA) supplement for a site change? What documentation should you should submit in a site change supplement? Three years ago, the agency issued […]
On January 16, 2019, by a vote of 18-1, the FDA’s bone, reproductive and urologic drugs advisory committee (BRUDAC) recommended that the FDA approve Amgen and UCB (Euronext Brussels)’s Evenity (romosozumab) osteoporosis treatment. The lone dissent came from the committee’s patient representative. It was the second review for the companies and came after the agency […]
It’s now the longest partial FDA and government shutdown in history. As we write these words, the agency has about three weeks of funding left to review new drug applications. For the devices, the cash flow burn rate of user fees already collected gives the agency about three months of funding to review and process […]
The FDA has granted 510(k) clearance to Israeli-based Ossio’s Ltd.’s bio-integrative material indicated “for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodesis, and bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).” The cleared OSSIO Pin Product Family, according to FDA documents, “is a fixation device made […]
What FDA changes are in store for orthopedic companies in 2019? Long-time regulatory attorney Mark DuVal provides his predictions and he definitely sees a change coming in the 510(k) clearance process. Forewarned is forearmed. Here are the details of what is likely to be a very eventful regulatory year in 2019.
The FDA has approved an Investigational Device Exemption (IDE) application for Swedish-based Episurf Medical’s Episealer personalized knee implant. The approval will allow the company to begin a clinical study and is the first step towards a Premarket Approval (PMA) application for eventual market approval. According to the company, the 180 patient study will be a […]
The science and business of treating patients with musculoskeletal diseases and trauma has its own inherent drama. But readers in 2018 gravitated to stories that spoke of stability. Here are the most widely read orthopedic stories of 2018. Relax. Have a cup of tea. It’s a good time to be part of this extraordinary community.
On December 4, 2018, Nexxt Spine, LLC, announced that the FDA 510(k) had cleared and therefore allowed full commercial launch of its Saxxony Posterior Cervical Thoracic System. The system, according to FDA documents, is intended to “immobilize and stabilize cervical (C1 to C7) and thoracic (T1 to T3) spinal segments as an adjunct to fusion […]
NuVasive, Inc.’s Monolith corpectomy system, which was originally cleared for commercial sale by the FDA in 2015 for thoracolumbar procedures, can now be used for cervical procedures. On November 30, 2018, the FDA granted NuVasive 510(k) clearance for expanded use of the Monolith corpectomy system after almost nine months of review. A corpectomy procedure removes […]
After a nine-month review, the FDA 510(k) cleared United Orthopedic Corporation’s vitamin E highly cross-linked polyethylene (E-XPE) hip liner. The company made the announcement on November 27, 2018. Components of the device include the U-Motion II E-XPE Cup Liner and E-XPE Cemented Cup. According to FDA documents, the device is intended for reduction or relief […]
On November 2, 2018, the FDA and Department of Defense (DoD) announced a Memorandum of Understanding (MOU) to accelerate regulatory assessment of medical products for military personnel. Hippocrates is often quoted as saying that “war is the only proper school for a surgeon.” It is not surprising then that medical advancements often come from the battlefield. […]
The Office of Inspector General (OIG) at the Department of Health and Human Services says the FDA is not sufficiently outlining how it will respond to cybersecurity risks for medical devices in the postmarket phase. This conclusion came after the OIG conducted an audit of the agency’s policies and procedures and issued a report on […]
The FDA cleared NuVasive, Inc.’s use of its Cohere Porous PEEK implant in extreme lateral interbody fusion (XLIF) surgical spine procedures. The October 5, 2018, clearance came less than three months after the company submitted its request. Indications According to the FDA’s clearance documents, the Cohere Thoracolumbar Interbody System is indicated for intervertebral body fusion […]
On November 5, 2018, the FDA issued a 10-page guidance document which says the agency “does not intend to enforce the direct mark requirements” of the unique device identification (UDI) rule for Class III medical devices that are non-sterile until September 22, 2022. The agency will delay enforcement for Class III (life-supporting or life-sustaining) devices […]
Siemens Healthineers’ Cios Spin Mobile 3D C-Arm for orthopedic, trauma and spine surgery has been cleared by the FDA for sale in the U.S. The Cios, according to FDA documents, is a mobile X-ray system designed, “to provide X-ray imaging of the anatomical structures of patients during clinical application. Clinical applications may include but are […]
Holland, Michigan-based Shoulder Innovations, LLC has announced that the FDA granted the company a 510(k) clearance for its InSet Humeral Short Stem System for shoulder arthroplasty. The system was cleared on October 23, 2018, after an almost 10-month review by the agency. Indications Use/Indications According to FDA documents, “The…system is intended for use as an […]
Innovasive, Inc., a privately held spinal device company founded in 2017 in Mission Viejo, California, has announced that the FDA has cleared the company’s DualX TLIF, LLIF and PLIF intervertebral body fusion devices. Indications According to the FDA documents, DualX is “indicated for intervertebral body fusion of the lumbar spine, from L2 to S1,” and, […]
Cork, Ireland-based OrthoXel’s new femoral nailing system has been cleared by the FDA for sale in the U.S., according to a September 26, 2018 announcement by the company. The company says its Apex Femoral Nailing System, features a “modern anatomic nail curvature in a universal nail that can be surgically implanted from antegrade or retrograde […]
In pediatrics, smaller is usually better, especially when it comes to treating complex scoliosis cases. On October 19, 2018, OrthoPediatrics Corp. of Warsaw, Indiana, announced FDA clearance for the Response 4.5/5.0mm spine system for younger patients with a smaller stature. It is the company’s 26th surgical system. The FDA determined the system was substantial equivalent […]
A lot has happened at NuVasive since Lukianov, Valentine and Miles left the company. On October 19, 2018, the company announced the hiring of Medtronic’s Chris Barry to take over as CEO. Who is this guy and what’s happening to the company? We have the history and analysis.
Are your patients taking too many oral opioids? Medtronic plc says it has an app for that. On October 12, 2018, the FDA approved the company’s new SynchroMed II myPTM Personal Therapy Manager for patients with chronic pain. The company said the device “enables patients to alleviate their unpredictable pain by delivering on-demand boluses, or […]
When is a detailed benefit-risk analysis required by the FDA to determine if a device is substantially equivalent to a legally marketed predicate device? To determine whether a new medical device is substantially equivalent, the FDA looks at intended use and technological differences which may impact safety or effectiveness. If there are technological differences, the […]
Strike two for Stryker Corporation. While not admitting any wrongdoing, the Michigan-based company has agreed to pay $7.8 million to settle charges that it violated the Foreign Corrupt Practices Act (FCPA) in India, China and Kuwait. This is the second time the company has settled allegations of violating the FCPA. This time, according to a […]
What guidance can you expect from the FDA’s Center for Devices and Radiological Health (CDRH) for 2019? Risk-benefit determinations, unique device identification and 510(k) program expansions, to name a few. And now, they want to hear from you. On October 5, 2018, the agency published three lists of guidance documents we can expect to see […]
Baxter International Inc.’s Altapore bone graft can now be used in spinal fusion. The product had previously been cleared by the FDA for use in procedures in the extremities and pelvis. Just a few weeks ago Baxter announced FDA clearance for its Actifuse Flow bone graft for use in a variety of orthopedic surgeries in […]
The FDA says medical devices are at risk for cybersecurity threats. On October 1, 2018, the agency announced that it’s going to significantly update cybersecurity guidance for medical devices, noting the threat of cyberattacks “is no longer theoretical.” “As the number of cyber attacks has increased, we’ve heard concerns about the potential for cyber criminals […]
CarboFix Orthopedics, Ltd., based in Herzeliya, Israel, has received FDA clearance to use its CarboClear Carbon Fiber Transverse Connectors with the company’s recently cleared CarboClear Pedicle Screw System. In an October 3, 2018 press release, Carl Lauryssen, M.D., director of neurosurgery at St. David’s Round Rock Medical Center, Texas, one of the first users of […]
It’s not often that we see a new total hip system cleared by the FDA. But on September 21, 2018, Cedar Knolls, New Jersey-based, b-ONE Ortho Corp. reported that the FDA granted 510(k) clearance for the company’s cementless total hip system after a ten-month review. “The b-ONE is a cementless total hip system which features […]
After a two-year engagement period, Medtronic and Mazor Robotics have agreed to a wedding. The biggest player in spine is going all-in for robotics. This puts Medtronic out front, but there is a hungry pack on their heels. Read about the deal and competition here.
ConforMIS, Inc. just announced that Smith & Nephew has agreed to pay $10.5 million to settle and enter a limited cross-license agreement over a patent dispute. In a statement issued on September 17, 2018, ConforMIS announced the settlement to put an end to numerous intellectual property battles between the two companies in the federal courts […]
Stryker Corporation saw the light—cool light—and is acquiring San Francisco-based Invuity, Inc., for $190 million in cash. Invuity announced on September 11, 2018 that its Board of Directors agreed to the buyout due to Stryker’s leadership in minimal access surgery which will, “facilitate better patient outcomes and operating room efficiencies in womens’ health, general surgery, […]
After three and half months of review, the FDA cleared Genesys Spine’s AIS-C Stand-Alone System on August 29, 2018. The company said the cervical intervertebral body fusion device, “is a first of its kind, non-screw based, zero-profile, direct-anterior stand-alone interbody system for the cervical spine.” In a September 10, 2018 press release, J. Landon Gilkey, […]
A private equity firm just paid an undisclosed sum to acquire OrthoBethesda, a private orthopedic practice. Non-physician ownership of medical practices is illegal in most states and acquisition and ownership structure challenges are tricky. We dig into the trends and pitfalls.
The FDA granted 510(k) clearance to another Baxter Healthcare Corporation bone graft substitute, Actifuse Flow, on August 17, 2018, three months after receiving the clearance request from the company. Robert Norton, M.D., an orthopedic surgeon in Boca Raton, Florida, said the bone graft substitute “has been demonstrated in preclinical models to show greater new normalized […]
On September 5, 2018, Jupiter, Florida-based Captiva Spine, Inc. announced FDA 510(k) clearance of its TirboLOX-L 3D Printed Titanium Lumbar Cages. The FDA cleared the device within four months of submission. The company incorporated its proprietary Pivotec technology into the cages. The technology has been used in thousands of surgeries, according to the company. The […]
The FDA took just two months to clear the only percutaneous PNS (Peripheral Nerve Stimulation) system allowed for sale in the U.S., according to an August 16, 2018 press release from Cleveland, Ohio-based SPR Therapeutics, Inc. The Sprint endura (single lead) and extensa (dual lead) Peripheral Nerve Stimulation (PNS) systems are non-opioid therapies indicated “…for […]
The FDA wants device makers to invite the agency’s premarket review staff into their facilities to learn about industry practices. The agency promises these formal training visits are not intended for agency staff to inspect, assess, judge, or perform a regulatory function such as compliance inspection. Experiential Learning Program (ELP) In 2017, the FDA’s Center […]
The FDA wants to have a regulatory meeting with the leaders of Zimmer Biomet Holdings, Inc. about the company’s Warsaw North Campus quality remediation problems. On August 27, 2018, Zimmer Biomet filed a Form 8-K with the SEC disclosing that the company received a Warning Letter in August 24, 2018 from the FDA related to […]
A federal jury in Green Bay, Wisconsin, nicked DePuy Synthes for $8.2 million after finding the company willfully infringed on the patent of an Acantha LLC orthopedic implant. The jury deliberated for five hours after a seven-day trial and reached a unanimous decision, according to an August 23, 2018 announcement by attorneys for Acantha. Acantha’s […]
Indiana-based Nanovis claims its nanotube surface is the “only nanotechnology in the spine market with which scientists can customize and control the spacing of the nanofeatures.” The claim comes with the August 21, 2018 announcement of the completion of a $5.5 million round of investment from Indiana venture capitalists. They will use the funds to […]
On July 27, 2018, CoreLink, LLC’s 3D Foundation anterior lumbar (ALIF) interbody device was cleared for sale in the U.S. by the FDA. Jay Bartling, the CEO of the St. Louis-based company said CoreLink now has the largest ALIF cage footprint on the market, “which will allow surgeons to maximize endplate contact area and hold […]
Sweden-based BoneSupport AB is getting ready to gather data to support a premarket approval application (PMA) to the FDA for the company’s Cerament G bone graft substitute. On August 17, 2018, the company took a step along that process by announcing that Health Canada granted approval for the product. The product already has CE Mark, […]
PEEKplus has arrived. The FDA granted Vallum Corporation a 510(k) clearance for its proprietary and patented Accelerated Neutral Atom Beam (ANAB) technology for creating nanotextured surfaces on a PEEK (polyetheretherketone) interbody device. It took the FDA a little over six months to make their decision. The company claims it is the “first and only” FDA-cleared […]
San Diego, California-based KFx Medical, LLC, holder of patents used in knotless double row rotator cuff repair, is alleging that Stryker’s product infringed on its intellectual property. In 2015, the company successfully defended these patents against Arthrex, Inc. Arthrex and KFx had fought over the Knotless Double Row Fixation patents all the way to the […]
Is this the beginning of the end of payments from Medicare for some spine surgeries in ambulatory surgical centers (ASCs)? The agency wants to know what you think. On July 27, 2018, Medicare announced the agency is reviewing whether seniors should have spine surgery at same-day surgical centers. The agency said it will examine whether […]
In June 2018, Smith & Nephew issued a Field Safety Notice warning that its first-generation Journey BSC knee system has a higher than expected risk of revision due to early femoral and tibial insert component loosening. Component loosening was identified a main cause of device failure. The company said as part of its post-market surveillance […]
The FDA just granted Wright Medical Group N.V. premarket approval (PMA) for its Augment Injectable Bone Graft which features a recombinant human platelet derived growth factor (rhPDGF). The company originally received PMA approval for the bone graft in 2015 after a torturous route through the approval process. More on that later. This injectable version of […]
Abs of steel are fine. But tight calf muscles will subject you to all manner of foot pain. Patrick DeHeer, DPM, a podiatrist from Westfield, Indiana, learned this the hard way as he suffered from posterior tibial tendonitis after taking up running. His pain was related to a condition called, Equinus, or tightness of the […]
The FDA has been looking for ways to include “real world” data in its “methodological repertoire” to clinical studies for some time. On July 18, 2018, the agency issued guidance which, it hopes, will facilitate the use of electronic health record (EHR) data in clinical investigations. The idea is to integrate routine care data clinical […]
After almost a billion dollars in fraudulent spine surgery billings, $40 million in illegal kickbacks and nine convictions for fraud, the IRS appears to be about to close the books on this criminal enterprise. At the end of the day, it’s the bean counters that bring down the Hammer.
On July 2, 2018, after a two-week trial and two-and-a-half hours of deliberation, a jury in Michigan awarded $135 million to the family of a 10-year-old girl who was left paralyzed after a 2011 spine surgery to treat her scoliosis. According to Geoffrey Fieger, the attorney for Faith DeGrand, this is the largest single medical […]
K2M Group Holdings, Inc. has received FDA 510(k) clearance and a CE Mark for its Cayman United Plate System following completion of its first surgical cases. In a July 17, 2018 announcement, the company stated the system was designed for rigid fixation to K2M’s Cascadia Lateral 3D Interbody System featuring Lamellar 3D Titanium Technology, “the […]
For 20 years, the federal government has been giving the medical community a place to develop, store and share clinical guidelines. As private payers gathered up more data with advanced algorithms to make determinations in delivering care, the medical community needed all the help it could get. But the Trump administration has decided to get […]
Acron Medical, LLC says it has “the new gold standard for a safe & stable thoracolumbar interbody fusion” after receiving FDA 510(k) clearance for its Acron PEEK TLIF (transforaminal lumbar interbody fusion) Interbody system. Christian Schawrda, the company’s co-founder and CEO said on July 16, 2018, that the engineering behind the development of the cage […]
Medtronic plc wants a better understanding of how bundled payments work at ambulatory surgery centers (ASCs). In recent years the company has started providing services to health care providers in the hospital setting. To gain that ASC understanding, the company invested in a company, spun off from Twin Cities Orthopedics (TCO), called Revo Health, LLC. […]
Johnny Benjamin, M.D., Florida’s “Breaking Bad” spine surgeon is going to prison for the rest of his life. On July 6, 2018, District Judge William P. Dimitrouleas laid down the life sentence and said he hoped the sentence would deter other professionals with money problems from being tempted into drug-dealing. Benjamin’s sentencing came after being […]
On June 25, 2018 Zimmer Biomet Holdings, Inc. responded to findings of an FDA Form 483 report after an April agency inspection of its troubled Warsaw, Indiana North Campus plant. FDA inspectors reportedly believed certain sterilization and other processes were inadequate. However, the company said the processes were up to federal standards and that the […]
There’s another sacroiliac joint (SIJ) fusion system available in the U.S. market after the FDA granted 510(k) clearance to Tenon Medical, Inc.’s Catamaran fixation system. In a June 20, 2018 press release, the company stated that their system is the first patented single implant sacroiliac joint fixation system using a “true” posterior approach for minimal […]
Medtronic plc has received a second FDA 510(k) clearance to use its Kyphon HV-R bone cement in the sacral vertebral body using sacral vertebroplasty or sacroplasty. The first clearance of the cement was for use in treating vertebral compression fractures. According to FDA filings, the cement is indicated for the treatment of pathological fractures of […]
OrthoSensor, Inc.’s Verasense sensor-assisted technology knee device is now cleared to be used with Zimmer Biomet’s Persona Knee System for total knee replacement. The technology provides a means to dynamically balance the knee during primary or revision total knee arthroplasty (TKA) intra-operatively. The device was originally 510(k) cleared in 2014, with an updated use statement […]
The new “Right To Try” legislation signed into law by the President on May 30, 2018, will generally impact orthopedic providers if they have patients who have been diagnosed with a life-threatening disease or condition, have exhausted all approved treatment options, must be unable to participate in a clinical trial involving the investigational drug, and […]
According to a June 8, 2018 posting in the Federal Register, the FDA has decided to classify in vivo cured intramedullary fixation rods as class II (special controls) devices through the de novo process. The devices will be identified as a “prescription implanted device consisting of a balloon that is inserted into the medullary canal […]
Information device makers share with payors can potentially run afoul of FDA guidelines. To clarify what an appropriate communication between device makers and payors look like, the FDA issued a final guidance on June 12, 2018 outlining how companies can share information with payers about medical devices and drugs that have not yet been approved […]
Spineology Inc. has received permission from the FDA to market its Rampart One Standard ALIF (anterior lumbar interbody fusion) device for use with or without supplemental fixation. Company CEO John Booth announced the FDA 510(k) clearance on June 4, 2018, stating, “Following the success of our beta launch, this stand-alone clearance will provide additional momentum […]
Nearly ten million active duty and retired military members and their families now have access to Aesculap Implant Systems, LLC’s lumbar total disc replacement (TDR), the activL Artificial Disc. On June 4, 2018, three years after FDA approval, the company announced that TRICARE now covers the disc for those individuals in need of lumbar TDR […]
Camber Spine Technologies has won FDA 510(k) clearance for its second device in the company’s ENZA-line of implants. On June 4, 2018, the Wayne, Pennsylvania, spine company announced the clearance of its ENZA-A Titanium Anterior Lumbar Interbody Fusion (ALIF) system, “a unique, minimally invasive interbody fusion device providing integrated fixation.” Company CEO Daniel Pontecorvo said […]
On May 22, 2018, Stryker Orthopedics issued a Product Safety Notification related to the company’s LFIT Anatomic CoCr V40 Femoral Heads. The company said it received “a higher than expected number” of complaints documenting femoral head/hip stem dissociation for certain sizes of LFIT heads manufactured prior to March 4, 2011. The company added that with […]
Michael Frey, M.D., a former partner at Advanced Pain Management & Spine Specialists in Fort Myers, Florida, pleaded guilty on May 18, 2018, to taking more than $470,000 in kickbacks for prescribing certain durable medical equipment and pain medications between 2010 and 2016. According to court documents, Frey paid medical supplier A&G Spinal Solutions $50,000 […]
On June 4, 2018, Astura Medical of Carlsbad, California, announced the FDA 510(k) clearances of the company’s cervical and lumbar interbody spacers. ALTA Cervical Spacer The first, the ALTA ACDF (anterior cervical discectomy and fusion) spacer is, according to FDA documents, “…intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration […]
A very tragic and strange story crossed our desks last week. In Cayce, South Carolina a 46-year old orthopedic surgeon has been accused of fatally shooting William Holland, a sales rep employed by CrossLink Orthopaedics, one of Stryker’s largest distributors. According to the police initially, this was a tragic, horrible gun accident. In their first […]
The FDA has 510(k) cleared Xtant Medical Holdings, Inc.’s InTice-C Porous Titanium Cervical Interbody System. The system uses the company’s OsteoSync Ti titanium scaffold material. The company says the material more closely resembles the bioscaffold of cancellous bone and combines its hardware and biologic portfolios. InTice-C is also cleared for use with the company’s proprietary […]
On May 17, 2018, we reported that a federal judge in New Jersey awarded Zimmer Biomet Holdings, Inc. $13.3 million in attorneys’ fees and another $500,000 in costs after a ten-year patent battle with Stryker Corp.’s Howmedica Osteonics Corp. The award also resulted in the invalidation of four of Howmedica’s patents. Turns out there was […]
It took the FDA about six weeks to give Providence Medical Technology, Inc., clearance to expand indications for its DTRAX spinal system for use in posterior cervical fusion in patients with cervical degenerative disc disease. Previously, the device was only broadly indicated for access and preparation of a spinal joint to aid in fusion. Providence […]
More than a decade ago, Stryker Corp.’s Howmedica Osteonics Corp. sued and accused then Zimmer Holdings, Inc. of infringing on several polymer-patents. On May 15, 2018, a federal judge in New Jersey awarded Zimmer Biomet Holdings, Inc. $13.3 million in attorneys’ fees and another $500,000 in costs. According to court documents reported by Law360, the […]
On May 10, 2018, the FDA 510(k) cleared OrthoPediatrics Corp.’s PediNail Intramedullary Nail for kids. According to the company, it is the company’s 25th surgical system. The company stated the system utilizes, “high precision, innovative, and best-in-class instruments to accompany two distinct pediatric-specific nail offerings. The platform is an unparalleled upgrade to the legacy system […]
CMS (Centers for Medicare and Medicaid Services) has issued its Proposed Rule for the Fiscal Year 2019 Inpatient Prospective Payment System (IPPS). This is the amount of money the government intends to pay for medical services starting October 2018 for operating and capital-related costs of acute care hospitals. It looks like artificial disc replacements are […]
Durable medical equipment (DME), such as pain management devices, boots and braces, can play an important part in the orthopedic surgeon’s toolbox to get patients back to their normal activities. That’s why it was good news when CMS (Centers for Medicare and Medicaid Services) announced on May 9, 2018 that the agency was issuing an […]
The FDA has cleared Nextremity Solutions, Inc.’s InCore Lapidus System to fuse the first tarsometatarsal (TMT) joint. It took the agency about three months to decide that the system was substantially equivalent to a previously approved device. The company called the system a “precision-guided, stable, intra-osseous solution for fusion of the first TMT joint.” The […]
“Breaking Bad” spine surgeon Johnny Clyde Benjamin, M.D., is going to spend a minimum of 20 years behind bars after being convicted over the 2016 fentanyl overdose death of his patient, Margaret “Maggie” Crowley. He was convicted April 27, 2018 by a federal jury in Fort Lauderdale of conspiracy to possess with intent to distribute […]
The FDA has granted its first Pre-Market Supplemental Approval (PMA) for a disposable spinal instrument set. That’s the news on May 2, 2018 out of Paradigm Spine, LLC, about the company’s coflex Interlaminar Stabilization disposable instrument kit. coflex Interlaminar Stabilization is Paradigm’s signature product and the “exclusive posterior lumbar motion preservation solution with proven long-term […]
The FDA has given Medtronic plc approval to use the company’s Infuse bone graft with two additional implants. The approval is for spine implants made of polyetheretherketone (PEEK) in oblique lateral interbody fusion (OLIF 25 and OLIF 51) and anterior lumbar interbody fusion (ALIF) procedures at a single level. The company stated in an April […]
A California appellate court has reversed a $9 million damage award against Zimmer Biomet Holdings, Inc. over the Durom Cup hip implant and granted the company a new trial to determine new, if any, damages. The court did not grant the company a new trial over liability, however. Plaintiff Lawyer’s Loose Lips The April 27, […]
Former ortho surgeon Spyros Panos, got the book thrown at him in 2013 for healthcare fraud and was sent to prison. But that, says the government, didn’t stop him from continuing his fraudulent ways. Now he is being accused of stealing another surgeon’s credentials to do Workers Comp work.
Arthrosurface, Inc.’s stemless total shoulder system has been 510(k) cleared by the FDA. The OVOMotion Shoulder Arthroplasty System took over four and a half months to get through the regulatory process, according to FDA documents. Anthony Miniaci, M.D. said in an April 18, 2018 press release that the system “truly is a revolutionary” stemless total […]
It took the FDA about 30 days to clear Ceterix Orthopaedics, Inc.’s next-generation meniscal repair system. Meniscus surgery is one the most common arthroscopic procedures in the U.S., with roughly one million performed annually. Meniscal tears are most often treated via a meniscectomy where a surgeon removes the torn tissue. NovoStitch Pro Meniscal Repair System […]
The FDA gave 510(k) clearance to Zimmer Biomet Holdings, Inc.’s Persona Trabecular Metal (TM) Tibia in January 2018. CE Mark approval came in April 2018. On March 20, 2018, the first surgical case utilizing the device was performed by Richard Moore, M.D., of Boise, Idaho. On April 16, 2018, Zimmer Biomet’s Joint Reconstruction head, Dan […]
Dallas, Texas-based CTL Medical Corporation has secured FDA 510(k) clearance to market its SEURAT Universal Pedicle Screw System. A March 29, 2018 company press release said this is the second FDA clearance for the company in the first quarter of 2018. CTL Medical’s in-house research and development team designed the new system after working closely […]
Orthopedic surgeon, Valentin Antoci, M.D, has had his license to perform surgical procedures reinstated in the State of Washington after a hearing determined he was not an immediate threat or danger to patients. On March 5, 2018, Washington’s Medical Quality Assurance Commission barred him from performing surgical procedures until a full hearing could be held. […]
Daniel Lawrynowicz, a former Stryker Corporation engineering director, pled guilty on April 3, 2018 to accepting a $75,000 bribe for steering business to a New York metallurgy firm. According to the Department of Justice (DoJ), Lawrynowicz, 48, pleaded guilty before U.S. District Judge Madeline Cox Arleo in Newark federal court to an information charging him […]
After practically accusing KFx Medical Corp. of being a patent troll, Wright Medical Technology and KFx have set aside their patent litigation over rotator cuff repair patents and agreed to a licensing deal. Wright Medical will have the right to promote the use of products and techniques for knotless double row rotator cuff repair for […]
Warrington, Pennsylvania-based CurveBeam LLC has won CE Mark approval for its LineUP and InReach orthopedic extremity computed tomography scanning systems. In an April 5, 2018 press release, the company said the compact systems provide radiology and orthopedic specialists with three-dimensional bone detail of the orthopedic extremities. “The systems can be plugged into a standard wall […]
The FDA has given Pacira Pharmaceutical Inc. permission to add a new indication for Exparel (bupivacaine Liposome injectable suspension) for use as an interscalene brachial plexus nerve block to produce post-surgical regional analgesia following shoulder surgery in adults to its label. Shoulder Surgery Indication The agency said on April 6, 2018 that the indication is […]
AGC Chemicals Americas, Inc. says it has a “safer, highly effective and environmentally friendly” fluorinated precision cleaning alternative for medical device manufacturers. According to a March 26, 2018 company announcement, the solvent called Amolea AT2, is an alternative to n-propyl and trichloroethylene solvents currently used by manufacturers. The Exton, Pennsylvania-based company claims the solvent “has […]
In early March, Orthofix International N.V. announced the 38th FDA Supplemental Approval for its next-generation Physio-Stim bone growth stimulator. The FDA granted the original Approval for the device in 1986. Approval Order Statement The Approval Order Statement, according to the FDA, is “for updates to the STIM onTrack mobile application for compatibility with Android OS. […]
DePuy Orthopaedics, Inc. wants the U.S. Supreme Court to decide whether or not statistical evidence is enough to have a device maker found guilty of violating the False Claims Act (FCA). Every device maker should be paying attention. False Claims Act Generally speaking, the FCA says you are guilty of making a “False Claim” if […]
The FDA used to be able to send its lawyers from the Department of Justice (DOJ) to threaten medical device manufacturers (among others) with civil penalties if the agency’s guidance documents weren’t being followed. But now the lawyers at DOJ are saying, not so fast, guidance documents are not binding documents and can’t take the […]
The disintermediators of Silicon Valley continue their incursion into health care. Get ready to learn two new names, Taha and Babak. On Friday March 16, 2018, CNBC reported that Amazon hired Taha Kass-Hout, M.D., MS, in the company’s “secret” health care division, named “1492.” That’s the year the New World was disrupted. FDA Big Data […]
Gainesville, Florida-based Exactech, Inc. has received 510(k) clearance from the FDA for a stemless shoulder, which Buddy Savoie, III, M.D. of Tulane University, says is different from others on the market due to the combination of three-dimensional porous material and bone cage technology. The Equinoxe Stemless Shoulder is, according to a March 12, 2018 company […]
The FDA just cleared Orthopedic Designs North America, Inc.’s humeral nail in under 30 days. The agency received the clearance request on January 26, 2018 and notified the company on February 22, 2018. According to the FDA filings, “the Talon DistalFix Humeral Nail system is indicated to aid in the alignment and stabilization of humeral […]
The FDA 3D-printed interbody fusion cage clearances keep coming. On March 7, 2018, Stryker Spine announced its Tritanium TL Curved Posterior Lumbar Cage received 510(k) clearance from the FDA. The cage is intended for use as an aid in lumbar fixation. The company says the cage is a hollow implant consisting of a “unique configuration […]
San Jose-based Panther Orthopedics, Inc.’s, flexible extremity joint fixation device has been cleared by the FDA for sale in the U.S. The Puma System is indicated for syndesmosis fixation, hallux valgus reconstruction, and tarsometatarsal fixation. While the FDA action is a clearance, meaning the device was essentially equivalent to a previously approved device, the company […]
The FDA is proposing that medical device makers be allowed to voluntarily submit summary malfunction reports for certain devices and malfunctions. According to the FDA, the proposed voluntary program “reflects goals for streamlining malfunction reporting outlined in the commitment letter agreed to by FDA and industry and submitted to Congress, as referenced in the Medical […]
The FDA has cleared Myoscience, Inc.’s latest tip to allow surgeons using the company’s iovera° targeted cold therapy platform to access nerves in the shoulder, hip, and knees. The company’s CEO, Cary Vance, said on March 5, 2018, the expanded 510(k) clearance for the Smart Tip with Nerve Stim, expands their technology in “existing call […]
San Francisco Bay area Simplify Medical Ltd, maker of the Simplify cervical artificial disc, has received its 50th U.S. patent for its cervical motion preservation intellectual property (IP) portfolio. The ‘945 Patent According to a February 27, 2018 company press release, U.S. Patent No. 9,883,945, is entitled “Artificial Intervertebral Disc with Lower Height” and relates […]
Have you ever been in an Apple store and wondered what the patient experience would be like in an Apple health clinic? Apple employees and their families are about to find out as Apple is opening its own health clinics. The clinics, called AC Wellness, will open this spring in Santa Clara County, California. A […]
The FDA has published a final rule clarifying which data the agency will accept from clinical data about medical devices collected outside the U.S. (OUS). The final rule, published February 21, 2018, “mostly affect the requirements for clinical investigations conducted OUS. As noted in FDA’s guidance, these amendments appear to be, in part, the result […]
Johnson & Johnson’s DePuy ortho business has been hit by lawsuits over two of its metal-on-metal hip systems. The company’s ATTUNE knee replacement system is at the heart of a new lawsuit after evidence of device failure due to the debonding of the tibial baseplate. Here’s a look at the legal arguments and possible market implications.
Distal extremity device maker Centric Medical has a new FDA 510(k) clearance for its foot and ankle plating system. The company, a division of Life Spine, Inc., announced on January 23, 2018, that the FDA clearance offers “multiple surgical solutions” by the company to be used in foot and ankle reconstruction procedures. “The Centric Medical […]
Last August 24, 2017, Amazon announced it was buying Whole Foods. On January 30, 2018, Amazon announced a partnership with JP Morgan and Warren Buffet to begin supplying healthcare services to one million employees. Then, February 13, 2018, The Wall Street Journal reported that Amazon is attempting to become a major hospital supplier. Is Amazon […]
The feds accused Pine Creek Medical Center LLC, a physician-owned hospital in Dallas, Texas, of paying physicians kickbacks in the form of marketing services in exchange for surgical referrals. According to a December Department of Justice press release, the hospital agreed to pay the feds $7.5 million to resolve claims that the hospital violated the […]
Just say no…. Purdue Pharma LP, the maker of OxyContin, said on February 10, 2018 that it would stop promoting opioids to doctors. But not before giving $4.15 million to 12 advocacy groups from 2012 to 2017, according to a U.S. Senate report released by Democratic Senator Clair McCaskill of Missouri. The groups include patient […]
The FDA has given 510(k) clearance for an expandable spacer system made by Orthofix International N.V. The clearance of the FORZA XP Expandable Spacer System was announced by the company on February 6, 2018. At the same time, the company announced the limited market launch of the system for the U.S. The company said the […]
DJO Global Inc., has agreed to pay $7.62 million to the feds to resolve allegations that its subsidiary, Empi Inc. (Empi), submitted false claims to TRICARE for “excessive, unnecessary transcutaneous electrical nerve stimulation (TENS) electrodes that TRICARE beneficiaries did not need or use.” TRICARE is the military’s health insurance arm. The U.S. Department of Justice […]
With some disagreement, Hippocrates is often credited with saying that, “He who desires to practice surgery must go to war.” As such, military needs for medical technology is special and unique. The Pentagon and the FDA haven’t always been on the same page when it comes to meeting the military’s needs and the FDA’s caution. […]
Irish-based and founded ortho trauma company, OrthoXel DAC, says it has an intramedullary nailing system that has “the greatest range of locking options of any intramedullary nail on the market.” The company made that bold claim in a January 16, 2018 company press release announcing the notification of U.S. FDA 510(k) clearance and European CE […]
You are a physician being asked to provide a treatment or a procedure for a patient which you believe violates your conscience. Where does a physician’s or healthcare worker’s religious freedoms under the First Amendment and a patient/citizen’s rights to equal protection and access to the law begin and end? On January 18, 2018 the […]
The FDA is looking for a few good device companies to help the agency identify manufacturing process gaps that could lead, in their words, to safer and higher quality devices while reducing the regulatory burden on manufacturers. In December, the agency’s Center for Devices and Radiological Health (CDRH) released details on its upcoming voluntary medical […]
The FDA has approved a Medtronic plc intrathecal delivery method of medications that may reduce or entirely eliminate the need for systemic opioids. SynchroMedII Intrathecal Drug Delivery System That’s the news on January 10, 2018 as the company announced the FDA approval of the new clinician programmer for use with the SynchroMedII Intrathecal Drug Delivery […]
In possible good news for interventional pain physicians, the FDA has granted Semnur Pharmaceuticals, Inc., Fast Track Designation for the company’s SP-102 product for patients with lumbar radicular pain/sciatica. On January 7, 2018, the company also announced the start of a pivotal Phase 3 clinical trial in the U.S. to evaluate the product. Click here […]
IlluminOss Medical, Inc. has received FDA De Novo clearance for its bone stabilization system. This is a big deal. The company says this is the first time the FDA’s orthopedic branch has granted such a clearance since the Food and Drug Administration Safety and Innovation Act (FDASIA) was amended in 2012 to allow a sponsor […]
On January 3, 2018, four of the top medical device industry association in the world announced they’ve revised their code of ethics to remove direct sponsorships for healthcare professionals’ attendance at medical conferences and other third-party educational events. A joint statement by heads of the groups noted the revision of codes of ethics in China […]
Zimmer Biomet Holdings, Inc. receives a lot of FDA clearances each year. The company does not usually issue press releases for each clearance. But on January 3, 2018, the new CEO of the company, Bryan Hanson, announced the FDA 510(k) clearance of the Sidus Stem-Free Shoulder system. The system is a total shoulder arthroplasty solution […]
Back in November, Medovex Corporation announced the submission of an Investigational Device Exemption (IDE) request to the FDA, for the DenerveX System, a non-addictive, non-opioid drug alternative, “designed for enduring relief of Facet Joint Syndrome related to chronic back pain.” On December 29, 2017, after conversations with the FDA, the company announced it was voluntarily […]
After a two-year suspension, the dreaded 2.3% excise tax on medical device manufacturers returned on January 1, 2018. The tax was originally imposed in 2013 as one of several taxes and fees in the Affordable Care Act (ACA) that pays for expanded health insurance. The device industry association, AdvaMed, has been fighting the tax tooth […]
Centers for Medicare and Medicaid Services (CMS) has approved the American Association of Orthopaedic Executives (AAOE) as a Qualified Clinical Data Registry (QCDR). This is a big deal because the registry allows providers to collect the data needed to participate in the Merit-Based Incentive Payment System (MIPS) coming in 2019, and qualify for higher payments. […]
At the end of 2017, Anika Therapeutics, Inc. announced FDA 510(k) clearance of its injectable hyaluronic acid (HA) based bone void filler. Hyaluronic acid is a component of synovial fluid that acts as a joint lubricant during shear stress and a shock absorber during compressive stress. According to the company’s December 27, 2017 announcement, the […]
Our uniquely dynamic and impactful industry treated more patients in 2017 than ever before and did so with a new generation of technologies and clinical skill levels. The top orthopedic stories reflected those trends while also addressing key issues like the opioid crisis, corporate disruption, and an increasingly complicated and intrusive U.S. regulatory and payment system.
The Pakistan Medical & Dental Council (Council) has initiated action against Atiq Durrani, M.D., the Pakistani spine surgeon facing allegations of medical malpractice and False Claims in Ohio in the U.S. Disciplinary Action In response, the hospital where the fugitive surgeon had been operating, suspended his privileges. On December 21, 2017, DAWN, Pakistan’s oldest and […]
Sales force and technology poaching allegations aren’t just for the likes of the orthopedics giants like Stryker Corporation and Zimmer Biomet, Inc. anymore. The smaller players are also getting into the action. On November 8, 2017, France’s Medicrea Group filed a lawsuit against K2M Spine, Inc. and several other defendants over alleged misappropriation of Medicrea’s […]
Maura Healey, the Attorney General (AG) of Massachusetts, said on December 13, 2017 that Medtronic plc has agreed to pay $12 million to resolve claims that the company used deceptive marketing practices to promote Infuse Bone Graft in spinal surgery. The settlement resolves an investigation by the AG’s office and four other states. According to […]
Imagine being a young engineer just a couple years or so out of college and having two spine industry giants go into federal court over your services. That’s what has happened to Madeline Davis as Globus Medical, Inc. and Stryker Corporation are going to federal court over Stryker’s hiring of Davis. Globus sued Stryker and […]
Lawyers representing patients suing Johnson & Johnson’s DePuy Orthopaedics, Inc. over the company’s Pinnacle metal-on-metal hip implant, thought they might have caught the company tampering with a surgeon who was a witness in a trial completed last month in Dallas. We reported at the time that a federal jury in Dallas ordered the company to […]
Omnia Medical, located in Morgantown, West Virginia, claims a first. On December 7, 2017, the company announced its vertebral body replacement (VBR) system is the first FDA 510(k) cleared system to use Invibio Biomaterial Solutions’ PEEK-OPTIMA™ HA (hydroxyapatite) Enhanced polymer “for use in the thoracolumbar spine to replace a collapsed, damaged, or unstable vertebral body.” […]
Following FDA 510(k) clearance in August of its Spira Open Matrix ALIF device for use in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1, Camber Spine Technologies, LLP, announced clearance of its Spira-C Open Matrix Cervical Interbody device on December 7, 2017. “The Spira-C,” according to the […]
Stryker Corporation and Zimmer Biomet Holdings, Inc. have been engaged in a sales rep poaching lawsuit in Texas for almost a year. Shortly after Thanksgiving the companies agreed to settle the dispute. Stryker sued Zimmer Biomet last March in Southern Texas, alleging “concerted and deliberate unfair competition, improper use of Stryker’s confidential and trade secret […]
Nevro Corp announced two European CE mark approvals in the month of November for expanded imaging labeling of the company’s Senza Spinal Cord Stimulation (SCS) system. The first mark announced on November 15, 2017, was for the company’s full-body magnetic resonance imaging (MRI) conditional labeling on the Senza SCS system delivering HF10 Therapy. The second, […]
Medovex Corporation is hoping to start a U.S. clinical trial in the near future for its DenerveX System. According to a November 27, 2017 company statement announcing the submission of an Investigational Device Exemption (IDE) request to the FDA, the system is a non-addictive, non-opioid drug alternative, “designed for enduring relief of Facet Joint Syndrome […]
Parsippany, New Jersey-based Extremity Medical, LLC’s Omni MTP Fusion System has been cleared for sale in the U.S. by the FDA. The FDA took just a little over three months to clear the device. The company’s Chairman and CEO is Matt Lyons, one of the founders of Blackstone Medical, Inc. in 1996. Lyons cofounded Extremity […]
On November 2, 2017, the Centers for Medicare and Medicaid Services (CMS) released the Medicare Physician Fee Schedule Final Rule for 2018. The final rule updates payment policies, payment rates, and other provisions for services furnished under the Medicare Physician Fee Schedule (PFS) on or after January 1, 2018. Electronic Health Records and Quality Measures […]
First, Donald Trump hired a device guy, (orthopedic surgeon and former Congressman Tom Price, M.D.) as Secretary of Health and Human Service to convince Congress to replace and repeal Obamacare. Price failed and was shown the door. Now, Trump has picked Alex Azar, a drug guy, as the new HHS Secretary to lower drug prices. […]
After winning the first trial over its Pinnacle metal-on-metal (MoM) hip implant, Johnson & Johnson’s DePuy Orthopaedics Inc. has now lost three in a row. On November 16, 2017, a federal jury in Dallas ordered the company to pay $247 million to six patients who said they were injured by the implants. This was the […]
MedShape, Inc.’s DynaNail XL TTC Fusion System has received FDA 510(k) clearance for patient use in the U.S. The additional clearance expands the product’s use to patients with longer tibial anatomies or who have undergone prior failed fusion procedures using an intramedullary nail (IM), according to a November 14, 2017 company press release. The new […]
On October 27, 2017, the Trump Administration proposed new health insurance regulations that could affect basic benefits required by the Affordable Care Act (ACA). Almost immediately, the nation’s largest society of physicians said it opposes any weakening or removal of any of the ten categories of essential health benefits (EHBs) required by the ACA. After […]
Ankle repair start-up company Mortise Medical announced FDA 510(k) clearance of its SyndesMetrics Syndesmosis repair system on November 14, 2014. The Logan, Utah-based company stated the system was developed to address three clinical needs for syndesmotic disruption injuries: predictable and repeatable anatomic reduction, restoration of physiological motion, and restoration of ankle stability. According to the […]
Medacta International’s 3DMetal Tibial Cones for knee revision surgery are now cleared for use in U.S. patients. On November 3, 2017, in addition to announcing the FDA 510(k) clearance, the company also announced that Kevin Hardt, M.D., and David Manning, M.D., of the Northwestern University Feinberg School of Medicine in Chicago, Illinois and Dragan Jeremic, […]
The Hintermann Series H2 Total Ankle Replacement System (H2) manufactured by DT MedTech, LLC is now cleared for sale in the U.S. The H2 is a semi-constrained, total ankle replacement prosthesis developed by Professor Beat Hintermann, M.D., a foot and ankle surgeon based in Liestal, Switzerland. The system is indicated for use with bone cement […]
On November 2, 2017, in Manhattan federal court, Columbia, Maryland-based Osiris Therapeutics, Inc.’s former Chief Financial Officer Philip Jacoby pled guilty to recording $1.1 million in revenue in the last quarter of 2014 from the sale of the company’s Ovation bone matrix product, even though the product had been given to a distributor on consignment […]
In what reads like a “Breaking Bad” episode, Johnny Benjamin, Jr., M.D., an orthopedic surgeon at the Pro Spine Center in Vero Beach, Florida, has been charged with distributing, and possibly manufacturing counterfeit oxycodone pills. Benjamin was indicted on October 31, 2017 after a federal investigation, which began in September 2016, looked into the overdose […]
Imagine there’s no need for pre-operative or intra-operative imaging to perform revision hip replacements. Ontario-based Intellijoint Surgical, Inc. has such a system and announced on November 1, 2017 that the FDA has granted clearance to market the company’s revision total hip arthroplasty (THA) using the intellijoint HIP System. intellijoint HIP The company says intellijoint HIP […]
Swiss family-owned Medacta International has received clearance from the FDA to market its Anatomic Shoulder and Reverse Shoulder components of its modular shoulder system in the U.S. The company also announced on October 26, 2017 that the first surgery in the U.S. of the device was performed by Matthew Saltzman, M.D., associate professor of orthopaedic […]
Wade Fallin, the CEO of IntraFuse, says intramedullary fixation is the standard-of-care today for most fractures of the large, long bones of the body due to superior clinical outcomes versus plating systems, yet plating systems are still the standard-of-care for the smaller, long bones of the extremities.” But with the FDA 510(k) clearance of Logan, […]
Jerrold Rosenberg, M.D., a physiatrist of North Providence, Rhode Island, advertised that he can treat joint and back pain without surgery. On Wednesday, October 25, 2017, Rosenberg pleaded guilty to healthcare fraud and conspiring to receive kickbacks from Arizona-based pharmaceutical company Insys Therapeutics Inc. to unnecessarily prescribe a spray version of the highly addictive painkiller, […]
The FDA released three new guidance documents on October 24, 2017 for medical devices to “improve clarity” over the agency’s approval and clearance process. The first, a draft guidance, relates to the agency’s “Breakthrough Devices Program,” which includes an Expedited Access Pathway (EAP) program designed to allow patients to quickly access technologies that have no […]
Astura Medical has been granted clearance from the FDA to market its Bridalveil Occipital-Cervico-Thoracic (OCT) system in the U.S. According to the company’s 510(k) notification summary, the system is a spinal fixation system “intended to stabilize the uppermost portion of the spine during the fusion process. The system contains a wide variety of implants and […]
The FDA has granted 510(k) clearance to Stryker Corporation to combine Mako’s cementless total knee with Triathlon Tritanium. The company reported on October 16, 2017, that the clearance combines the kinematics of the knee implant with the company’s highly porous biologic fixation technology. “The innovation of Tritanium’s tibial baseplate and metal-backed patella components are enabled […]
Heading into the NASS (North American Spine Society) meeting at the end of October, NuVasive, Inc. has announced expanded FDA 510(k) clearances for two of the company’s products. The first, announced on October 12, 2017, was for the PRECICE limb lengthening system. The second, announced four days later, was for the company’s TLX interbody system. […]
Fifty-two years after the FDA approved the first corticosteroid named Kenalog for use in humans, the agency has finally approved an extended-release version of the treatment. Game Changer On October 6, 2017, Flexion Therapeutics Inc. announced FDA approval of Zilretta, the “first and only extended-release, intra-articular injection for osteoarthritis knee pain.” One Wall Street analyst […]
NuVasive’s Pat Miles jumped ship to lead Alphatec. NuVasive is suing accusing Miles of “scheming” to steal employees, secrets and customers. Miles said he’ll clear his name. Here, we detail the allegations. In the meantime, the battle for surgeon customers takes off.
A federal judge in California has given UnitedHealth Group Inc. a big victory against the U.S. Department of Justice (DOJ) over allegations that the company cooked the diagnosis books of patients to boost Medicare Advantage (MA) profits. “Shotgun Pleading” According to Law360, on October 5, 2017, U.S. District Judge John F. Walter wrote that the […]
Wright Medical Technology, Inc. (WMT) and plaintiffs in the Conserve metal-on-metal hip litigation have agreed on a “comprehensive” settlement to settle almost all the last claims against the company. The settlement comes after a patient won an $11 million federal bellwether trial in Atlanta in November 2015. $89 Million In an October 3, 2017 SEC […]
Tom Price, M.D., the orthopedic surgeon and Secretary of Health and Human Services, resigned on September 29, 2017, after seven and a half months on the job. According to the New York Times, President Trump “berated” Price in the Oval Office for about two hours on the day of his resignation because he didn’t like […]
In good news for smaller patients, the FDA has granted 510(k) clearance to Israeli-based Expanding Orthopedics, Inc., to market its interbody FLXfit15 expandable cage. The device was cleared on September 15, 2017 after notification was submitted to the FDA in May. The company stated the device will offer surgeon’s more flexibility with different length options […]
It took the FDA less than three months to clear K2M Group Holdings, Inc.’s Yukon occipito-cervico-thoracic (OCT) fusion system for sale in the U.S. The system is a top-loading, multiple component, posterior OCT spinal fixation system consisting of screws, hooks, rods, rod connectors, and occipital components. The company announced the August clearance on September 29, […]
Scott Gottlieb, M.D., the new FDA Commissioner, wants to revolutionize digital health regulations. On September 26, 2017, he named nine tech companies that will participate in the agency’s digital health software precertification (FDA PreCert) pilot program. The medical device regulators at the FDA are well experienced at pushing hardware through the regulatory approval process. Software […]
When Providence Health in Seattle acquired their local competitor, Swedish Health in 2011, a new focus on volume and revenue shook up existing ways of doing business. Providence brought in Johnny Delashaw, M.D., to pump up revenues. The money came in, but so did the infighting. Professional jealousy? Or did Delashaw cross the line?
The FDA has cleared Stryker Spine division’s 3D-printed Tritanium C Anterior Cervical Cage for the marketplace. A September 20, 2017 company statement said the device is made using Stryker’s proprietary Tritanium In-Growth Technology. The technology involves a highly porous titanium material designed for bone in-growth and biological fixation. The company says Tritanium material may be […]
The FDA wants its staff to get smarter about reviewing medical devices. To do that, the agency developed the Experiential Learning Program (ELP) to bring in device experts to train the FDA staff. On September 13, 2017, Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) announced the FDA has chosen the consultants to lead three training sessions […]
Medtronic plc has received Supplemental PMA (premarket application) Approval from the FDA for the world’s smallest implantable spinal cord stimulator. The announcement of the approval came on September 18, 2017. The company then also announced the U.S. launch of the Intellis platform for the management of certain types of “chronic intractable pain.” The platform includes […]
Bioventus LLC scored a rare orthopedic FDA Premarket Approval (PMA) on August 29, 2017, for its single-injection hyaluronic acid (HA) joint lubrication product Durolane. Over 20 million Americans suffer pain from knee osteoarthritis (OA). But, said company CEO Tony Bihl, the associated pain can be managed. Durolane has been a “proven knee OA pain reliever […]
NuVasive, Inc. has won 510(k) clearance to market a magnetic technology and adjustable growth rods to treat early-onset scoliosis. Early-onset of scoliosis used to be a sentence of possible endless surgeries to straighten out the spine. Then came growing-rod surgical and genetic solutions to predict curvature growth and apply appropriate interventions. But with 72% of […]
With FDA 510(k) clearance of its Swedge pedicle screw system, Florida-based Spinal Resources, Inc. says the company has now transitioned from a design and distribution firm to a full manufacturer of surgical products. For its first product development effort, the company introduced the Swedge Pedicle Screw System, which has three rod sizes in one tool. […]
Dan Resnick, M.D. is the First Vice President of the North American Spine Society (NASS). In October, he will become the Society’s President. In the 2017 July/August edition of SpineLine, Resnick writes an editorial titled, Politics, Practice and Professionalism. His views on politics and public policy are timely given there is an administration in Washington, […]
“Breakthrough technology” and performing a “perfect total knee replacement” is how OMNIlife science, Inc. described its Active Spacer robotic tissue balancing device just cleared by the FDA. In a September 6, 2017 announcement, the company said the new technology, in clinical use since March in Australia, “provides the surgeon with a quantitative tool to actively […]
If you are a medical device manufacturer seeking premarket approval (PMA) for your device, your tool chest for evidence gathering just got a lot bigger. The 21st Century Cures Act required the FDA to develop a framework and guidance for evaluating real-world evidence (RWE) and data (RWD) in approving new medical devices and medicines. In […]
Knoxville, Tennessee-based ChoiceSpine LP’s TOMCAT Anterior Cervical Discectomy and Fusion (ACDF) procedure has been successfully completed for the 1,000th time. On August 23, 2017, the company announced that the milestone had been reached on a patient at St. Mary’s Hospital in Athens, Georgia, by Julian Price, M.D., a surgeon at the Athens Orthopedic Clinic. Price […]
It’s going to cost device companies more than double what they paid for 510(k) Clearances in 2018 than in 2017. In August, the U.S. Senate voted overwhelmingly to reauthorize the FDA’s user fees agreement with medical device manufacturers for another five years. The President promptly signed the bill which called for an overall user fee […]
Portugal-based PeekMed has received ISO 13485 certification for its 3D pre-operative system and can now sell the system all over Europe, according to an August 31, 2017 announcement from the company. The system had already received CE mark approval. ISO 13485 is an internationally agreed standard that sets out the requirements for a quality management […]
Former ArthroCare Corporation CEO Michael Baker has been convicted for a second time by a federal jury for his role in orchestrating a fraud scheme that resulted in shareholder losses of over $750 million. Baker and Michael Gluk, the company’s former CFO, were originally convicted in June 2014 for running a scheme to generate false […]
Dr. Tom Price and CMS want to change bundled payments for joint replacement surgeries from mandatory to voluntary. How will this affect the overall move towards value-based reimbursement systems? The heads of Medtronic and AAOS and a prominent bundled payment consultant offer some (perhaps) surprising insights on the topic. Read what they said.
Globus Medical, Inc. finally has its own robotic system to market in the U.S. After asking the company to resubmit its 510(k) clearance application for the ExcelsiusGPS robotic guidance and navigation system back in May, the company announced the FDA granted clearance to market the system in the U.S. on August 17, 2017. The FDA […]
The burden of proof on whistleblowers demonstrating specific claims for reimbursement in a False Claims case, has become more flexible. DePuy Orthopaedics, Inc. is feeling the result of that flexibility. After having a Pinnacle hip implant metal-on-metal whistleblower False Claims lawsuit thrown out because the whistleblowers didn’t show a direct connection between the device and […]
The FDA has granted 510(k) clearance to Renovis Surgical Technologies, Inc. to market its posterior lumbar Tesera porous titanium interbody fusion systems. An August 11, 2017 company press release stated that the systems feature “implants for direct posterior (PLIF) or transforaminal (TLIF) approaches in both straight and curved options.” Multiple heights, widths and lengths are […]
On August 16, 2017, the company announced the screw, used in the non-cervical spine, received 510(k) Clearance from the agency. The company says the screw features enhanced serrated cutting flutes, a “unique” dual-thread pattern with an increased number of leads for rapid insertion, and a patented buttress thread locking mechanism designed to “minimize cross threading […]
What is your sex life worth if it has been taken away because of a failed back surgery? On August 2, 2017, a state jury in Oregon, awarded more than $4.5 million to a couple after the 30-year-old husband underwent a failed spine surgery which left him with numbness in his genital area, seriously altering […]
In2Bones Global, Inc. announced on August 8, 2017, that its In2Bones USA, LLC subsidiary has received FDA (510k) clearance for a new foot fracture and correction system. The system will be marketed under the 5MS Fracture Repair System and the CoLag Locking Compression Screw System brand names. The fracture repair system is a comprehensive plate […]
If your practice receives incentive payments to use electronic health records (EHR), pay attention. In June, the Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) said Centers for Medicare and Medicaid Services (CMS) overpaid federal EHR incentive payments to providers by $729 million over the last six years. The OIG says […]
FDA review times for device manufacturers should go down after the U.S. Senate voted 94-1 on August 3, 2017 to reauthorize the FDA’s user fees agreement for another five years. The biggest changes to the previous user fee agreement is that device manufacturers will see an increase of more than $320 million in user fees […]
The FDA’s Arthritis Advisory Committee voted 12-1 on August 2, 2017 to deny approval for Johnson & Johnson’s rheumatoid arthritis (RA) drug, Plivensia (sirukumab). The drug works by blocking a cytokine in the body known as interleukin 6 (IL-6) that can contribute to the inflammation associated with rheumatoid arthritis. The company was seeking BLA (Biologics […]
In July 2011, Michael Thomas, D.O., a neurosurgeon in Washington State, performed spinal surgery on Emily Daley to treat her scoliosis. Six years later, on July 31, 2017, a Washington state jury awarded Daley $1.2 million in a medical malpractice lawsuit because Thomas’s “negligent” surgery caused her severe spinal deformity. The jury took six hours […]
A man, whose wife is suffering from pain, goes to an orthopedic surgeon and demands an opioid pain killer prescription. The surgeon declines, so the husband shoots and kills him. That nightmare scenario happened in Mishawaka, northern Indiana on July 26, 2017. Todd Graham, M.D., of South Bend Orthopedics, had an appointment with a new […]
A man, whose wife is suffering from pain, goes to an orthopedic surgeon and demands an opioid pain killer prescription. The surgeon declines, so the husband shoots and kills him. That nightmare scenario happened in Mishawaka, northern Indiana on July 26, 2017. Todd Graham, M.D., of South Bend Orthopedics, had an appointment with a new […]
From the largest False Claims bust in history, to alleged Medicare Advantage upcoding schemes, the filing of healthcare fraud charges, allegations and settlements in 2017 are making big news. What are these cases all about? Read it here.
When does a “free service” violate the False Claims Act? A recent Pennsylvania case involving Medtronic plc put some parameters around that question. In a whistleblower suit filed by a Medtronic district manager, the company was accused of offering surgical support and other free services as kickbacks to induce surgeons and hospitals into buying the […]
Stryker Corp has received 510(k) Clearance from the FDA to sell their new radiofrequency ablation device. The clearance, announced on July 11, 2017 by the company, is for the MultiGen 2 RF Generator used during a minimally invasive procedure to relieve facet joint pain. The generator is being debuted at the 25th annual meeting of […]
Amgen Inc.’s osteoporosis drug romosozumab (romo) has been rejected by the FDA. On July 16, 2017, the company announced that its marketing application for the drug was rejected after missing a key secondary endpoint and running into recent safety issues. The FDA, according to the company, wants Amgen to include data from two late-stage studies—the […]
Medtronic plc says it has reached an agreement with “substantially all” remaining claimants involving the Infuse bone graft product. In a June 27, 2017 10K filing with the SEC, the company announced the agreements with approximately 6,000 claimants. The company also said it has set aside $300 million for “certain litigation charges” in the filing. […]
On July 13, 2017, the government announced the largest ever health care fraud bust by the Medicare Fraud Strike Force. 412 Arrested The Department of Justice (DOJ) said it arrested 412 defendants across 41 federal districts, including 115 doctors, nurses and other licensed medical professionals, for their alleged participation in health care fraud schemes involving […]
The patent fight between Stryker Corporation and Zimmer Biomet Holdings, Inc. over a surgical cleaning device seems to have finally reached a conclusion on July 12, 2017 as Robert Jonker, a U.S. federal judge in Michigan awarded Stryker $248.7 million. This case established a new standard by the U.S. Supreme Court over the discretion allowed […]
The latest 2016 Open Payments update from the Centers of Medicare and Medicaid Services (CMS) has been posted for payments from industry to physicians and teaching hospitals. We looked at the top 10 publicly traded orthopedic and spine device companies that paid a total of $434 million to 83,600 physicians and teaching hospitals in 2016. […]
Dave Dvorak has resigned, unexpectedly, as president and CEO of Zimmer Biomet Holdings, Inc. The announcement on July 11, 2017, made by the company’s Board of Directors at the close of the day, stated that Dvorak resigned “effective today.” Zimmer Under Dvorak Larry Glasscock, chairman of the company’s Board of Directors didn’t say Dvorak was […]
United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) issued an alert on June 29, 2017 to healthcare professionals with updated recommendations for long-term follow-up for patients with metal-on-metal (MoM) hip replacements. Five years ago, MHRA recommended annual screening involving blood tests and imaging for all patients with MoM replacements that showed symptoms of tissue […]
K2M Group Holdings, Inc. sandwiched two FDA 510(k) Clearances around the Fourth of July. One for a 3D printed corpectomy cage and, the other, for a spinal proximal fixation system. On June 28, 2017, the company announced the clearance of the Capri Small 3D Static Corpectomy Cage System. Calling the clearance, a milestone for the […]
Zimmer exec Dave Dvorak has had a stellar record with mergers and integration. But the 2015 Biomet acquisition brought some big challenges. An internal quality audit and FDA inspection at the Biomet North Campus caused big production delays. Dvorak acted fast. Read what he told analysts about fixing the North Campus Blues.
The ex-pharmacist from the New England Compounding Center (NECC) who sold deadly epidural steroid injections used to treat back pain, neck, knee and other types of pains, is going to jail for nine years. 64 Dead In October 2012, the North American Spine Society issued a Spine Safety Alert after a rare form of fungal […]
K2M Group Holdings, Inc. stakes claim to be the first leading spine company to market a 3D-printed titanium interbody device. Now the company is adding to its portfolio after receiving 510(k) clearance for its MOJAVE PL 3D Expandable Interbody System. That clearance, according to a June 22, 2017 company announcement, allows the company to be […]
ConforMIS, Inc. has had an FDA cleared customized knee replacement system for over a decade. On June 14, 2017, the FDA granted the company 510(k) clearance to market its primary iTotal Hip system. According to a June 20, 2017 company press release, the ConforMIS iTotal Hip system features proprietary iFit technology similar to that used […]
The Medicrea Group has received FDA 510(k) Clearances for the company’s PASS Tulip top-loading fixation construct and its UNiD HUB digital portal for the company’s Adaptive Spine Intelligence (ASI). PASS TULIP Construct The construct, according to the June 16, 2017 company announcement, is the world’s first patient-specific hybrid construct. The components are fully compatible with […]
SI-BONE, Inc. has received FDA clearance and a patent for its iFuse-3D implant. In a June 13, 2017 announcement, the company said the implant provides 250% greater porous surface area than its original iFuse implant and uses a patented fenestrated design and enhanced porous surface that resembles the trabecular structure of cancellous bone. To receive […]
After an FDA inspection of a Biomet knee production facility in Jinhua City, Zhejiang, China, conducted in January 2015, the agency issued the company a Warning Letter. The agency said methods used at the facility were not in conformity with good manufacturing practice requirements. On May 18, 2017, the agency notified, now Zimmer Biomet Holdings, […]
In late May, officials of the Israel Securities Authority (ISA) searched the Israeli offices of Mazor Robotics, Ltd. On June 8, 2017, the company publicly announced the search and noted the ISA had questioned certain officers in connection with an investigation being conducted by the agency. In a U.S. Securities Exchange Commission (SEC) filing the […]
Due to requirements of the 21st Century Cures Act, it just got easier for medical device makers to get approval from the FDA for devices falling under the Humanitarian Device Exemptions (HDEs) category. In a June 7, 2017 filing in the Federal Register, the agency announced amendments that change the threshold of number of individuals […]
The long road for redemption for former Stryker Corporation sales rep Christopher Ridgeway is not ending well for him. On May 25, 2017, MassDevice reported that the U.S. Court of Appeals for the 6th Circuit sided with Stryker after Ridgeway appealed a lower court ruling in the company’s favor. In 2013, Stryker sued and accused […]
Another bone graft substitute for postero-lateral spinal fusion has been cleared by the FDA. On June 1, 2017, New Jersey-based Prosidyan, Inc., announced the FDA clearance to market the company’s FIBERGRAFT BG Putty, the second generation of the company’s proprietary fiber-based bioactive glass products. The company stated the putty “leverages the direct connectivity of fibers […]
On April 20, 2017 Zimmer Biomet Holdings, Inc. sent an Urgent Medical Device Removal notification to all affected customers implanted with SpF PLUS-Mini and SpF XL IIb Implantable Spinal Fusion Stimulators. The stimulators are used during spinal fusion surgery to increase the possibility of permanently connecting two or more bones of the spine together. The […]
SurGenTec LLC has been granted a patent for its bone graft delivery technology by the U.S. Patent and Trademark Office. The proprietary Graftgun Delivery System enables surgeons to deliver the bone graft of their choice (synthetic, allograft, or autograft) in a minimally invasive fashion. In a May 25, 2017 announcement, the company stated that traditionally, […]
President Trump wants the medical device and pharmaceutical industries to pay the full cost to push devices and drugs through the FDA. His budget proposal released on May 23, 2017, will basically double medical product user fees to finance the full cost of FDA pre-market review and replace the need for new appropriated budget authority. […]
The FDA has informed Globus Medical, Inc. that the agency is not granting 510(k) clearance for the company’s ExcelsiusGPS robotic guidance and navigation system. The company issued an SEC filing on May 17, 2017 regarding the FDA’s notification letter dated two days earlier. The FDA letter, according to the company’s filing, stated the agency does […]
The FDA has cleared Life Spine, Inc.’s Cranial Fusion System for use with the company’s Solstice polyaxial screws for cervical spine indications. Mariusz Knap, the company’s vice president of marketing, said this was an exciting opportunity to use the Solstice system screws for posterior cervical fusion. According to a May 9, 2017 announcement, the Cranial […]
Spook technology stolen from U.S. spy agencies was used by hackers in a phishing cyberattack that crippled Britain’s National Health Service and computers worldwide. Outdated healthcare computer systems make healthcare systems easy targets. Read about this attack and see what you can do to keep patients safe.
Stryker Corporation is putting lawsuits over its Rejuvenate Modular-Neck hip stem and ABG II Modular-Neck hip stem in the rearview mirror. On May 8, 2017, the company announced that 95% of additional registered eligible patients have enrolled in the Settlement Program under the Master Settlement Agreement announced in December 2016. The 2016 Settlement Program follows […]
CurveBeam President and CEO Arun Singh says his company’s CT imaging system for extremities, just cleared by the FDA, will “revolutionize the speed and accuracy of assessment of upper extremity conditions [such as scaphoid fractures] that specialists have traditionally found challenging to diagnose with plain X-Ray.” The Warrington, Pennsylvania-based company announced the 510(k) clearance for […]
The U.S. Senate approved Scott Gottlieb, M.D. as the next FDA Commissioner on May 9 by a vote of 52 to 47. Deregulation Advocate Gottlieb has a track record as an advocate for deregulation and was on President Trump’s transition team. Earlier, he was a senior adviser to the presidential campaign of Wisconsin Governor Scott […]
The U.S. Senate approved Scott Gottlieb, M.D. as the next FDA Commissioner on May 9 by a vote of 52 to 47. Deregulation Advocate Gottlieb has a track record as an advocate for deregulation and was on President Trump’s transition team. Earlier, he was a senior adviser to the presidential campaign of Wisconsin Governor Scott […]
On May 1, 2017, Medtronic plc issued a communication letter cautioning healthcare providers against using the company’s NavLock Tracker with instruments not cleared to be used with the device. The company said it was updating the labeling on the device. The device is used in Medtronic’s StealthStation surgical navigation system used during spinal fusion and […]
Implanet’s newest addition to its spinal stabilization system using a strapping or banding method instead of inserting pedicle screws and rods has received European marketing clearance (CE). A May 3, 2017 clearance announcement of the JAZZ Standalone implant states the implant is part of the company’s freestanding, rodless fixation line launched in 2016 with the […]
On April 28, 2017, the FDA approved another drug to treat osteoporosis in postmenopausal women at high risk of fracture or those who have failed other therapies. The drug, Radius Health Inc.’s Tymlos, is given by injection. In clinical trials, the drug was shown to reduce the absolute risk of spine fractures by 3.6% compared […]
The FDA has granted German-based joimax GmbH 510(k) clearance for a patented device which generates electrical power for monopolar and bipolar cutting and coagulation of tissue structures in endoscopic surgical operations. The announcement was made at the Annual Scientific Meeting of the American Association of Neurological Surgeons (AANS) 2017, in Los Angeles, California. The Endovapor […]
The federal judge that awarded Texas spine surgeon Mark Barry, M.D., $20.3 million after finding that Medtronic, plc “actively induced” infringement of patents covering spinal deformity repair services held by Barry, has thrown in an additional 20% given evidence of “reckless” copying by the company. Lenke and Medtronic Errors Law 360 reported on April 21, […]
The U.S. Food and Drug Administration (FDA) has given 510(k) market clearance to Life Spine, Inc.’s PLATEAU-C Ti Cervical Spacer System. An April 19, 20917 company announcement states the system offers the company’s proprietary titanium surface technology, OSSEO-LOC, which is a surface technology that helps create an environment for potential bone growth. Additionally, in comparison […]
Last June we reported on Treace Medical Concepts, Inc., a small Florida company founded in early 2014 with a proprietary bunion deformity treatment called Lapiplasty®. On April 18, 2017, the company announced that the U.S. Patent and Trademark Office issued U.S. Patent No. 9,622,805 which broadly covers the methods of multi-planar bunion correction embodied by […]
Taiwan-based United Orthopedic Corporation’s E-XPE polyethylene knee insert has been cleared by the FDA for sale in the U.S. According to an April 12, 2017 company announcement, the insert is designed to provide patients with knee replacements with reduced risk of oxidation. Calvin Lin, president of United Orthopedic Corporation USA, said, “Oxidation continues to be […]
Caesarea, Israel-based Mazor Robotics Ltd, has received FDA clearance for its Mazor X Align software. The software is designed to assist surgeons in planning spinal deformity correction and spinal alignment for procedures performed with the Mazor X Surgical Assurance Platform In an April 12, 2017 announcement, the company said this is the latest module to […]
If the U.S. Senate gives its blessing, the FDA is about to get a new leader in Scott Gottlieb, M.D. Gottlieb has been an advocate of speeding the approval process through shorter trials. On April 6, 2017, perhaps sensing the changing tide, the medical device scientists at the FDA, led by Jeff Shuren, M.D. and […]
The FDA has cleared an over-the-counter (OTC) drug-free pain therapy for pain related to plantar fasciitis of the heel and osteoarthritis of the knee. The therapy is a wearable non-prescription medical device called ActiPatch from BioElectronics Corp. The company develops wearable, neuromodulation devices to mitigate neurologic diseases and, according to the company, to safely improve […]
The failure to repeal and replace the Affordable Care Act (ACA) with the American Health Care Act (AHCA) was a good thing for medical device companies. Wells Fargo Analyst Larry Biegelsen offered that assessment on March 29, 2017 after hosting a conference call with investors and Vince Ventimiglia, a former Republican congressional staffer and assistant […]
The FDA is delaying its plan to amend regulations regarding “intended uses,” and wants your input. This is a big deal to medical device companies because any ambiguity about intended use on a device label can get you into hot water with the Justice Department in a hurry. A product’s “intended use” matters and the […]
Each year, the Food and Drug Administration (FDA) publishes two lists of Draft Guidances the agency hopes to finalize during the next year. The agency divides these into “A” and “B” lists, based on which guidances are most important. In February 21, 2017, medical device companies, through the largest industry group, AdvaMed, identified 7 of […]
A private Brazilian insurance group claims U.S. orthopedic and other implant device makers and the U.S. government allegedly violated the Foreign Corruption Act. In numerous private lawsuits, the group alleges a “Prosthetic Mafia” gorged payers.
NuVasive, Inc. announced on March 29, 2017, that it is the first company to receive clearance from the FDA for intervertebral body fusion for up to four contiguous levels in the cervical spine. Due to cervical radiculopathy and myelopathy secondary to cervical degenerative discs in adult patients, more than 200,000 cervical surgical procedures are performed […]
Stryker Corporation now has FDA clearance to use the company’s own cements, implants, and the AutoPlex mixing and delivery system with its AVAflex balloon system to treat vertebral compression fractures (VCF). The system mixes, transfers, and primes bone cement for delivery in less than 60 seconds through a single incision. Stryker bought the technology from […]
The FDA has granted expanded 510(k) clearance for Minnesota-based Spineology, Inc.’s Elite expandable interbody fusion system. The company completed a limited release of the system in November 2016. This clearance adds a narrower, 10mm, version of the device and an indication to utilize the devices with allograft bone. The implant is inserted into the disc […]
DJO Global, Inc. says the company developed a revision hip which saves time and money in the OR. Now the company has FDA 510(k) clearance for its Exprt Revision Hip portfolio. Price Point Efficiency Mark Russell, the company’s surgical division’s senior vice president, said in a March 15, 2017 press release, “One of the biggest […]
Our orthopedic surgeon and Health and Human Services Secretary, Tom Price, M.D., has said he is no fan of mandatory bundled payments. After just taking office in February, he’s already putting on the brakes to the payment model with the March 20, 2017 announcement that the expansion of hip and knee replacement bundled payment programs […]
To be good at managing the risks of a bundled payment program, you need data. Lots of data about your individual patients and your patient population. On March 15, 2017, it was announced that the largest member-owned health care performance improvement company in the U.S., Vizient, Inc., granted an Innovative Technology contract to Scientific Analytics, […]
Indiana healthcare consultant Seema Verma is to head the Centers for Medicare and Medicaid Services, President Trump has put in place his top Obamacare Busters.
Medtronic plc has had FDA permission to market its Kyphon Xpede Bone Cement for the treatment of vertebral fractures for some time. On March 14, 2017, the Dublin, Ireland-based company said it has now received 510(k) FDA clearance to market the cement, “for fixation of pathological fractures of the sacral (pelvic) vertebral body using sacral […]
If Congress approves, Scott Gottlieb, M.D. will become the new head of the Food and Drug Administration (FDA). His job will be to translate into policy what his future boss, President Trump, wants him to do about “slashing restraints” of a “slow and burdensome approval process” at the FDA. The White House announced the nomination […]
The FDA has approved a new extended-release opioid with abuse-deterrent properties. This is important for orthopedics. For instance, patients with long-lasting, chronic back pain, particularly after multiple surgeries, are sometimes prescribed opioid or narcotic medications. In fact, one study cited by WebMD, showed that as many as 70% of back pain patients receive opioids. These […]
The FDA inspection process for device manufacturers is getting some bi-partisan attention in Congress. On February 15, 2017, U.S. Senators Michael Bennet, a Democrat from Colorado and Johnny Isakson, a Republican from Georgia introduced a bipartisan bill (S.404) to modernize the FDA’s medical device inspections process. “FDA inspections are supposed to ensure that companies provide […]
Former Stryker Corporation sales rep Christopher Ridgeway and Stryker are still in federal court over the company’s firing of Ridgeway in 2013. The company sued and accused Ridgeway and Biomet, Inc. of poaching other Stryker reps in New Orleans to join Biomet. Stryker also accused Ridgeway of running other medical device supply businesses on the […]
The FDA has identified Zimmer Biomet Holdings, Inc.’s December 15, 2016’s Comprehensive Reverse Shoulder recall a Class I recall. This class of recall is the most serious type because use of the devices may cause serious injuries or death. The company recalled the 3,662 devices because these devices are, according to the FDA, “fracturing at […]
The FDA issued a final rule regarding intended use labeling on January 9, 2017 that sent device and drug makers into convulsions. The final rule requires manufacturers to “provide…adequate labeling”…if the “totality of the evidence” establishes that a manufacturer objectively intends that a device [or drug] introduced into interstate commerce by the manufacturer is to […]
A Medtronic plc radiofrequency (RF) energy ablation system originally cleared for use in the spine, now has FDA clearance to be used for palliative treatment of metastases in all bony anatomy—such as ribs, sacrum, extremities, and hips—in patients who have failed or are not candidates for standard therapy. In announcing the clearance of the OsteoCool […]
Aria Sabit, M.D. is going to jail for almost 20 years if he completes a sentence imposed in January by a federal judge in Michigan. Sabit pled guilty back in May 2015 to a $2.8 million healthcare fraud scheme for filing false claims that the government said, “caused serious bodily harm to patients by performing […]
Zimmer Biomet Holdings, Inc. has had a multi-district litigation (MDL) case over its NexGen Flex knee implant for some time. At least 5,900 product liability lawsuits have been consolidated into that MDL under U.S. District Judge Rebecca Pallmeyer in Northern Illinois. But on January 26, 2017, as reported by MassDevice, the company won its third […]
Are you a medical device manufacturer getting ready to start a clinical trial or submit notification or approval requests to the FDA? Hang on to your hat. President Trump is a man of his word when it comes to his campaign promises to cut government regulations. On January 30, 2017, he signed an executive order […]
The FDA has given Zimmer Biomet Holdings, Inc. permission for an expanded 26-week efficacy claim for its single-injection viscosupplement Gel-One Cross-linked Hyaluronate for the treatment of knee pain associated with osteoarthritis. Gel-One, according to the company, is indicated for knee osteoarthritis patients who have failed to respond adequately to non-pharmacologic therapy, non-steroidal anti-inflammatory drugs (NSAIDs) […]
On January 16, 2017, SpineGuard, Inc. announced that it received 510(k) clearance from the FDA for its new DSG integration module to be used in combination with Zavation LLC’s spinal fusion system to make Zavation’s pedicle screws “smart.” The companies first announced their collaboration effort back in March 2015 and are now able to market […]
Zimmer Biomet Holdings, Inc. has a lot of ‘splaining to do to the FDA after an inspection of the company’s Warsaw, Indiana, plant resulted in one the “longest and most serious” 483s ever encountered by a legal expert quoted by Wells Fargo Analyst, Larry Biegelsen. FDA 483s are “Inspectional Observations,” used by the FDA to […]
The Department of Justice (DOJ) obtained more than $4.7 billion in settlements and judgments from civil cases involving fraud and false claims in fiscal year 2016. Of that $4.7 billion recovered, $2.5 billion came from the healthcare industry, including drug companies, medical device companies, hospitals, nursing homes, laboratories, and physicians. The biggest recoveries came from […]
The public is going to get information on recalled medical devices a little quicker in 2017. The FDA announced on January 3, 2017 that the agency is posting device recall information on its website earlier than in previous years. The FDA used to post device recall information only after the agency announced the company’s initiation […]
There is a new pocket-size point-of-care instrument available in the U.S. to help in osteoporosis diagnosis after the FDA recently granted 510(k) clearance for Kuopio, Finland-based Bone Index Ltd.’s second-generation Bindex device. Bindex, according to a company announcement, measures the cortical bone thickness of the tibia and an algorithm calculates the Density Index, a parameter […]
It’s official and completes a long regulatory, legal and scientific journey. Effective December 30, 2016, pedicle screw systems became classified as a Class II/special controls device by the FDA. The agency is also renaming the device “thoracolumbosacral pedicle screw systems.” Four years ago, after years of off-label use, the FDA’s orthopedic panel finally recommended that […]
Robert D. Delp is assuming the position of President, Americas and joining the executive leadership team of Zimmer Biomet Holdings, Inc.
DePuy Synthes Products, Inc. is acquiring Interventional Spine, Inc.’s expandable cage and minimally invasive surgery (MIS) technologies for spinal fusion. In a January 3, 2017 announcement, DePuy Synthes said the asset agreement is the “latest example of the Johnson & Johnson Medical Devices strategy of investing in innovation in key platforms that will drive future […]
Whale Imaging, Inc.’s marketing team believes its recently FDA 510(k) cleared G-Arm Duo imaging system has the chance to “revolutionize” the way surgeons carry out their surgical procedures. Company officials told OTW this is because, “compared to traditional C-Arm devices, our machine provides two planes of view at the same time. To accomplish this with […]
The FDA has granted Supplemental Approval for a mobile device app for Orthofix International N.V.’s bone graft stimulators that help patients follow their prescription and allows their physicians to see if the patients are following instructions. On January 9, 2017, the company announced the approval for its CervicalStim and SpinalStim bone graft stimulators. There’s an […]
In a year of elections, tweets and disruptions, readers of Orthopedics This Week were focused on innovative technologies, the state of the orthopedic industry, prosecutions and a continued curiosity of the best ways to care for patients. According to Google Analytics, the following were the most viewed stories in OTW in 2016.
On December 28, 2016, the 8th U.S. Circuit Court of Appeals in St. Paul, Minnesota, said a lower court judge erred in finding that a group shareholders sued too late, by waiting more than two years after learning information that could suggest an intent to defraud. The plaintiff Medtronic shareholders, include the West Virginia Pipe […]
On December 23, 2016, the FDA’s Center for Devices and Radiological Health (CDRH) issued a list of 12 final guidance documents and four draft guidances that the agency intends to publish in the next year. The agency also provided a website where you can comment on the lists. Click here. During negotiations on the Medical […]
The scientists and regulators at the FDA want those who look to the agency to protect and promote public health to know that there is a “science” to their decision-making progress. To that end, the agency’s medical device regulators issue a yearly ‘Regulatory Science’ top ten list of priorities. For the New Year, it’s all […]
Stryker Corporation is planning a new Research and Development (R&D) center in Portage, Michigan. Michigan economic development officials are kicking in $1 million and promises of future tax breaks to get Stryker (putting up $130 million of its own money in the project) to build the center near the company’s corporate headquarters in Kalamazoo. According […]
Zimmer Biomet Holdings, Inc.’s Trabecular Metal Cups are associated with lower infection rates and a significant reduction in subsequent hip revision rates. That’s according to data reported by the company on December 14, 2016 from a new report by the National Joint Registry (NJR) for England, Wales, Northern Ireland and Isle of Man. The pool […]
Orthofix International N.V. announced on December 13, 2016, that Lukianov is now one of the company’s board members.
As often happens, private payers follow Medicare’s lead in reimbursement policies. UnitedHealthcare is following the agency’s lead by adopting a bundled payment model for hip, knee and spine surgeries. Why? To save money, of course. In a December 1, 2016 press release, Michelle Lobe, UnitedHealth’s vice president of network strategy and innovation, said the main […]
Zimmer Biomet Holdings, Inc. and the U.S. Department of Justice (DOJ) are going to reach a settlement over Biomet, Inc.’s alleged bribery of state-employed healthcare providers in Argentina, Brazil and China. According to a court filing submitted by the DOJ on December 8, 2016, the settlement will be reached in the next four weeks. Biomet […]
Another Jacksonville, Florida-based orthopedic group has agreed to settle false claims allegations with Assistant U.S. Attorney, Jason Mehta. On December 7, 2016, Mehta and the Department of Justice (DOJ) announced that Southeast Orthopedic Specialists (SOS) agreed to pay the government $4.488 million to resolve allegations that it violated the False Claims Act. The government alleges […]
After two years of negotiations, the U.S. House of Representatives and Senate passed the 21st Century Cures Act on December 7, 2016. More Research, Faster Approvals Supporters say the Cures Act will speed access to new drugs and devices, in part by allowing clinical trials to be designed with fewer patients and cheaper, easier-to-achieve goals. […]
A federal jury in Texas awarded $40 million in compensatory damages to six people implanted with DePuy Orthopaedics Inc.’s Pinnacle metal-on-metal hip implant in December 1, 2016. Then the jury awarded more than $1 billion in punitive damages. The staggering punitive award is sobering for J&J (Johnson & Johnson), DePuy’s parent company, considering there are […]
Orthopedic surgeon Dr. Tom Price is in charge of implementing President-elect Trump’s promise to repeal and replace Obamacare. He faces a 2, 000 page long law and a Rubik’s Cube of rules and regulations. But he is the right guy for the job having led the Republican effort over the last couple of years to design an alternative plan. Can Obamacare be untwisted? What does it mean for orthopedics? We find out.
Zimmer Biomet Holdings, Inc. has joined Stryker Corporation as a “preferred” orthopedic partner with the Indo UK Institutes of Health (IUIH). The company’s announcement on November 22, 2016 follows Stryker’s partnership announcement with the IUIH just a week earlier. Money, Joints, Protocols and Education Zimmer Biomet’s commitments to the program include: an equity investment in […]
Representative Tom Price, M.D., an orthopedic surgeon from Atlanta and chairman of the U.S. House of Representative Budget Committee, has been chosen by President-elect Donald Trump to be the new Secretary of the Department of Health and Human Services (DHS). Trump said Dr. Price is “exceptionally qualified” to help replace Obamacare. The surgeon said there […]
In early November, a federal jury in Texas awarded Mark Barry, M.D., $20.3 million after finding that Medtronic, plc “actively induced” infringement of patents covering spinal deformity repair services held by Barry, who sued the company in 2014, alleging infringement of a trio of patents. Barry claimed that the company’s CD Horizon Legacy spinal system […]
Medtronic Inc.’s Kyphon division has lost another legal round with Pabban Development Inc. over Medtronic’s 2008 purchase of Pabban’s Natrix System. Irvine, California-based Pabban developed the Natrix System, which is a hand pump and tube used by spinal surgeons to deliver medical cement into a patient’s spine during a kyphoplasty. On Wednesday, November 16, 2016, […]
Zimmer Biomet Holdings, Inc. has introduced a personalized shoulder implant called the Comprehensive Vault Reconstruction System (VRS) for patients with a severely deficient rotator cuff and extensive bone loss which precludes the use of a standard glenoid baseplate. Until now, treatment options for extensive glenoid deficiencies were limited to bone grafting or hemi-arthroplasty, said David […]
The FDA wants to improve the way researchers collect race and ethnicity data in clinical trials. On October 26, 2016, the agency updated guidance documents to reflect requirements under the 2010 Affordable Care Act (ACA) and the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA). Citing a 2008 study by SM Huang and […]
Stryker Corporation has taken a very big step into India with a November 14, 2016 announcement that the company and Indo UK Institute of Health (IUIH) have partnered up to provide greater access and affordable primary joint replacements and other healthcare services to patient in India. Stryker announced the 20-year partnership with the institute’s Medicity […]
Medtronic plc has introduced a free consulting service to their hospital customers to manage their financial risks under Centers for Medicare and Medicaid Services (CMS) recently implemented Comprehensive Care for Joint Replacement (CJR) model. In a November 10, 2012 announcement, the company said Medtronics Orthopedic Solutions was developed in partnership with physicians who have successfully […]
Got back or leg pain? Medtronic Canada and Health Canada have a deal for you. According to a November 8, 2016 press release, Medtronic Canada’s new Specify SureScan MRI surgical leads, part of Medtronic plc’s spinal cord stimulation (SCS) implant system, is now licensed by Health Canada. Health Canada is the federal department responsible for […]
Donald Trump wants to repeal and replace Obamacare. “We have to take care of the people in our country. We can’t let them die on the sidewalks of New York or the sidewalks of Iowa or anywhere else.” Sounds good. Except his plan costs the public purse almost $500 billion over ten years and removes over 20 million people from insurance coverage. What’s in the plan? Read it here.
When it comes to spine, do Black Lives Matter? Apparently, they do. But not for the better. Black patients are more likely to be readmitted within 30-days of discharge after elective spine surgery. That’s according to a study reported in the November issue of Spine: (1 November 2016 – Volume 41 – Issue 21 – […]
Wright Medical Technology, Inc. has entered into settlement agreements with patients and insurance carriers over lawsuits resulting from claims over the company’s Conserve metal-on-metal hip implant. The Master Settlement Agreement (MSA) with court-appointed lawyers represents 1, 292 individual claims for a total settlement of $240 million, or about $185, 000 per claim. Terms of the […]
Medicare has finally released the new post-SGR payment world rules. Here’s what you need to know about getting paid for quality and what device companies, clinicians and health systems are doing to differentiate themselves to capture the bundle.
Some of the nation’s largest and most prominent hospitals failed to report medical device-related deaths or serious injuries, according to FDA findings from inspections dated December 2015 through April 2016. On October 24, 2016, the FDA announced the hospitals that didn’t report deaths as required were Advocate Lutheran General in Park Ridge, Illinois; Huntington Memorial […]
DePuy Synthes Spine has a new ALIF (anterior lumbar interbody fusion) implant designed for “surgical efficiency.” On October 27, 2016, the company announced the launch of the Synfix Evolution System. The system, according to the company, is stand-alone and provides biomechanical stability to promote fusion and restore function. The system offers a broad range of […]
On October 21, 2016, the FDA launched a new website for reporting alleged regulatory misconduct by medical device makers. The agency made the move after a report came out in the Minneapolis Star-Tribune which revealed that the FDA has accepted late adverse event reports from device companies for hundreds of thousands of incidents. Any person […]
Under the bundling payment system for hips and knees, providers are given a lump sum for an entire episode of care, ending 90 days after a procedure is performed. Studies have shown that the largest variable in the cost of that episode of care is in the post-surgical phase after patients leave the hospital. For […]
The Mobi-C Cervical Disc is now available to more than 200 million insured patients with one-level disc disease and more than 150 million patients with two-level disc disease across more than 90 commercial insurance plans. That makes Mobi-C the most widely covered intervertebral disc for cervical disc replacement in the industry. This “solidifies Zimmer Biomet’s […]
Zimmer Biomet Holdings, Inc. is now the exclusive global distributor of Nextremity Solutions, Inc.’s foot and ankle deformity correction products. An October 20, 2015 announcement from Zimmer Biomet did not disclose financial terms of the agreement but Brad Quick, Zimmer Biomet’s foot and ankle leader, said the deal strengthens their position in the $2 billion […]
Former California state senator Ron Calderon is going to prison for 42 months for his role in the never-ending California Spinal Cap saga. Calderon plead guilty on back in June 2016 to a federal corruption charge and admitting to accepting tens of thousands of dollars in bribes from Michael Drobot, the former owner and CEO […]
Two years after a whistleblower filed a qui tam lawsuit against three California orthopedic clinics for knowingly purchasing deeply discounted viscosupplements that were reimported from foreign countries and billed them to state and federal health care programs, the clinics agreed to pay $2.39 million to settle the cases. On October 3, 2016, the Department of […]
Back in August, we, along with most other media in the U.S., reported on U.S. News & World Report’s 2016-2017 ranking of top orthopedic hospitals in America. Coming in fourth on that ortho list was Rush University Medical Center in Chicago, Illinois. The 677-bed general medical and surgical center was ranked nationally in nine adult […]
A custom device is exempt from 510(k) and Premarket Approval (PMA) submissions because it fits the needs of a particular patient. However, the FDA says under current laws some manufacturers might be unaware that certain devices they distribute as custom devices do not meet the statutory definition and are subject to premarket review. To clarify […]
Our friends at the North American Spine Society (NASS) remind us that the day of negative payment reckoning has arrived for physicians and practices who did not satisfactorily report to the Physician Quality Reporting System (PQRS) in 2015. Center for Medicare and Medicaid Services (CMS) has begun distributing 2017 negative payment adjustment notifications to the […]
German-based joimax GmbH launched two new endoscopic spine products at Eurospine 2016 taking place in Berlin, Germany, from October 5 to October 7, 2016. The two products are the MultiZYTE SI Endoscopic Sacroiliac Joint Therapy Set and the Intracs Intraoperative Navigation Tracking & Control System. The sacroiliac joint therapy set is developed for the treatment […]
Stryker Spine claims its new bone graft material delivery system is truly “advanced” and “simplified”. On October 4, 2016, the company announced the launch of the hand-held LITe BIO Delivery System to deliver bone graft material to spinal surgery sites. Bradley Paddock, president of Stryker’s Spine division, said conventional bone graft delivery methods can accommodate […]
The Federal Trade Commission (FTC) just scored a big victory in its attempt to prevent large healthcare system mergers if the merger reduces competition in a marketplace. In May 2016, the FTC lost its case in a federal district court challenging the Penn State Hershey-PinnacleHealth merger. On September 27, 2016, the U.S. Court of Appeals […]
The 2017 CPT (Currently Procedural Terminology) AMA Codebook contains the first endoscopic spinal surgery code. That’s according to joimax GmbH, a maker of endoscopic equipment, as the company announced the new code in a September 26, 2016 press release. The AMA (American Medical Association) helps the Centers for Medicare and Medicaid Services (CMS) figure out […]
A recent government investigation by Chinese regulators concluded that more than 80% of pharmaceutical clinical data from Chinese studies is “fabricated.” What happens to pharma and regulations has often been a harbinger of what is to come with medical devices. The conclusion also helps explain the U.S. FDA’s caution when accepting data from clinical studies […]
Professor Dr. Govinda KC from the Tribhuvan University Teaching Hospital in Katmandu, Nepal, began his ninth hunger strike.
Medtronic plc actually had good legal news on September 23, 2016, regarding an Infuse lawsuit. Spine patients in Ohio who had back surgery performed by federal fugitive, Atiq Durrani M.D., joined together to sue Medtronic because Durrani used Infuse in an alleged off-label fashion. Durrani is currently practicing back surgery on Pakistanis after fleeing the […]
The FDA is finally taking steps to overhaul its constitutionally flawed off-label prosecutions of device and drug makers by holding a two-day public hearing on November 9 and 10, 2016, to consider, “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.” Multiple federal district courts have held that manufacturers, sales people and physicians […]
K2M Group Holdings, Inc.’s MESA Spinal System has been 510(k) cleared by the FDA for patients under 10 years of age. The clearance, announced on September 21, 2016 at the at the Scoliosis Research Society (SRS) 51st Annual Meeting & Course in Prague, Czech Republic, is good news for children who can now benefit from […]
Want to turn your patients’ CT and MRI scans into 3D simulations? Zimmer Biomet Holdings, Inc. has a new app for that after acquiring a Dutch technology company which developed an app that converts medical scans into 3D motion simulations of a patients’ anatomy. On September 15, 2016, the company announced it acquired Clinical Graphics, […]
Zimmer Biomet Holdings, Inc.’s new Vanguard Individualized Design (ID) knee implant will “revolutionize total knee replacement, ” by “respecting” soft tissue. Todd Davis, the company’s vice president and general manager of global knee business, made the bold prediction in a September 20, 2016 press release announcing the introduction of the implant. Davis says the device […]
The FDA wants to harmonize the agency’s 510(k) third party review submission process with those of other countries participating in the International Medical Device Regulators Forum (IMDRF). On September 12, 2016, the agency issued the “510(k) Third Party Review Program Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations.” Click […]
We don’t mean Zimmer Biomet Holdings, Inc. is moving to Ireland. The orthopedic giant is simply lowering its carbon footprint. The company announced on September 7, 2016, that it’s Warsaw, Indiana-based headquarters is going to be wholly powered by renewable, green energy, in compliance with the U.S. Environmental Protection Agency’s (EPA) Green Power Partnership program. […]
Stryker Corporation is expanding the company’s extremities offerings by buying all the assets of Restore Surgical LLC. Restore Surgical does business as Instratek. Terms of the acquisition were not included in a Stryker announcement on September 14, 2016. Instratek was founded in 1991, is privately held and headquartered in Houston, Texas. The company makes staple […]
Can the use of a pulsed electromagnetic field (PEMF) to treat osteoarthritis (OA) of the knee reduce the need for surgery? Orthofix International N.V. hopes so and has enrolled the first patient in a study evaluating the use of PEMF technology for the first disease-modifying treatment for OA of the knee. The purpose of the […]
Zimmer Biomet Holdings, Inc. is getting a second bite of the apple over a $228 million patent infringement loss to Stryker Corporation. A victory might save Zimmer Biomet over $140 million. On September 12, 2016, Stryker’s $70 million enhanced damage award against Zimmer Biomet in the patent lawsuit was been overturned by a federal appeals […]
Government statisticians using “Big Data” began noticing that some providers were giving lots of tests to the elderly to detect illegal drugs and then billing Medicare. Prosecutors then went after some outliers. On August 31, 2016, one such outlier, Physicians Group Services, P.A., doing business as Coastal Spine and Pain based in Jacksonville, Florida, agreed […]
Randomized clinical trials are the foundation upon which evidence-based medicine, regulatory approvals and payer support is based. But RCT’s didn’t spontaneously appear. The journey to get to the modern RCT started in biblical times and, with the inspiration of a young British soldier in the First World War came fitfully and painfully into existence. Follow the journey here.
The long saga of Regen Biologics, Inc.’s Collagen Meniscus Implant (CMI) seems to have come to a happy ending with a September 1, 2016, announcement that Stryker Corporation’s Endoscopic division had acquired Ivy Sports Medicine, LLC. Ivy Sports Medicine was the institutional investor in ReGen Biologics when the FDA rescinded ReGen’s approval of the company’s […]
Palmetto Health is being sued by the Sisters of Charity Providence Hospitals Legacy Corp. for $50 million. The Sisters of Charity claim Palmetto is responsible for the demise of the orthopedic practice at Providence Hospitals in Columbia, South Carolina. The Sisters of Charity owned Providence at the time of the alleged actions. The Cleveland-based Sisters […]
Blame Baby Boomers and drugs. According to the Congressional Budget Office (CBO), the population is aging so major government healthcare spending will rise by about 6%, or $55 billion in 2016. Prescription Drugs The biggest driver of that 6% increase, says the CBO, is the increased spending per person on prescription drugs. Much of that […]
What is it about foot doctors and healthcare fraud? For the third time in the last couple of years, a podiatrist has pled guilty to defrauding Medicare and other payers. First it was Virginia podiatrist Ilene Terrell, D.P.M., who was sentenced to five months in prison in 2014 for lying to a grand jury about […]
Industry and the FDA have reached a five-year tentative deal on MDUFA IV (Medical Device User Fees Agreement) fees that reaches almost $1billion in fees. On August 22, 2015, the FDA and industry announced the FDA would be authorized to collect $999.5 million in user fees plus adjustments for inflation over five years starting in […]
Effective August 30, 2016, Blue Cross Blue Shield of North Carolina will no longer cover steroid injections for osteoarthritis for the knee. Under a new coverage policy adopted in May, the insurer says intra-articular glucocorticoids for the treatment of individuals who have knee osteoarthritis are considered investigational. The insurer also determined that subacromial glucocorticoids for […]
Jens Chapman, M.D., a University of Washington surgeon, implanted Synthes, Inc.’s Norian bone cement in Reba Goldman’s spine after an accident in 2007. Goldman reportedly died on the operating table. Cindy Wilson, Goldman’s daughter sued Chapman and Synthes, Inc. and four company executives. The company reached a confidential settlement with Wilson during the trial, but […]
In 2012 Zimmer Biomet Holdings, Inc. began partnering with Delaware-based CD Diagnostics to market the Synovasure Periprosthetic Joint Infection (PJI) test. This was the first test specifically designed and validated for the diagnosis of PJI. On August 15, 2016, Zimmer Biomet announced it was acquiring CD Diagnostics. Financial terms were not disclosed. The Musculoskeletal Infection […]
Medicare is going to penalize 2, 597 hospitals by withholding more than half a billion dollars in payments next year. In October 2012, CMS (Centers for Medicare and Medicaid Services) began reducing Medicare payments for Inpatient Prospective Payment System (IPPS) hospitals with excess readmissions. Excess readmissions are measured by a ratio, by dividing a hospital’s […]
Some of the private equity owners that took Biomet, Inc. private in 2007 and then sold Biomet to Zimmer Holdings, Inc. in 2014, are preparing to sell their stake in the new Zimmer Biomet Holdings, Inc. On August 10, 2016, Zimmer Biomet announced the pricing of a secondary offering of 7.4 million shares of its […]
The North American Spine Society (NASS) is calling all spine specialists to political arms. The Society wants you to contact your U.S. House Representative immediately to ask them sign a letter co-authored by Reps. Larry Bucshon, MD (R-IN) and Ami Bera, MD (D-CA) urging CMS to revise the 10- and 90- day global services provision […]
More than 1 million Americans will have their hips or knees replaced in the next year. Which are the best hospitals to perform those procedures. U.S. News and World Report surveyed Medicare data and surgeons to find the top 50 ortho hospitals. Read the rankings here.
UCLA has had a long-running lawsuit involving informed consent and financial disclosures of industry relationships. The university and spine surgeon Jeffrey Wang, M.D. have finally settled the case without admitting any wrongdoing. The court documents tell the story.
There’s another spine society. This new spine society is focusing on endoscopic spine surgery. On July 13, 2016, spine surgeons from Frederick, Maryland-based American Spine announced the formation of the International Society of Endoscopic Spine Surgery (ISESS). The mission behind the new society, according to a press release, is that it would “not be driven […]
Orthopedic surgeons continue to be the goose that lays the golden egg for hospitals. According to Merritt Hawkins’ 2016 Physician Inpatient/Outpatient Revenue Survey that tracks the net revenue that 18 different types of physicians generate on average for their affiliated hospitals, once again, orthopedic surgeons generated the most of any physician group with an annual […]
Orthofix International N.V.’s Trinity Evolution bone graft showed 93.5% fusion rates at 12 months and 78.6% at six months in a 12-month study of patients who underwent single-level anterior cervical discectomy and fusion (ACDF) in combination with a PEEK interbody spacer and supplemental anterior fixation. On July 27, 2016, the company announced the publication of […]
Zimmer Biomet Holdings, Inc. is recalling some Persona Trabecular metal tibial plate instruments and modular brackets. In February 2015, the company initiated a recall of Persona Trabecular Metal Tibial Implants due to incidents of radiolucent lines and loosening higher than Zimmer’s expectations and experience based on Zimmer’s similar devices. At the time, the company said […]
Zimmer Biomet Holdings, Inc. is joining its competitors in helping their customers manage the new Comprehensive Care for Joint Replacement (CJR) and other value-based payment systems. On July 26, 2016, the company unveiled its Signature Solutions program, “a comprehensive suite of clinical services and technologies designed to assist hospitals and medical practices to seamlessly transition […]
Medtronic plc’s spine division launched the Pivox Oblique Lateral Spinal System with Lateral Plate for OLIF25 and Divergence-L Anterior/Oblique Lumbar Fusion System for OLIF51 at the International Meeting on Advanced Spine Techniques (IMAST) in Washington, D.C. Oblique Lateral Interbody Fusion (OLIF) is a surgical technique that the company says minimizes cutting to muscles and “addresses […]
In a growing sign of Medtronic plc flexing its non-spine orthopedics muscle, Shanghai-based Medtronic Kanghui Orthopedics has launched a VariLoc Locking Compression Plate System in China and nine other countries outside the U.S. On July 25, 2016, the company said the angle locking technology allows surgeons to adapt screw angulation to “patient anatomy, capture fracture […]
Invibio was the first provider of PEEK to obtain an FDA Master File. The product was a game changer. According to the FTC, the company then tried to create a monopoly by locking up customers with exclusivity contracts. When competitors tried to enter, they were blocked. The FTC filed a lawsuit. The company agreed to a Consent Decreed. Will the monopoly end?
DePuy Synthes Trauma has a new system to fix hand fractures. The company launched the Variable Angle Locking Hand System on July 19, 2016. The company says the system, which utilizes a proprietary technology, is a “comprehensive and versatile system of anatomically contoured and low-profile plates” to treat hand fractures and correct deformities. It includes […]
Zimmer Biomet Holdings, Inc. is joining Stryker Corporation, Smith & Nephew plc and Medtronic plc in the robotics gold rush. On July 18, 2016, Zimmer Biomet announced it will acquire 59% of a French-based robotic manufacturer, named Medtech SA. ROSA System Medtech, based in Montpellier, France, was founded in 2002 by Bertin Nahum. The company […]
According to 2015 Open Payments data released by the Centers for Medicare & Medicaid Service (CMS), Robert Califf, M.D., the head of the FDA, received five payments from GlaxoSmithKline (GSK) for travel, lodging, food and beverages, as well as a more than $5, 000 consulting fee from AstraZeneca in 2015. In 2014, before going to […]
Wow. The first week of July was a big week for FDA approvals for orthopedic devices. On July 5, 2016, the FDA granted Premarket Approval (PMA) for the Cartiva, Inc.’s Synthetic Cartilage Implant (SCI) for arthritis of the big toe joint. The implant is the first synthetic cartilage device approved by the FDA. The FDA’s […]
On July 5, 2016, a $650 million verdict against DePuy Synthes over its metal-on-metal Pinnacle hip implant was slashed by $500 million by a Texas federal judge. However, the U.S. District Judge Ed Kinkeade, ruled a day later that a September trial in the ongoing multidistrict litigation will proceed. The judge said that he was […]
In 2014, the FDA granted premarket application (PMA) approval to Medtronic plc’s Prestige LP cervical disc for single level use. On July 7, 2016, the agency granted PMA approval for the same device, but for two-level use. The Prestige LP is the second cervical disc to receive approval for two-level cervical disc replacement (CDR) behind […]
False Claims Act (FCA) penalties may be about to double. On November 2, 2015, President Obama signed into law the Bipartisan Budget Act of 2015 which requires, among other things, that federal agencies significantly increase civil monetary penalties, including those awardable under the FCA. The Department of Justice (DOJ) published an Interim Final Rule on […]
There is a huge backlog of pending appeals for Medicare reimbursements. By the end of 2015, according to the government, there were a total of 898, 891 pending appeals, which would take about 11 years for the Office of Medicare Hearings and Appeals (OMHA) and 6 years for the Medicare Appeals Council (MAC) to process. […]
NuVasive, Inc. and Medtronic plc have made peace. On June 30, 2016, NuVasive announced that the company has agreed to settle ongoing patent litigation with Medtronic by paying Medtronic $45 million to settle litigation that began in 2008 in federal court in California. The litigation led to a jury verdict finding both companies liable for […]
Two former California politicians have pleaded guilty to bribery charges and joined nine others who have pleaded guilty in the massive Worker’s Comp criminal billing scheme that cost insurers over $600 million. The scorecard keeps growing. More to come?
Zimmer Biomet Holdings, Inc. is launching enhancements to its OSS Orthopedic Salvage System, “a comprehensive set of joint reconstruction prostheses designed to treat patients suffering from bone loss due to tumor resection, ligamentous deficiencies, orthopaedic trauma or patients who have undergone multiple knee and hip revision arthroplasties.” A June 16, 2016 announcement of the global […]
On June 22, 2016, the U.S. Department of Justice (DOJ) completed the “largest takedown ever” against defendants allegedly defrauding Medicare and other federal insurance programs. The DOJ filed criminal and civil charges against 301 individuals, including 61 doctors, nurses and other licensed medical professionals, for their alleged participation in health care fraud schemes involving approximately […]
Last October, the U.S. Department of Justice arrested Carl Reichel, a former president of Warner Chilcott, for violating the Anti-Kickback Statute over the company’s osteoporosis drugs, Actonel and Atelvia. On June 17, 2016, a federal jury acquitted Reichel on charges that he bribed physicians with pricey meals and speaking fees to induce them to write […]
When the FDA Ortho Panel meets, the panel is not only asked to advise on safety and effectiveness, but also on whether or not the benefits of a new device outweigh the risks to patients. On June 16, 2016, the agency issued a draft guidance titled, Factors to Consider Regarding Benefit-Risk in Medical Device Product […]
One of the hedge fund managers charged recently in an FDA insider trading scandal has reportedly committed suicide. Reuters reported on June 21, 2016 that Visium Asset Management LP fund manager, Sanjay Valvani was found dead by his wife on June 20 at their Brooklyn home with a wound to his neck. A suicide note […]
The federal government and a giant healthcare system are preparing to square off over the issue of “Steering and Tiering.” The government says Carolinas Healthcare System, due to its dominant market share, is keeping prices high and competitors down. The big guns are out on this one.
The FDA regulates billions of dollars of the U.S. economy. The agency’s pending decisions about approvals and clearances are closely guarded. If leaked, investors and competitors can gain or lose huge advantages, or worse, public health is impacted. Most of the time the secrecy works. But a recent prosecution of a former deputy director of […]
When Zimmer Holdings, Inc. purchased Biomet, Inc., Zimmer management was well aware that Biomet was under the cloud of a 2012 deferred prosecution agreement (DPA) with U.S. Justice Department to resolve a foreign corruption investigation (FCPA). The DPA was extended for successive years as prosecutors continued to investigate Biomet’s conduct. Now that cloud has gotten […]
Changes in commercial insurance policies in North Carolina to restrict lumbar fusion surgeries for certain indications resulted in a sharp reduction of elective lumbar fusion surgeries in that state. That’s the conclusion of a recent study published in Spine (June 2016 – Volume 41 – Issue 11 – p. 647–655). North Carolina has been ground […]
The FDA has sent Zimmer Biomet Holdings, Inc. a Warning Letter “related to observed non-conformities with current good manufacturing practice requirements of the Quality System regulation at the Company’s facility in Montreal, Quebec, Canada, ” according to a company June 6, 2016 8-K SEC filing. The filing states the FDA inspected the facility in January […]
Physician-owned Humble Surgical Hospital, a multi-specialty surgical center (including spine and orthopedics, ) opened in August 2010 in the north Houston area. The physicians immediately began submitting claims for reimbursement to Cigna Health Insurance. Cigna paid the hospital’s claims for a few months based on negotiated agreements between the hospital and MultiPlan, Inc. or Viant […]
Novel medical devices declared safe and effective by the FDA can take up to three years before receiving Centers for Medicare and Medicaid (CMS) coverage and reimbursement. That’s a long time for elderly Medicare patients to wait for potential life-saving medical care. The U.S. Senator from the “Orthopedic Capitol of the World” wants to change […]
Five years after putting out a draft guidance, the FDA issued a final Postmarket Surveillance Section 522 guidance document on May 16, 2016. Congress first granted the FDA authority to require manufacturers to conduct postmarket surveillance under section 522 of the Safe Medical Devices Act of 1990. For example, we’ve seen the agency exercise this […]
Zimmer Biomet Holdings, Inc. is acquiring Austin-based LDR Holding Corporation for $1 billion. The announcement on June 7, 2016 sent Wall Street analysts to their keyboards to write that this acquisition may signal the beginning of consolidation in spine. Zimmer Biomet’s offer, approved by both boards, calls for Zimmer Biomet to acquire all the outstanding […]
MDUFA IV is coming your way in 2017. It may cost you more money and calls for real-world evidence (RWE). MDUFA stands for the Medical Device User Fee Act. MDUFA comprises a substantial part of the FDA’s budget to review, clear or approve applications from industry to bring new devices to market. Negotiations take place […]
Medtronic plc wants to differentiate itself by making 1- and 2-level cervical spinal fusions less expensive for hospitals. To reach that goal, the company is launching Spine Essentials, a new platform of spinal implants and instruments, which the company says will make cervical spine fusion procedures “more efficient and help hospital systems manage costs, while […]
The biggest health care and printer companies in the world are now collaborating to create new 3D medical devices and other health care solutions. On May 17, 2016, Johnson & Johnson, parent company of DePuy Synthes, and HP Inc. announced the collaboration to develop 3D printing technologies to “create better health care outcomes at reduced […]
PODs (physician-owned distributors) are spreading. The U.S. Senate and the device industry continue to try to kill them off. The latest attack from the U.S. Senate found an unexpected ally—leaders of the POD movement. Read about the latest battle in this ongoing war.
Orthofix International N.V. is bringing the first interbody spacer system to the spine market which combines PEEK and 3D-printed titanium end plates into a single porous interbody solution for lumbar spine fusion procedures. On May 16, 2016, the company announced the Forza PTC (PEEK Titanium Composite) Spacer System has received FDA 510(k) clearance and will […]
While health insurers are reporting losing their shirts on the Obamacare insurance exchanges, their Medicare Advantage plans have over-billed the government by billions of dollars, and have rarely been forced to repay the money or face other consequences for their actions, according to a new Congressional audit by the Government Accountability Office (GAO). In a […]
DePuy Orthopaedics, Inc. is beefing up its small bones business in a challenged trauma market. On May 9, 2016, the company, part of the DePuy Synthes Companies, announced the acquisition of privately held BioMedical Enterprises, Inc. (BME). BME manufactures nitinol orthopedic implants for small bone fixation. The implants are used to treat bunions, hammertoes and […]
The “Bluebloods” of orthopedics can navigate the potential dangers of an FDA panel review meeting with minimum risk. But when a “Minnow” faces the FDA’s experts, the risks can be fatal. Tim Patrick of Cartiva, Inc. tells us how his company handled the pressure.
Camber Spine Technologies has launched Prolix and Orthros MIS spine systems. In a May 9, 2016 announcement, the company says it believes its Prolix SI fusion system is the “first true fusion product designed to treat Sacro-Iliac pain.” The system, according to the company, utilizes a “safe inferior approach between the posterior superior iliac spine […]
May might be the month that the FDA finally issues new rules that allow the agency to accept data from clinical studies outside the U.S. The FDA is scheduled to release three new finalized regulations this month dealing with medical device trial data, postmarket safety reporting requirements for combination products, and revised regulation on what […]
Medtronic plc’s Prestige LP Cervical Disc has “demonstrated greater rates of overall success compared to 2-level ACDF [anterior cervical discectomy and fusion] patients, ” reported Todd Lanman, M.D., at the 84th Annual Meeting of the American Association of Neurological Surgeons (AANS) in Chicago. In a May 3, 2016 Medtronic press release, the company announced results […]
If you’re in the business or profession of addressing pain, you’ve got the attention of the new FDA Commissioner, Robert Califf, M.D. On March 30, 2016, Califf wrote in his first agency blog posting that the agency has an overarching “clear, realistic, and focused sense of priorities, ” with pain and the “present epidemic of […]
There’s a case (Universal Health Services v Escobar) before the U.S. Supreme Court which may limit the reasons whistleblowers can use to file a False Claims lawsuits. “Implied Certification Theory” Currently, whistleblowers can file a False Claims lawsuit even when the payment request contains no false information. This is called the “implied certification theory.” The […]
Stryker Corporation introduced JointCOACH at its 9th Annual Orthopedic & Spine Summit in Chicago on April 27, 2016. With this introduction, Stryker is attempting to help hospitals across the country navigate Medicare’s new five-year Comprehensive Care for Joint Replacement (CJR) payment model for hip and knee replacements that holds them financially responsible for the total […]
The U.S., the European Union (EU) and Japan have won a trade battle with China. The Chinese government had a policy that unfairly benefited over 100 Chinese medical technology firms over their foreign counterparts with an export duty that added as much as 300% to the costs on rare earths, tungstens and molybdenum products used […]
Neil Van Dyck, DPM was a California-licensed podiatrist who operated a podiatry practice in Roseville called Placer Podiatry. There, he offered “spa-like” treatments and performed routine foot care. Van Dyck is about to go to a different kind of spa. On April 15, 2016, U.S. District Judge Garland E. Burrell Jr. sentenced Van Dyck to […]
Surgeons were supposed to be in danger of becoming “Widgets for WellPoint.” But the march towards surgeons working for payers didn’t turn out as expected. Unintended consequences and raw surgeon creativity forged new strategies to put physicians back in control. Read where we sit today.
Just as its CEO, Stephen Hemsley warned at the end of 2015, UnitedHealth Group Inc., the nation’s largest private insurer is planning to dump most of its Obamacare individual insurance plans in 2017. The insurer has been selling its plans in 34 states this year, up from 25 states last year. The company has 795, […]
Warsaw, Indiana, the self-described capital of the orthopedic world, does not want to stand still and promises to help its entrepreneurs speed up their innovation process. On April 5, 2016, OrthoWorx, the area’s orthopedic economic development promoter, announced the formation of AcceLinx, an organization that will leverage “the unique assets of the Northern Indiana orthopedic […]
Eleven years ago, Jeffrey Bierman, a medical billing contractor from Missouri, filed a federal whistleblower lawsuit on behalf of the U.S. in federal courts in Massachusetts, accusing bone-growth stimulator manufacturers of both civil and criminal false claims. Bierman alleged that makers of the devices defrauded Medicare by selling, instead of renting the devices and coaching […]
The U.S. Senate and House of Representatives are close to agreeing on a bipartisan package of bills called the 21st Century Cures bill. The House passed the bill on a 344 to 77 vote and the Senate Health, Education, Labor & Pension Committee has advanced five more bill as part of a series of 19 […]
Stryker Corporation’s Spine division has acquired the product portfolio of SafeWire, LLC. The SafeWire products are used in minimally invasive procedures using Stryker’s percutaneous ES2 spinal fixation system & LITe (less invasive technologies) procedure solutions. Products including the Y-Wire guidewire and Tiger Jamshidi Needle Family. An April 11, 2016 announcement stated that the Y-Wire has […]
The FDA has granted additional indications to K2M Holdings, Inc. to treat the cervical spine. On April 6, 2016, the company announced that it received 510(k) clearance from the FDA to expand indications of its Mesa and Denali Mini Spinal Systems. The systems function as adjuncts to fusion, providing stabilization of the posterior cervical and […]
As Wells Fargo senior analyst Larry Biegelsen reported at the end of March, FDA PMA (pre-market approval) performance is at an all-time high for approvals and speed of reviews. But in an April 8, 2016 report, Biegelsen and his team found that the agency’s performance with 510(k) clearance trends isn’t quite as good. Less expensive […]
Two orthopedic companies, Arthrex Inc. and Xtant Medical Holdings, Inc. signed distribution agreements with Vivex Biomedical, Inc. in March to give them access to the biomedical company’s proprietary line of biologics. The March 31, 2016 agreement with Arthrex, “significantly” expands the breadth of Vivex Biomedical products available through Arthrex. The March 24 agreement between Xtant […]
At the end of 2015, the FDA proposed a plan for notifying the public about medical device “emerging signals.” An emerging signal, stated the proposal, is new information about a medical device used in clinical practice: that the agency is monitoring or analyzing, that has the potential to impact patient management decisions and/or alter the […]
In an effort to harmonize the dual goals of protecting and promoting public health, the FDA wants to expedite the generation and dissemination of reliable device data, including real-world evidence. To accomplish this, the agency and the Brookings Center for Health Policy convened a planning board in 2014 made up of patients, clinicians, researchers, provider […]
The FDA is proposing to classify posterior cervical screw systems into class II (special controls) and to continue to require premarket notification to provide a reasonable assurance of safety and effectiveness of the device. You’ve got until June 8, 2016 to tell them what you think about that. A posterior cervical screw system is a […]
Donald Trump wants to repeal and replace Obamacare. “We have to take care of the people in our country. We can’t let them die on the sidewalks of New York or the sidewalks of Iowa or anywhere else.” Sounds good. Except his plan costs the public purse almost $500 billion over ten years and removes over 20 million people from insurance coverage. What’s in the plan? Read it here.
The FDA approved more pre-market approval (PMA) applications during 2015 than any year since 2001. In 2015, according to a March 23, 2016 note from Wells Fargo analyst Larry Biegelsen, 43 original PMAs were approved during the year. That’s more than the 25 approved in 2014 and more than double the approvals in 2013. Device […]
A 2012 deferred prosecution agreement (DPA) between the U.S. Department of Justice (DOJ), the Securities and Exchange Commission (SEC) and Biomet, Inc., was due to expire on March 26, 2016. However, a March 25 8-K filing from Zimmer Biomet Holdings, Inc., said the DPA would continue past that deadline. When Zimmer Holdings, Inc. bought Biomet, […]
The FDA’s panel of spine orthopedic experts roundly voted against recommending approval for Medtronic’s DIAM Spinal Stabilization System. But Medtronic is not giving up. Read what happened at the panel meeting and how Medtronic is responding.
The second round between DePuy Synthes and patients implanted with the company’s metal-on-metal hip, the Pinnacle, has gone to the plaintiffs. Each side has now won a federal court victory. On March 17, 2016, following a two-month trial and one week of deliberation, a jury found that the hips were defectively designed, and that the […]
England’s junior doctors went on strike for the third time on March 8, 2016, after talks over new contracts between the government and the doctor’s trade union, the British Medical Association, broke down. Junior doctors have received their medical degrees. The government had announced plans to impose a new contract on the junior doctors this […]
Game, set and match. The FDA has thrown in the Amarin towel and will not appeal a federal court ruling that Amarin Pharma, Inc. has the First Amendment right to tell physicians about off-label uses for their fish oil product, if the claims are “truthful and non-misleading.” Medical device makers now have a clear roadmap […]
Zimmer Biomet Holdings, Inc. finished its coming out party at the American Academy of Orthopaedic Surgeons (AAOS) annual meeting with announcements of a deal to distribute CelgenTek Innovations Corp’s bone trauma technology and launches of the Persona Medial Congruent Bearing and OsseoTi Tibial Sleeves for the Vanguard 360 Revision Knee System. CelgenTek Innovations Distribution Agreement […]
The FDA’s Orthopaedic and Rehabilitation Devices Panel will meet on April 20, 2016 to discuss, make recommendations, and vote on the premarket approval application (PMA) for the Cartiva Synthetic Cartilage Implant (SCI), sponsored by Cartiva, Inc. Cartiva’s implant is an organic polymer-based biomaterial to mimic biologic cartilage. The device, according to an FDA announcement, is […]
DePuy Synthes is jumping on the “bundled payment” train by entering into an exclusive alliance with Value Stream Partners, a company specializing in knee and hip replacement bundled payment program development and implementation. On March 2, 2016, Juan-Jose Gonzales, the president of DePuy Synthes said the company is focused on innovation and offering total solutions […]
Zimmer Biomet Holdings, Inc. has launched three new hip portfolio products which promise to conserve natural bone, add new sizes and offer the benefit of dislocation resistance. The products, announced on March 2, 2016, are the Echo Bi-Metric Microplasty stem femoral prosthesis, the G7 Dual Mobility Construct and the Arcos One-Piece Femoral. Echo Bi-Metric Microplasty […]
Stryker Corporation’s spine division launched the Xia 4.5 Cortical Trajectory implants and instruments at the American Academy of Orthopaedic Surgeon’s annual meeting in Orlando, Florida on March 2, 2016. Two days later the company announced FDA 510(k) clearance of its Tritanium PL Posterior Lumbar Cage. The company says Xia 4.5 implants and instruments facilitate a […]
The U.S. Senate finally confirmed cardiologist Robert Califf, M.D. as the permanent FDA Commissioner. His tenure may be short-lived as a new president takes over in 2017 and will likely nominate his or her own agency head. Senators voted 89-4 to give him the job. The four senators who voted against the nomination, Republican Kelly […]
After a 13-day trial and 5 hours of deliberation, a federal jury in California found that NuVasive, Inc. breached its contract with a Nevada-based distributor named Madsen Medical. The finding on February 19, 2016 was followed four days later by the jury awarding $41.8 million to Madsen Medical and its owner Kris Madsen. According to […]
Hospitals and surgeons want Congress to build a bigger safe harbor to protect them from lawyers suing them for violations of the Stark Law. New payment models pushing hospitals and physicians to collaborate, may run afoul of the Stark Law written in a bygone economic time. Read what they want the new harbor to look like.
Washington insider Scott Whitaker has been named as the new president and CEO of the Advanced Medical Technology Association.
A recent study in the Journal of the Royal Society of Medicine posits that Michelangelo Buonarroti suffered from osteoarthritis that left his hands “gnarled and aching, ” in his old age. The diagnosis comes from of a group of medical researchers who analyzed the depiction of his left hand in three portraits from different points […]
England’s junior doctors made good on their threat and struck for the second time on February 10, 2016. The junior doctors, who work for the National Health Service (NHS) went on a one-day strike on January 12, 2016 to protest a new employment contract offered by the government. The physicians provided only emergency care during […]
“Don’t worry, ” says one Wall Street analyst to hip and knee makers about Medicare’s new joint replacement payment model. The CJR payment model kicks in on April Fool’s Day and hospitals will be holding the risk bag over surgical outcomes. Will device makers share in the risk? Probably not. Here’s why.
On Thursday, February 11, 2016, the Centers for Medicare and Medicaid Services (CMS) issued a final rule dealing with the return of overpayments made to providers. According to the agency, the major provisions of this final rule include clarifications around: “the meaning of overpayment identification; the required lookback period for overpayment identification; and the methods […]
FDA (510) clearances, by definition, are not usually considered “ground-breaking.” Such lofty language is usually saved for the rare FDA PMA (premarket approval) approved product. But Zimmer Biomet Holdings, Inc., used such language on February 11, 2016, to describe its recently FDA cleared foot and ankle joint fusion system, called the Unite3D Bridge Fixation System. […]
Almost 1, 000 healthcare providers in the Philadelphia area have formed a clinically integrated partnership with NueHealth to “connect them to healthcare consumers across the region, providing value-based payment options and improved outcomes alongside an improved model for healthcare delivery.” NueHealth is a privately held organization specializing in clinically integrated provider networks (IPNs), custom benefit […]
Efforts to develop genetic diagnostics for spinal diseases received a boost as Predictive Therapeutics, a subsidiary of Predictive Technology Group, Inc. (PRED) of Salt Lake City, Utah, announced a favorable ruling from the U.S. Patent and Trademark Office’s Patent and Appeal Board (PTAB) for its spine deformity test. The company uses gene-based information to develop […]
Rack one up in the win column for a metal-on-metal hip manufacturer. On February 3, 2016, Corin Group PLC and Corin USA Limited (Corin) prevailed in a lawsuit alleging injuries from Corin’s hip resurfacing system, the Cormet, a Class III medical device approved by the U.S. Food and Drug Administration (Swisher v. Stryker Corporation, et […]
Last November, UnitedHealth Group’s CEO Stephen Hemsley said his company was losing money on subscribers signed up through the Affordable Care Act’s (ACA) healthcare insurance exchanges. He said the company made a mistake by participating in the exchanges before fully understanding the financial risks. Now, Mark Bertolini, the chairman of Aetna, says his company’s insurance […]
Bill Jellison is retiring as Stryker Corporation’s chief financial officer. He will be replaced from within by Glenn Boehnlein.
The non-partisan Congressional Budget Office (CBO) reported on January 25, 2016, that fewer people than expected are taking advantage of subsidies to purchase health insurance under the Affordable Care Act (ACA). The CBO study, based on updated enrollment figures up through last month, says that 11 million people are likely to purchase subsidized policies under […]
The European Union has granted CE Mark to K2M Group Holdings, Inc. for its Rhine cervical disc system. According to a January 21, 2016 announcement, the disc is the company’s next-generation cervical artificial disc replacement featuring proprietary molding technology and is the company’s latest offering for the treatment of degenerative disc disease. The disc system […]
VertiFlex, Inc. has raised nearly $27 million for its FDA-approved (May 2015) Superion Interspinous Spacer (ISS). According to a Security and Exchange Commission regulatory filing, the funding consists of $10.5 million in new cash, a $16.2 million debt conversion and another $105, 000 in warrants. Eight unnamed investors participated in the funding. The Superion Spacer, […]
On December 15, 2015, Spine published Aesculap Implant Systems, LLC’s 24-month primary endpoint outcomes of its activL artificial disc in comparison to predicate lumbar total disc replacement designs. The paper, “Lumbar Total Disc Replacement for Discogenic Low Back Pain: Two-year Outcomes of the activL Multicenter Randomized Controlled IDE Clinical Trial, ” by Garcia, R. Jr., […]
On January 12, 2016, the U.S. District Court in Trenton, New Jersey, ruled in favor of KFx Medical Corporation in a lawsuit filed by Arthrex Incorporated on July 31, 2015. The two companies have been involved in an ongoing patent infringement dispute. According to a January 19, 2016 KFx press release, Arthrex sued KFx and […]
Johnson & Johnson is going to lay-off 3, 000 employees in its medical device business division. It’s been almost five years since Johnson & Johnson paid $21.3 billion to acquire Synthes and made Michel Orsinger, the former CEO of Synthes, the head of the merged company’s DePuy Synthes orthopedics business. The merger, admitted company officials, […]
Is yoga an effective way to treat osteoporosis and osteopenia? Standard of care for treating osteoporosis includes exercise—like yoga. A new study attempts to quantify how exercise—specifically yoga—affect bone mass. Loren Fishman, M.D. was principal investigator and his results are summarized here.
English junior doctors, who work for the National Health Service (NHS) went on a one-day strike on January 12, 2016 to protest a new employment contract offered by the government. While unheard of the in the U.S., physicians in Europe will take to the picket lines. German physicians went on strike in 2006 and 2010. […]
Benvenue Medical, Inc. announced on January 6, 2016 that is has completed a $60 million round of financing. The spine company said it will use the funds to accelerate U.S. commercialization activities for its two minimally invasive products—the Luna 3D Interbody Fusion System for treating degenerative disc disease and the Kiva VCF Treatment System for […]
Austin, Texas-based Ortho Kinematics‚ Inc., has raised another $4 million in debt financing to expand commercialization of the company’s VMA (Vertebral Motion Analysis), a machine which performs diagnostic radiographic assessments of spinal motion instability. Last April the company announced the close of $9.6 million in Series C equity financing. The debt financing was completed amongst […]
K2M Group Holdings, Inc. has received FDA 510(k) clearance to market Cascadia, its third lateral interbody system featuring the company’s Lamellar Titanium Technology. The company also received FDA 510(k) clearance and a CE Mark for the Cascadia AN and TL interbody systems in 2015. Lamellar Titanium Technology Lamellar titanium technology is the company’s proprietary technology […]
Our readers have spoken. Industry consolidation, new technologies, changing surgeon and sales rep roles, fixing pain, ongoing financial corruption and the passing of a giant topped the list of stories our readers picked as the most important things to remember from 2015.
The FDA intends to publish a number of guidance documents in 2016. The agency also wants to hear from you regarding whether or not previously issued final guidances should be revised or withdrawn. On December 28, 2015, the agency provided three lists for comment. “A-List” The “A-List” contains guidance documents the agency fully intends to […]
The FDA has decided that a knee replacement surgical guide system using only X-rays is not substantially equivalent (NSE) to systems that use MRI or CT. On December 22, 2015, Belgian-based Materialise NV announced receipt of an FDA NSE letter after the company submitted a 510(k) application to market its product in the U.S. After […]
Lima Corporate SpA ownership is changing hands from one private equity firm to another. On December 23, 2015, the Italian company announced that private equity firm EQT acquired the majority of the company’s shares. The deal is still subject to regulatory approval in European jurisdiction. Lima picked up some of the spoils of the divestiture […]
There is a common narrative that device and drug companies sometimes fudge on reporting results from their clinical trials. Two cases, Medtronic plc and DePuy Synthes, come to mind over allegations the companies failed to report problems with Infuse and metal-on-metal hips. But a December 13, 2015 Statnews.com (Stat) investigation reported by the Association of […]
The OrthoNOW orthopedic urgent care center franchise is expanding. On December 21, 2015, the company announced plans to open eight new locations throughout Florida in Aventura, Pinecrest, Winter Park, Wellington and two locations in Miami (Biscayne Blvd. and Coral Way), as well as two locations in Georgia (Savannah and Pooler). Alejandro Badia, M.D., FACS, the […]
Knoxville, Tennessee-based ChoiceSpine, LP has received FDA 510(k) clearance to sell its Tomcat stand-alone cervical device. A December 21, 2015 announcement from the company said the new device, “molds the benefits and functionality of two other ChoiceSpine products, Stealth and Falcon, into one while it expands innovation as one of the first stand-alone cervical devices […]
Allegations that hospitals kept kyphoplasty patients overnight, instead of on an outpatient basis, continues to serve as an ATM for the government. On December 18, 2015, the U.S. Department of Justice announced that 32 more hospitals will pay the government $28 million to settle charges that they submitted false claims to Medicare for inpatient stays […]
The FDA has granted clearance to the world’s smallest wireless eight-electrode spinal cord stimulator (SCS) system. The agency granted clearance to a four-electrode device last year made by the same company. On December 9, 2015, Stimwave Technologies Inc. announced FDA clearance of its Stimwave Freedom-8A SCS system. The company says its system is the world’s […]
The FDA says multiple injections of Gel-One Cross-linked Hyaluronate, made by Zimmer Biomet Holdings, Inc., are safe. The early December expanded safety announcement by the company said the FDA agreed the single-injection product is safe for use in repeat treatments administered in the physician office setting. Gel-One, according to the company, is indicated for knee […]
K2M Group Holdings, Inc. announced on December 16, 2015 it has received FDA clearance and CE Mark to market the Everest Minimally Invasive XT Spinal System, the company’s newest addition to its Everest family of products. The system is a cannulated top-loading pedicle screw system featuring rigid closed-top break-off extension tabs for minimally invasive rod […]
The FDA has given up its attempt to limit Pacira Pharmaceuticals Inc.’s promotion of its pain drug, Exparel. The company wanted a supplement to their label that showed the drug was not limited to a specific surgery. The FDA threatened Pacira with a warning in 2014 over the company’s promotional materials. The agency said those […]
Medtronic plc’s Infuse bone graft has been granted Supplemental FDA Approval for three additional spine surgery indications. The company expects to begin marketing the expanded indications in early calendar year 2016. With this expanded approval, the company said on December 11, 2015, that it will be able to market the bone graft for use with […]
On December 3, 2015, Medtronic plc’s spinal division reported another quarter of flat revenue with sales of $719 million. Overall, the company reported a 6% rise in sales, while the company’s Restorative Therapies Group (RTG) rose 5%. The company’s other divisions had analysts swooning over results. The company generated $1.1 billion in free cash flow […]
The head of America’s largest insurance company dropped a bombshell recently when he said his company can’t make money on insurance policies offered through Obamacare exchanges. After failed political and constitutional challenges to the Affordable Care Act, the marketplace is finally having the final word. Read it here.
Another metal-on-metal hip maker has lost a bellwether trial in a federal court. After a two week trial, a federal jury in Atlanta awarded $11 million to Robyn Christiansen, a retired ski instructor implanted with an allegedly defective metal-on-metal hip implant made by Wright Medical Technology, Inc. The jury, according to the Atlanta Journal-Constitution, deliberated […]
A federal judge in Michigan ruled on November 19, 2015 that a former New Orleans sales rep for Stryker Corporation must face the music of breach of contract and breach of fiduciary duty charges. Christopher Ridgeway, the former rep, tried to make a technical argument that he worked for Stryker Leibinger, not Howmedica Osteonics, a […]
The FDA’s Orthopaedic and Rehabilitation Devices Committee is going to meet on February 19, 2016 to consider Medtronic plc’s premarket application for its DIAM Spinal Stabilization System. DIAM Indications According to the FDA, the system is indicated for “skeletally mature patients that have low back pain (with or without radicular pain) with current episode lasting […]
Arthrex, Inc. is suing ArthroCare Corp. and its parent, Smith & Nephew plc, for the second time over certain patent infringement claims. The first time Arthrex sued over these patents was this past June. That suit alleged 47 counts of infringement related to 12 Arthrex patents. The new suit brings the total to 49 counts […]
Nexxt Spine, LLC launched its DT Elite Guide System on November 17, 2015. The company claims the guides reduce the number of operative steps during an anterior cervical discectomy and fusion (ACDF) procedure because the surgeon can determine the appropriate interbody dimensions and prepare screw pilot holes for the anterior plate simultaneously. The system, according […]
Patient information can be a powerful competitive advantage between providers fighting over those patients. On October 6, 2015, the Office of Inspector General (OIG) issued a new alert to make sure providers don’t abuse that information and run afoul of the Anti-Kickback Statute (AKS). The government has spent billions of dollars to promote the adoption […]
The two largest spine societies have agreed. Payers should pay for 2-Level Cervical Disc Replacement surgeries. Is that enough to get insurance companies to pony up? This will be a test of spine society power.
In July 2015, the Centers for Medicare and Medicaid Services (CMS) proposed the Comprehensive Care for Joint Replacement (CJR) model. After reviewing nearly 400 comments from the public, the agency published the final rule on November 17, 2015. Several major changes were made from the proposed rule, including the model start date to April Fool’s […]
It’s hard to kill a good idea. Even for the FDA. On November 12, 2015, Ivy Sports Medicine, LLC announced the first implantation of its Collagen Meniscus Implant (CMI) in the U.S. The surgery was performed by Wayne Gersoff, M.D. in Denver, Colorado. Rescission Battle Readers may remember that Ivy Sports was an institutional investor […]
The FDA has granted clearance to Prosidyan, Inc.’s fiber-based bioactive glass products for use in postero-lateral fusion. The company’s Fibergraft BG Morsels, ultra-porous bone graft substitutes, are made entirely from 45S5 bioactive glass microfibers and microspheres. Hyun Bae, M.D., is the company’s chief medical officer. In a November 16, 2015 announcement Bae said the product […]
The Department of Justice (DOJ) recently announced the arrests of Rita Luthra, M.D., and W. Carl Reichel, a former drug company president for violating the Anti-Kickback Statute over the company’s osteoporosis drugs, Actonel and Atelvia. The company, Warner Chilcott also agreed to plead guilty to healthcare fraud in Massachusetts and pay the government $125 million […]
While justice is delayed and, therefore, denied to patients in Ohio who were allegedly harmed by the Pakistani fugitive spine surgeon, Atiq Durrani, M.D., the government is getting its justice as the hospital where Durrani plied his mayhem, has agreed to pay $4.1 million to settle allegations that the hospital violated the False Claims Act […]
It’s been a long, long time since the FDA gave their PMA (Premarket Approval) application blessing to bone graft for the spine. But on November 3, 2015, Cerapedics, Inc. announced the agency approved their i-Factor Peptide Enhance Bone Graft for use in anterior cervical discectomy and fusion (ACDF) procedures in patients with degenerative disc disease. […]
France-based Medtech S.A., has obtained a $15 million commitment to develop its ROSA Brain and ROSA Spine surgical assistance robots. ROSA Spine is a robotic assistive device for minimally invasive spine surgery. The company announced on November 2, 2015 that Ally Bridge Group, a global healthcare-focused investment group made the commitment through the purchase of […]
Want your complaint system to be FDA compliant? There’s an app for that with a new cloud-based system to allow medical device companies to process paperless and compliant complaints required by FDA regulations. San Francisco-based FastQS announced the launch of its Complaint Management Solutions program on November 4, 2015. Most device companies use a highly […]
Patients return to work faster after being implanted with Medtronic plc’s Prestige LP Cervical Disc than when they had a fusion, according to new seven-year data. Matthew Gornet, M.D., an orthopedic surgeon at the Orthopedic Center in St. Louis, Missouri, presented the data at the recently completed North American Spine Society meeting in Chicago, Illinois. […]
DePuy Synthes Spine has a new all-in-one pedicle screw system called the Expedium Verse Spinal System. By potentially reducing the number of screws needed in a procedure, the company claims the Expedium system allows surgeons to perform multiple maneuvers during fusion surgery with a single implant type and fewer instruments. The system touts an innovative […]
The U.S. Department of Justice has arrested a physician and former president of a drug maker for violating the Anti-Kickback Statute over the company’s osteoporosis drugs, Actonel and Atelvia. Rita Luthra, M.D. was arrested on October 22, 2015, for allegedly accepting free meals and speaker fees from the drug maker, Warner Chilcott, in return for […]
Two recently retracted papers in the Journal of Neurosurgery (JNS) point to the dangers of trying to guess what amount of overlap the publication is willing to tolerate. Two papers published in JNS in 2010 and 2013 dealing with stem cells in bone marrow and the sciatic nerve have been retracted after accusations of plagiarism […]
The Centers for Medicare and Medicaid Services’s (CMS) 2016 physician fee schedule reads more like an algorithm about how physicians will be paid in the future than a simple update of how much more money the agency will pay for services in the coming year. While there is an overall increase of 0.5% for all […]
The business of healthcare keeps changing. Physicians find themselves in the middle of health systems and payers who are getting bigger and exercising more power over their clinical decisions. As recent actions by some orthopedists show, not all surgeons are on board. One even filed a whistleblower lawsuit—and won!
Surgeons are political conservatives? Their campaign contributions go overwhelmingly to Republicans. Not so for their general medicine colleagues. Why is that? We found 16 peer-reviewed studies about the physiological differences between liberals and conservatives from the folks at ProCon.org. Where do you fit?
Investors and the orthopedics industry have been holding their collective breaths waiting to see how the Zimmer Biomet Holdings, Inc. merger is going to work out. Revenue Rises On October 29, 2015, company President and CEO Dave Dvorak put fears to rest. He announced that in the first quarter as a combined company, revenue, on […]
Patients treated with Trinity Evolution, Orthofix International N.V.’s cellular bone allograft (CBA), demonstrated foot and ankle fusion rates of over 86% at 12 months after follow-up. In the largest such study of the allograft to date, and published in Foot & Ankle International, the investigators also reported that the successful fusion significantly correlated with improvements […]
Stryker Corporation and Zimmer Biomet Holdings, Inc. are heading to the U.S. Supreme Court over a patent damage award that may have far reaching consequences on the size of patent awards based on “willful infringement.” Stryker Sued Zimmer Back in 2010 Stryker sued Zimmer over a portable lavage device that Zimmer manufactured to replace its […]
Stryker Corporation’s orthopedics business grew by 5.8% on a constant currency basis, reaching $1.019 billion in the third quarter. Knees and hips were up over 3%, while trauma and extremities climbed by 9.1%. Spine was slower, growing only 1.9%. Sales were impacted negatively by 5.5% due to impact of foreign currency. Net sales included a […]
The FDA has announced a Class I Recall for the modular neck component of a hip joint replacement system made by Shanghai, China-based MicroPort Orthopedics. The recalled product is the PROFEMUR Long Cobalt Chrome 8 Degree Varus/Valgus Modular Neck, Part 1254. The affected lots of the modular neck were manufactured and distributed from mid-June 2015 […]
Orthopedic surgery is serious business for patients. But surgeons don’t have to take themselves too seriously. We’re proud to present periodic articles from GomerBlog.com, a satirical medical news website created by a bunch of wannabe stand-up comedians who ended up in healthcare. “Through humor and poking fun at ourselves, ” says the Gomerguy, “we hope […]
K2M Group Holdings is getting into the 3D printing business using titanium powder. The company introduced Lamellar Titanium Technology at the 2015 North American Spine Society (NASS) Annual Meeting in Chicago. Titanium Powder The technology, according to the company, starts with a titanium powder where the implants are grown through the selective application of a […]
DePuy Synthes’ third quarter revenue of $2.181 billion declined 0.7% from last year’s third quarter. If you include the negative 7% impact of a strong dollar, reported revenue declined by a whopping 7%. Knees did okay in the U.S., rising 2% due to strong sales of the Attune knee system. Worldwide, knee sales were flat. […]
Zyga Technology, Inc., has been issued two U.S. patents related to the design of the company’s proprietary SImmetry Decorticator and for a method for revision of a failed SI joint fusion surgery. On September 22, 2015, the company announced that U.S. patent number 9, 113, 919 for the design of the SImmetry surgical instrument “enables […]
The FDA has granted Pre-Market Approval (PMA) to OrthogenRx, Inc.’s GenVisc 850 hyaluronic acid (HA) as a knee replacement fluid to treat osteoarthritis. GenVisc had been approved in 60 countries outside the U.S. The product was developed in collaboration with Meiji Seika Pharma Co., Ltd. of Japan and subsidiary, Tedec-Meiji Farma S.A. in Spain. 18 […]
DePuy Synthes Trauma says it has launched Conform Flex, the only pre-hydrated demineralized cancellous bone tissue matrix for use in trauma-related extremity procedures for the foot and ankle, hand and wrists, including fusion, and for filling bone voids. The October 8, 2015 announcement was made at this year’s Orthopaedic Trauma Association Annual Meeting in San […]
Kevin Stone, M.D., believes the tendon of a healthy young pig can be used as a knee joint ligament replacement in humans. He founded Aperion Biologics, Inc. to develop and commercialize a product to treat patients and seek other alternatives to human-based sources of tissue used in surgical procedures. $20 Million Public Offering In late […]
The American Academy of Orthopaedic Surgeons (AAOS), the American Society for Metabolic and Bariatric Surgery (ASMBS) and 33 other medical societies, held the Second Annual Obesity Summit in Chicago in September. The group met to identify opportunities for collaboration in treating obesity. “We represent many different specialties, backgrounds and perspectives, but we’re all really treating […]
Stryker Navigation says it has the first patient tracker for minimally invasive spine surgery that doesn’t require an additional incision for navigation tracking. On September 28, 2015, the company announced the introduction of SpineMask Tracker, an adhesive surgical tracker which is placed on the patient’s back and enables automatic registration with a wide-variety of imaging […]
K2M Group Holdings, Inc. launched its Everest deformity spinal system at the Scoliosis Research Society’s (SRS) 50th Annual Meeting in Minneapolis the last week of September. It was the company’s fourth product introduction in its complex spine portfolio in the past year. According to the company, the system allows for faster insertion and increased pullout […]
It’s been four years since our friend Jeffrey Guyer passed away. His mother and father, Shelly and Rick Guyer, M.D., and their family have kept hope alive that a cure can be found for the cancer that took the young engineer’s life. We are honored to provide our readers with a chance to participate in […]
Chris Bono, M.D. says NASS went too far and walled off industry from its surgeon members. In a remarkable display of contrition in a SpineLine column, the incoming president of NASS acknowledged the damage caused by The Spine Journal’s attack on Infuse and swinging the pendulum too far in a leadership ethics purge.
Wright Medical Group, Inc. and Tornier NV’s $3.3 billion merger announced a year ago will cost them an ankle and toe. The companies announced on September 30, 2015 that the Federal Trade Commission (FTC) approved the deal on condition that Tornier’s U.S. right and assets related to total ankle replacements and total silastic toe joint […]
Ramesh Subrahmanian is leaving Stryker Corporation. Effective December 31, 2015, Subrahmanian will no longer serve as Group President, International, “as a consequence of a restructuring of the company’s international group, ” stated a company September 17, 2015 SEC regulatory filing. He’ll stay on in an advisory role for three months following his departure and continue […]
Bacterin International, Inc. has received notification that the U.S. Patent and Trademark Office has issued U.S. Patent No. 9, 114, 191 entitled “Process for Demineralization of Bone Matrix with Preservation of Natural Growth Factors.” According to a September 22, 2015 announcement by Xtant Medical Holdings, Inc., the patent covers demineralized bone matrices derived from cortical […]
When a hospital agrees to limit the number of orthopedic device vendors at their facility and standardize surgical procedures, some private practice surgeons fear that being required to use a new and unfamiliar implant system to save costs may jeopardize patient care. Ray Horwood, M.D. at the Cleveland Clinic’s Fairview Hospital is one such surgeon. […]
Robert Califf, M.D., a cardiologist, and the number two person at the FDA since March has been nominated by the White House to become the new head of the agency. His thoughts about the agency’s mission to “protect” and “promote” public health will be scrutinized by industry and consumer groups as Congress decides whether or […]
Rob Carson is Medtronic spine’s new head of strategy and marketing. Payment and healthcare systems have entered a new era where economics matter more than ever. Carson and his colleagues at the company have a plan to align economic and clinical outcomes to retake market share. Read what he told us.
Zimmer Biomet is commercializing subchondroplasty procedures from the knee to the foot and ankle. The company announced on September 15, 2015 that surgeons have performed more than 10, 000 such procedures since 2010, mostly in the knee. The subchondroplasty procedure, according to the company, is a fluoroscopic, minimally invasive outpatient intervention that addresses the defects […]
The legal Chinese water torture to the FDA’s dying off-label speech power continues. Soon the agency might be afraid to even issue a Warning Letter alleging misbranding. Sorrell, Caronia and Amerin First there was Sorrell v U.S. in 2011 where the Supreme Court said speech in the “aid of pharmaceutical marketing” is protected free speech […]
Blue Belt Technologies, Inc. announced on September 8, 2015, that its Navio robotics-assisted system is now providing commercial support for Smith & Nephew’s ZUK unicompartmental (uni) knee. The ZUK was introduced in 2004 and acquired by Smith & Nephew in June 2015 from Zimmer Holdings, Inc. Zimmer had to divest itself of the knee to […]
Minnesota-based Orthology has moved into New York City by acquiring NYSportsMed (NYSM). A September 10, 2015 press announcement said that NYSM currently operates three locations in the city at Columbus Circle, Union Square and Midtown. Orthology is also opening a location this month at 667 Madison Avenue. The companies hold themselves out as “an innovative, […]
If you are a physician who hired a vendor to submit data to the 2014 Physician Quality Reporting System (PQRS) via electronic health records and qualified clinical data registries (QCDR), your data is not going to be used for the 2016 value modifier. The Centers for Medicare and Medicaid Services (CMS) reported at the end […]
Xtant Medical Holdings, Inc., formerly known as Bacterin and X-Spine, announced on September 9, 2015 that the company’s Aranax Cervical Plate has been cleared for the market by the FDA. The company says the implant is the “latest generation of anterior cervical fixation with an enhanced locking mechanism, low profile features, increased screw angulation and […]
K2M, Inc.’s mono cervical plate system has scored a regulatory double with 510(k) clearance from the U.S. FDA and CE Mark in Europe. The regulatory victories for the company’s Pyrenees Mono Cervical Plate System, the company’s latest addition to its family of Pyrenees products, allows for the global availability and expansion of the product. The […]
Medtronic plc’s spine sales of $763 million for the quarter ending August 31, 2015, kept up with the general growth of global spine sales. But U.S. sales of $518 million lagged behind the market. With an extra selling week, spine sales grew a reported 7%. On a constant currency basis, sales rose 3%. Sequentially, those […]
Finally, Wright Medical Group, Inc. has achieved FDA Approval for its Augment Bone Graft. After paying $380 million to acquire BioMimetic and the product in 2013 and surviving one of the most dramatic FDA approval journeys in recent memory, the company is ready to jump into the ankle biologics market.
The FDA warned on August 28, 2015 that a class of diabetes drugs has been linked to severe joint pain. In a Drug Safety Communication, the agency said the type 2 diabetes medicines sitagliptin, saxagliptin, linagliptin, and alogliptin “may cause joint pain that can be severe and disabling.” In addition, a new Warning and Precaution […]
Stryker Howmedica Osteonics Corp. is voluntarily recalling 16, 992 elbow devices because of the potential of damage during shipping caused by a packaging problem. According to an August 20, 2015 Food and Drug Administration (FDA) notice, the recall includes five devices: the rHead lateral stem and Recon radial implant, both for replacement of the proximal […]
OsteoMed claims it is turning traditional lateral access to the spine inside out. Lateral spinal fusion can be daunting even by the most experienced surgeons. OsteoMed says it has made access to the lateral spine “simpler and more secure” with the full market launch of its PrimaLIF LLIF Lateral Interbody Fusion System. The system, according […]
Accountable Care Organizations (ACOs) in Medicare’s Shared Savings Program are supposed to make public not only how much money they saved, but also how they’ll spend the savings. According to a new report published in the American Journal of Managed Care (AJMC), just over half of the ACOs in the program shared what they would […]
Let’s say you are a device manufacturer that wants to conduct and pay for a prospective, randomized, double-blind, placebo-controlled trial that is also covered by CMS (Centers for Medicare and Medicaid Services) under its Coverage with Evidence Development (CED) program. The “Blinding Problem” But you have a “blinding” problem. One arm of the study of […]
Mark Barry, M.D. sued Medtronic plc in February 2014 alleging that the company infringed on his patents covering scoliosis treatments. The lawsuit offers some lessons for surgeons on the proper way to protect their inventions. Barry claimed that the company’s CD Horizon Legacy spinal system infringed on his patent entitled, “System and Method for Aligning […]
The FDA has extended the deadline for getting compliant with the new Unique Device Identification (UDI) system until October 24, 2015. According to an August 14, 2015 agency guidance, the deadline was moved back one month due to undisclosed “security vulnerabilities” when the agency’s Global Unique Device Identification Database (GUDID) was taken offline on August […]
The right to free speech means that the FDA cannot prohibit truthful off-label marketing claims. For the second time the federal courts have told the FDA to stop prosecuting and threatening device and drug makers with prosecution if they make truthful claims off-label. It’s another landmark. Read it here.
The U.S. relies on gathering clinical data to show a device is safe and effective before the FDA will grant approval. But that’s changing, according to a new study. Harlan Krumholz, M.D., the Yale University professor who was hired by Medtronic plc to review all the Infuse data, has just co-authored a study that found […]
They say you can hear the corn grow in Iowa in late summer. After the Republicans held their first presidential debate in early August, you could hear Dr. Ben Carson’s support grow as he moved into second place in the polls in Iowa. A new CNN/ORC poll out after the first Republican debate showed that […]
A whistleblower will receive $2.2 million of the $13.5 million dollar settlement announced in late July between NuVasive, Inc. and the U.S. Department of Justice. The company did not admit to any wrongdoing in the settlement, nor did the Justice Department require the usual Corporate Integrity Agreement (CIA) that allows the government to continue monitoring […]
A new report from EP Vantage says that in the first half of 2015, the FDA has already approved 26 devices with either premarket approval (PMA) or a humanitarian device exemption (HDE). That’s more PMAs and HDEs for new devices than for all of 2009, 2010 or 2013, said the report. At this rate, the […]
Starting October 1, 2015, your FDA user fees are going up by 4.2%. The FDA expects to collect a total of almost $130 million from industry over the course of fiscal 2016. A notice by the FDA in the Federal Register on August 3, 2015 announced the fee rates and payment procedures for medical device […]
The FDA has added total knee clearance to the previously cleared total hip application of Stryker Orthopaedics’ MAKO robotic system. An August 6, 2015 company announcement states that the clearance expands on current MAKO partial knee and total hip applications of the robotic reconstructive service line. In March, the FDA cleared the company’s use of […]
In 2003, Zimmer’s CEO, Ray Elliott put his corporate counsel, Dave Dvorak in charge of integrating Centerpulse into the company. Now CEO of Zimmer, Dvorak is pulling out the old Centerpulse playbook to restart momentum lost in a protracted regulatory process to acquire Biomet. Here’s his plan.
The Centers for Medicare and Medicaid Services’ (CMS) hip and knee bundling proposal (CCJR) will raise prices and limit choice, says Harold Miller the CEO of The Center for Healthcare Quality and Payment Reform. Bundling Badly In a policy brief, “Bundling Badly: Problems with Medicare’s Comprehensive Care for Joint Replacement Proposal, ” Miller says that […]
A Los Angeles jury has handed Zimmer Biomet Holdings, Inc. a $9.2 million loss over the company’s Durom Cup hip replacement system. It was the first trial loss for Zimmer over the system. According to published reports, Gary Kline filed suit against Zimmer after experiencing complications with the device and had to undergo two revision […]
The first two surgeries using Centinel Spine, Inc.’s Midline II-Ti fusion device have been performed in Texas and Florida. On July 28, 2015, the company announced that Jessica Shellock, M.D., Texas Back Institute, Plano. Texas, and James Billys, M.D., Florida Orthopaedic Institute, North Tampa, Florida, performed the surgeries. Shellock said she was impressed with the, […]
NuVasive, Inc. has escaped potential litigation and an intrusive Corporate Integrity Agreement (CIA) with the government for $13.5 million. On July 28, 2015, the company announced it had reached a tentative agreement with the U.S. Department of Justice (DOJ) stemming from the subpoena issued by the Office of Inspector General (OIG) of the Department of […]
Bacterin International Holdings, Inc. is combining its orthobiologics business with X-spine Systems, Inc.’s hardware products to form Xtant Medical Holdings, Inc. In a July 27, 2015 SEC filing, Bacterin said it intended to purchase the outstanding share of privately owned X-spine in exchange for approximately 4.24 million shares of Bacterin common stock and around $60 […]
After years of warning that bundled payments were coming, CMS proposed a mandatory bundled payment program for 750 hospitals performing hip and knee replacements. This is what Pay-for-Performance looks like. What does it mean for providers and device makers? We found out.
Stryker Corporation’s 2015 second quarter orthopedic sales rose 6.2% organically, (excluding currency swings) to $1.035 billion. Sales in the U.S. grew 8.3% during the quarter. U.S. spine sales growth of 9% was a noted “bright spot” by company CEO Kevin Lobo. Overall organic spine sales climbed 4.1%. Trauma and extremities rose 10.8%, while knee and […]
“The Donald” Trump is sucking the air out of our neurosurgeon, Ben Carson, M.D.’s, presidential balloon. Dr. Carson was seriously challenging top Republicans for the GOP nomination for the White House before Donald Trump began his bomb throwing march to Iowa at the beginning of July. On July 1, 2015, according to RealClearPolitics Average (RCP) […]
The FDA has just granted Centinel Spine, Inc., the first cervical multilevel indication for a stand-alone interbody device. The company, the first to gain such clearance, announced in late June that its STALIF C and STALIF C-TITM now can be used on-label in multilevel, cervical spine fusion procedures. Company Chairman and CEO John Viscogliosi said […]
Mindray Medical International Limited, based in Shenzhen, China, has swallowed up the remaining stake in Wuhan Dragonbio for $70.2 million. Mindray, China’s largest medical equipment manufacturer acquired a majority stake in Dragonbio, a manufacturer of orthopedic products for trauma, spine and joints procedures, in 2012 for $35.5 million. Since acquiring its majority stake, Mindray co-CEO […]
Surprise government inspections are coming in China’s medical device sector. Beginning in September, inspectors from the China Food and Drug Administration (CFDA) are going to start making unannounced visits to medical device manufacturers with products registered to be sold in China. According to Stewart Eisenhart of the Emergo Group, the surprise inspections are authorized by […]
The echoes of the integration storm at DePuy Synthes were still evident in the mid-2015 sales and earnings report BUT it also clear that the company has begun to settle in and settle down into a period of routine business operations.
German-based minimally invasive endoscopic spine surgery technology developer joimax GmbH has been cleared by the FDA to market the company’s Endoscopic Lumbar Interbody Fusion, or EndoLIF On-Cage: 3D-printed implant. Enabling Fusion In a July 13, 2015 press release, the company stated the new implant allows surgeons to use an inter-muscular approach, “similar to a mini […]
Knoxville, Tennessee based, privately held, ChoiceSpine, LP launched its Blackbird Posterior Cervical System for commercial markets on July 13, 2015. The system was cleared by the FDA in June 2014. Company Vice President of Research and Development Steve Ainsworth, Ph.D., said the system has had over 150 successful surgeries. Director of Business Development Anderson Collins […]
Medtronic plc used the recent IMAST meeting (International Meeting on Advance Spine Techniques) in Kuala Lumpur, Malaysia, to launch its CD Horizon Solera Voyager Spinal System for Minimally Invasive Spine procedures. Multiple Rod Insertion Options According to a July 8, 2015 company announcement, the Solera Voyager “expands upon the transforaminal lumbar interbody fusion (TLIF) procedure […]
Apparently no healthcare crime is too small to pursue for U.S. Attorney Carmen Ortiz of Massachusetts. A recent guilty plea by a former bisphosphonate drug sales manager is exhibit one. In 2010, Jeffrey Podolsky of New York, a former Warner Chilcott Sales U.S., LLC district manager, hatched a scheme to defraud payers to pay for […]
The FDA just approved Aesculap’s artificial lumbar disc. The marketplace for lumbar discs has been brutal. Cervical has fared much better as LDR has shown. Can Aesculap breathe new life into lumbar artificial discs? A couple of top spine surgeons are hopeful, but the opinions are not exactly universally held. Are the payers ready for Act II of lumbar artificial discs?
For the first time, ever, CMS (Centers for Medicare and Medicaid Services) is going to let “innovators and entrepreneurs” access detailed CMS data for “commercial purposes” to develop new products. CMS Acting Administrator Andy Slavitt made the announcement at the recently completed Health Datapalooza meeting. New Tools to Improve Care “Data is the essential ingredient […]
After receiving FDA 510(k) clearance in January, K2M Group Holdings, Inc. has now launched its next generation pedicle screw system—the MESA 2 Deformity Spinal System. Cutting Surgical Steps in Half A July 2, 2015 announcement by company President and CEO Eric Major states the MESA 2 offers “new capabilities” to the underlying MESA technology and […]
The North American Spine Society (NASS) wants to know what you think about the diagnosis and treatment of low-back pain. The organization’s Low-Back Pain Guideline Work Group has drafted a list of clinical questions to be addressed in an evidence-based clinical practice guideline. The guideline addresses seven sections, including: Diagnosis Imaging Medical & Psychological Treatment […]
Jeff Binder has his new assignment from one of the private investment firms that brought him in 2007 to run Biomet, Inc. after the company went private.
On June 8, 2015, Zimmer Inc. initiated a Class I Recall of its M/L Taper with Kinectiv Technology Femoral Stems and Necks. Manufacturing Residue Due to a process monitoring failure, higher-than-expected amounts of manufacturing residues were left on the devices made fromMarch 31, 2015 through April 20, 2015. The residues can cause “serious adverse health […]
Charlie Chi, Ph.D., the former CEO of OtisMed Corporation has been sentenced by the U.S. District Court of the District of New Jersey to 24 months in prison, one year of supervised release and ordered to pay a $75, 000 fine. Selling Adulterated Devices Chi pleaded guilty last December to introducing adulterated medical devices into […]
Over the last 30 days neurosurgeon and AAOS keynote speaker Ben Carson, M.D. has emerged as an early leader in the GOP Presidential Primary. Dr. Carson’s campaign for the White House has been gaining steam with likely Republican voters, while front-runners Jeb Bush and Scott Walker have slipped. Florida Senator Marco Rubio has also gained […]
In 2009 we wrote about Afghan orthopedic surgeon Lt. Colonel Mohammad Wardak, M.D.’s invention of the Afghan external fixation device for the knee. Dr. Wardak had to develop the device surreptitiously while the Taliban was in power. His bravery in pursuing innovation under dangerous cultural conditions was inspiring. Published Results Results of the effectiveness of […]
For the second time in three years, U.S. Supreme Court Chief Justice John Roberts has saved the Affordable Care Act (ACA–Obamacare) from a constitutional challenge. This time, in King v Burwell, he was joined by Justice Anthony Kennedy. The challengers said the law only allowed insurance subsidies to people enrolled in a healthcare exchange established […]
Atiq Durrani, M.D. jumped bail and hightailed it on the eve of his federal corruption trial at the end of 2013. Everybody asked, “Where’s Durrani?” We found him in Pakistan performing spine surgeries. Here’s what he left behind.
Zimmer Biomet has finally been born. Zimmer Holdings, Inc. said on June 24, 2015 that is has received U.S. Federal Trade Commission (FTC) clearance for the merger with Biomet Inc. after agreeing to sell its Unicompartmental High Flex Knee (ZUK) system in the U.S. market to Smith & Nephew. The ZUK deal will close within […]
SpineGuard, S.A. has finished raising the rest of a $3.1 million equity round of financing to accelerate the market launch of its “smart screw” for spine surgery. Claiming to have the world’s first “smart screw” to make surgery “safer, ” the company said on June 15, 2015 the equity came from two Paceo equity line […]
DePuy Synthes and the AO Foundation (Arbeitsgemeinschaft für Osteosynthesefragen) are going to continue Synthes’ 55-year history of professional education and new product development cooperation for at least five more years. On June 18, 2015, the two organizations announced the signing of a five-year cooperation agreement. Through the agreement, DePuy Synthes will be the “industry partner […]
The leaders of Cerapedics, Inc. think the FDA is on the verge of approving a Premarket Approval (PMA) application for the company’s i-Factor peptide enhanced bone graft. The company announced on June 16, 2015 that it has been informed that the agency will not need to convene an advisory panel to review the company’s application […]
The first bellwether trial over Zimmer Holdings Inc.’s NexGen knee implant will start on October 13, 2015. Over 1, 300 lawsuits have been filed by patients implanted with knee. The device received FDA clearance in 1995 and more than 5 million implant procedures have been performed since then. Lawsuit Consolidation In 2011, the U.S. District […]
The federal government continues to warn physicians about getting involved in the business of medicine. On June 9, the Office of Inspector General (OIG) of the Department of Health and Human Services (HSS) issued a fraud alert warning physicians about medical directorship arrangements with healthcare companies. This warning follows the OIG’s special fraud alert in […]
There’s not much good that can be said about foot drop. It keeps people from staying in motion and can aggravate co-morbidities like diabetes and high blood pressure. But the Kinetic Kids program in San Antonio, Texas, benefits whenever a ToeOFF ankle foot orthosis made by Allard USA is sold. Through a grant from the […]
Dom Coric, M.D. of Carolina Neurosurgery and Spine Associates, has successfully implanted the 100th FLXfit 3D expandable cage. Expanding Orthopedics Inc., the Akiva, Israel-based company that manufactures the device announced FDA clearance of the device last summer. The first surgery using the FLXfit was performed last December by John Peloza, M.D. at the Texas Back […]
Medtronic plc has rid itself of another Infuse lawsuit. Three shareholder lawsuits filed against former and current directors and officers of Medtronic, Inc. (now Medtronic plc) in Minnesota state court over alleged off-label Infuse promotion, have been dropped by the plaintiffs, with prejudice. A case dismissed with prejudice is over and done with, once and […]
When is it time to step away from the operating table and lay down that scalpel? And who should decide? The American Medical Association (AMA) adopted a plan on June 8, 2015 to create competency guidelines to help decide when it’s time for an aging physician to retire. This is new territory for any medical […]
Ted Bird has been elected chairman of the board of Israeli-based ApiFix, Ltd.
CMS (Centers for Medicare & Medicaid Services) just updated rules governing how providers, such as ACOs, (Accountable Care Organizations) can get their share of the Medicare Shared Savings Program. The new rule creates a new Track 3, which includes, according to the agency, higher rates of shared savings, the prospective assignment of beneficiaries, and the […]
SpineCraft, LLC’s Astra Spine System has been cleared by the FDA for sale in the U.S. According to a recent announcement by the company, the posterior spinal fixation system is intended to “provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute […]
Senator Charles Grassley is turning his investigative attention to alleged fraud in the Medicare Advantage (MA) program. The program is a kind of private Medicare for about 16 million elderly beneficiaries paid for by Medicare and run by private insurers. Grassley, a co-father of the Sunshine Act, recently sent letters to CMS (Centers for Medicare […]
On June 1, 2015, the government released the second year of Medicare payments to physicians, hospitals and suppliers. The highest-paid specialists were radiation oncologists, who received an average of $403, 512 from Medicare for their services. That was closely followed by dermatologists ($331, 108), vascular surgeons ($329, 874), and ophthalmologists ($326, 621). Medicare paid all […]
Richard Deyo, M.D., MPH, is the 2015 ISSLS Wiltse Lifetime Achievement Award winner.
The government finally nailed a POD surgeon. Aria Sabit, M.D. has pled guilty to billing insurers and government payers for unnecessary and, on occasion, fake surgeries to make more money for himself and his POD. There’s a sentencing hearing in September. His injured patients would probably like to send him back to his native Afghanistan for Taliban justice.
The end is in sight. Zimmer Holdings, Inc. has found buyers for products the Federal Trade Commission (FTC) says the company has to divest in the U.S. in order to get approval for the acquisition of Biomet, Inc. Diversifying Knee, Elbow and Cement Assets On May 28, 2015, Zimmer announced finalized agreements with unnamed buyers […]
The FDA issued a rare PMA Approval Order (pre-market approval) on May 26, 2015 as the agency approved VertiFlex, Inc.’s Superion Interspinous Spacer System. The FDA’s expert orthopedic panel recommended approval of the device back in February. Least Invasive Spinal Stenosis Treatment A statement from the company said the Superion has proven to be a […]
Employees with health insurance as part of their compensation package are paying more in total healthcare costs as well as paying a higher percentage of their costs in 2015. A Milliman Medical Index (MMI) study says the total bill for healthcare for a typical American family of four with employer-based insurance will rise 6.3% to […]
After a couple of quarters of spine revenue growth, Medtronic plc’s most recent quarter saw sales decline by 2% on a constant currency basis. Revenue of $743 million, means Medtronic lost 1.6% of overall spine share during the quarter, said Needham & Company analyst, Mike Matson. U.S. sales of $516 million declined by 4%. Releasing […]
Orthofix International N.V. is once again up-to-date with its financial reporting. On May 18, 2015, the company reported sales for the first quarter of the year. The report comes after a year’s worth of radio silence while the company was restating previous quarterly reports. First Quarter 2015 Total net sales in the quarter were $89.8 […]
A patient in Germany with a degenerative cervical spine has received the world’s first 3D printed titanium fusion implant. EIT Emerging Implant Technologies GmbH (EIT), made that claim in May 19, 2015. Uwe Spetzger, M.D., professor and chairman of the Department of Neurosurgery of the Klinikum Karlsruhe in Germany planned and performed the operation. Spetzger […]
SpineFrontier, Inc. sent Patricia Katz, a company accountant, for compliance training. After checking with the FDA, Katz told company officials they were out of compliance with FDA regulations. The company disagreed and fired Katz for unrelated reasons. Now she’s suing and claiming retaliation as a whistleblower. Read the lessons here.
Medical device companies are increasingly conducting clinical studies outside the U.S. and then using the data in regulatory submissions to the FDA. On April 22, 2015, the FDA issued a draft guidance that lays out the factors the agency will consider when device makers submit the data from those foreign studies. The draft guidance does […]
Amarin Pharma, Inc. has filed a proactive First Amendment suit against the FDA regarding the enforcement of the prohibition of off-label promotion that may end up with huge implications for medical device makers. “Truthful and Factual” Information On May 7, 2015, Amarin and four physicians, Drs. Jonathan Herbst, Eric Rishe, Peter Gottesfeld and Ralph Yung, […]
Moximed, Inc. has just raised an additional $33 million to try and gain FDA approval for its KineSpring System, a joint unloading knee implant for pre-arthroplasty patients. Think shock-absorber to put a spring in your step. According to the company, it is designed to be a first surgical option for patients with knee osteoarthritis (OA). […]
Stryker Corporation and its subsidiary Howmedica Osteonics Corp. of New Jersey have reached a $3 million settlement in a class action lawsuit that accused the company of violating California labor law by failing to reimburse sales associates for expenses such as mileage, telephone costs and other business expenses. Tanner Trosper started the class action lawsuit […]
Michel Orsinger, the soon-to-be departed head of DePuy Synthes, was arrested for allegedly assaulting a female family member outside a Sunday morning church service.
Michel Orsinger is out as head of Johnson & Johnson’s (J&J) DePuy Synthes orthopedics business following a reorganization of J&J’s medical device businesses. Single Medical Devices Group The company is creating a single Medical Devices Group by integrating its surgery and orthopedics business under the leadership of Gary Pruden, head of the surgery business. Pruden […]
Zimmer Holdings, Inc.’s first quarter revenue was slightly below Wall Street expectations with hip sales dragging down good knee, extremity and spine sales. Revenue during the quarter of $1.13 billion was up 2% on a constant currency basis and adjusting for extra selling days (adjusted). Revenue Results Adjusted reconstructive revenue was up 5% to $852 […]
The FDA has cleared Medtronic plc’s latest anterior cervical plate system for anterior cervical discectomy with fusion (ACDF) procedures. The ZEVO system is now commercially available for the treatment of “cervical disc disease, trauma, tumors, deformity, pseudoarthrosis, and/or failed previous fusions, ” according to a company announcement. The system features lower-profile plates with minimal thickness […]
Where the Pacific meets the Sea of Cortez at the tip of the Baja Peninsula, spine surgeons can find the latest spine technology. On June 18, 2015, the famous “Cabo Spine Meeting” will hold its 12th Annual Meeting. In such splendid isolation, industry and surgeons are free to exchange ideas. The debates are fun, the sessions are informative and the setting is sublime.
Medtronic plc is pushing hard at this year’s 83rd annual meeting of the American Association of Neurological Surgeons (AANS) in Washington, D.C. to announce the launch of new spine products. The latest announcement is the launch of the company’s stand-alone interbody cage, the Divergence. Perhaps the company is choosing to highlight technology at AANS instead […]
Bacterin International Holdings, Inc.’s Acellular Dermal Matrix allograft (ADM), hMatrix, has received coverage from Novitas Solutions, Inc. (Novitas). Novitas is one of eight Medicare Administrative Contractors (MACs) “that are responsible for processing Medicare claims in one or more of 12 geographic areas or “jurisdictions” in the U.S. In addition to processing claims, each MAC is […]
The second round of the Sunshine Act industry reports of physician payments just finished. Physicians have until May 21, 2015 to double check what industry is telling CMS. The process isn’t easy, but there’s help. Read how you can successfully check, verify and if necessary, dispute what industry reported.
The FDA has stopped fooling around and on April 27, 2015 asked the U.S. Justice Department to file a complaint and proposed consent decree with a federal judge regarding Medtronic plc’s SynchroMed drug infusion system and the Neuromodulation quality system. “Adulterated” Devices The complaint alleges that Medtronic, its Chief Executive Officer Omar Ishrak and Senior […]
NuVasive, Inc. announced on April 29, 2015 that it has agreed “in principle” to pay the government $13.8 million to “resolve” an ongoing investigation by the Office of Inspector General (OIG) of the Department of Health and Human Services. The OIG issued a federal administrative subpoena to the company in the second quarter of 2013 […]
Truven Health Analytics issued its annual list of the 15 Top Health Systems in the U.S. on April 20, 2015. Systems in Minnesota, Ohio and Indiana led the way. Truven Health aggregates “rigorous analysis of individual hospital performance metrics into system-level data” to identify the 15 best health systems in the nation. The “quantitative study […]
According to a study published on April 27, 2015 in JAMA Internal Medicine, docs are turning blue and are now giving more campaign contributions to Democrats than Republicans. Democrats 55% – Republicans 45% The proportion of all physician donors contributing to Republicans fell from 69% in the 1993 to 1994 cycle to 44% in the […]
Privately owned, Ortho Kinematics, Inc. (OKI), has raised another $9.6 million in Series C equity financing to fund expanded commercialization for its VMA (Vertebral Motion Analysis) diagnostic tool. An April 14, 2015 company announcement said the tool focuses on spine imaging informatics, “for the radiographic assessment of spinal motion and instability.” “Gentle” Spine Bend The […]
Lima Corporate introduced a new total knee in April and agreed to buy the knee and elbow systems from Zimmer Holdings Inc. and Biomet, Inc. that European regulators said needed to be divested in order to approve the Zimmer Biomet merger. On April 14, 2015, the Udine, Italy-based company announced that it has reached an […]
Stryker Orthopaedics just reported its fourth $1 billion quarter in a row. For the first quarter of 2015 sales reached $1.023 billion, up 2.4% on a reported basis and up a whoppin’ 6.5% if you consider the 5.1% unfavorable impact of the strong U.S. dollar and exclude the impact of acquisitions. On a constant currency […]
In September 2013, ConforMIS, Inc. filed a patent infringement suit against Wright Medical Group, Inc. In January 2014, Wright Medical sold the patents at issue to MicroPort Orthopedics. ConforMIS alleged that Wright Medical’s Prophecy knee and ankle system infringed on four ConforMIS patents. On April 13, 2015, the companies announced a definitive agreement to settle […]
Extendable femoral and total knee replacement devices made by UK’s Stanmore Implants Worldwide Ltd have been refused entry into the U.S. by the FDA. “Entry Refused” The FDA is throwing the quality system rulebook at Stanmore and notified the company back in November 2014 in a Warning Letter that entry into the U.S. of their […]
Congress finally dumped the hated sustainable growth rate formula that constantly threatened draconian cuts to physician payments from Medicare. The replacement offers physicians new rewards and risks and introduces MIPS and APS. Now the fight over defining “quality” starts. Read what the new law brings.
DePuy Orthopaedics, Inc. issued a voluntary Field Safety Notice (FSN) for all lots of its LCS Complete RPS Knee System (LCS) this past March. Higher Revision Rates Australia’s regulatory body, the Therapeutic Goods Administration (TGA), had recently notified the company that based on information from the Australian Orthopaedic Association National Joint Replacement Registry; the system […]
Johnson & Johnson’s (J&J) DePuy Synthes’ reported revenue of $2.33 billion was down 3.8% in the first quarter of 2015. Excluding the 5.9% negative currency impact of a strong dollar, sales were up 2.1%. Utilization Rates, Insured, Up Company executives told analysts on April 14, 2015, that they saw a third consecutive quarter of sequential […]
The Zimmer Biomet deal may be delayed. Zimmer Holdings, Inc. announced on April 13, 2015 that the “outside date” for completing the proposed merger with Biomet, Inc. has been extended to July 23, 2014. The company still expects the deal to close by the end of April or shortly thereafter. The original agreement between the […]
By launching the STAPix Superelastic Nitinol Staple Fixation System, Houston-based Instratek claims to be the first company to offer a “fully functional” sterile staple inserter. In an April 9, 2015 press release, the company says the system is the “most advanced” device of its kind and enables extremity surgeons to “confidently control” staple arm width […]
After years of pirates, rogue employees, federal investigations, unreliable financial reports and delayed SEC filings, Orthofix has finally lifted the veil and revealed its financial condition. What did we learn? Company CEO Brad Mason tells OTW it’s a new and transformed company.
Biomet, Inc. likely reported its last quarterly financials to investors as a stand-alone company on April 9, 2015. Reported revenue was down 2.6% to $809 million for the quarter that ended on February 28, 2015. But that wasn’t the important part of the story, says Wells Fargo analyst Larry Biegelsen. Revenue Down – Margins and […]
Bonnie Simpson Mason, M.D., has probably directly helped more than 1, 000 female and minority medical students, residents and orthopedic surgeons over the past ten years through her nonprofit organization.
Zimmer Holdings Inc. has recalled 11, 658 parts used in its Persona Trabecular Metal Tibial Plate/Persona TM Tibia knee implant systems. According to the Food and Drug Administration (FDA), Zimmer is initiating the voluntary global recall following an increase in complaints of “radiolucent lines and loosening.” All sizes and lots of the affected devices are […]
Bacterin International Holdings, Inc. has been issued U.S. Patent No. 8, 992, 964 by the U.S. Patent and Trademark Office for its OsteoSponge human demineralized cancellous bone product. According to an April 6, 2015 company announcement, the patent entitled, “Process for Demineralization of Bone Matrix with Preservation of Natural Growth Factors, ” includes claims that […]
John Lovejoy Jr., M.D., is a retired orthopedic surgeon. But he’s not done being a physician.
Three U.S. Attorneys recently told a group of compliance officers that they are placing an increased emphasis on medical device manufacturer misconduct. Increased Emphasis and Coordination The prosecutors from California, New Jersey and Tennessee, according to Tom Sullivan of Policy and Medicine, said the reasons for the uptick are that there are a number of […]
Dublin-based Medtronic plc has agreed to pay the U.S. government $4.4 million to settle charges that the company deliberately brought spinal surgery devices in from China, relabeled them “Manufactured in Memphis, Tennessee, ” and then sold them to the government for use in U.S. soldiers and veterans. In an April 2, 2015 Department of Justice […]
For 40 years, ambulatory surgical centers (ASC) have been an oasis for surgeons who want to own their own means of production, control their practices and realize the financial benefits of owning facilities. But on March 23, 2015, Tenet Healthcare became the King of a fragmented ASC jungle as “Big Health” begins the march towards consolidation.
Ben Carson, M.D., the famous Johns Hopkins neurosurgeon is expected to announce soon that he will seek the Republican endorsement for the White House. He’s famous, articulate, well-financed, but a little gaffe-prone. He’s also leading Republican bluebloods in some polls. Does he have a prayer? We took a look.
Ben Carson, M.D., the famous Johns Hopkins neurosurgeon is expected to announce soon that he will seek the Republican endorsement for the White House. He’s famous, articulate, well-financed, but a little gaffe-prone. He’s also leading Republican bluebloods in some polls. Does he have a prayer? We took a look.
The specter of PODs (Physician-Owned Distributors) was back in court recently as a federal district judge denied a motion to dismiss a False Claims Act case against a physician and his fiancée who owned a spinal implant distributorship. In U.S. ex rel. Cairns v D.S. Med, LLC, (DS Medical), the government alleges that the joint […]
The rumors of impending European approval of Zimmer Holdings Inc.’s $13.3 billion takeover of Biomet, Inc. were true. On March 30, 2015, the company announced that the European Union Commission cleared the deal conditional on the execution of divestiture of Zimmer’s uni knee, ZUK and Biomet’s Discovery Elbow throughout Europe. Zimmer must also divest Biomet’s […]
Stryker Corporation’s Mako robotic system has a new clearance from the FDA for a total hip replacement application. The company announced the clearance and launched the hip application on March 25, 2015 at the 2015 American Academy of Orthopaedic Surgeons (AAOS) Annual Meeting in Las Vegas. The Mako system, according to the company, will be […]
The government says more than 16.4 million people have signed up for health coverage since the inception of the Affordable Care Act (Obamacare) five years ago. That has turned into a multi-billion windfall for hospitals and state governments. It’s an even bigger windfall for states that voluntary expanded Medicaid coverage in their states. In 2014, […]
Harry Paul of Port Washington, Long Island, New York, got to speak to the President about his new type of spinal implant that expands over time.
Endoscopic procedures can raise serious patient safety issues, as demonstrated by the recent “superbug” outbreak linked to reusable medical scopes at Cedars-Sinai Medical Center. Reusable arthroscopes also get damaged, worn out and cost money to clean up. Integrated Endoscopy, Inc. says it has the solution with its single-use nuvis Arthroscope. The company is launching the […]
April Fools Day is almost here. That’s the day a mandated 21% cut to fees paid to physicians by Medicare is mandated by the sustainable growth rate (SGR). Congress has not acted. While commonly called the “doc-fix, ” it’s really a Medicare “beneficiary-fix.” Cutting money to pay for senior health services will hurt seniors, not […]
Tornier N.V., says its newly FDA cleared Simpliciti Shoulder system is a “first to market” system for an earlier intervention option for younger and active patients. In a March 10, 2015 announcement, the company said the shoulder system provides surgeons with an “efficient, repeatable surgical technique that is intended to preserve both the patient’s native […]
Ranfac Corp. recently launched a proprietary Marrow Cellution Bone Marrow Aspiration system, which the company claims allows a clinician to precisely reposition the aspiration system to a new location in the marrow after each 1mL, with a single entry point. The company says the device has, “shown an ability to increase concentrations of stem cell […]
Unnamed sources say European antitrust regulators have decided to give conditional approval to Zimmer Holdings, Inc.’s proposed $13.4 billion takeover of Biomet, Inc. Reuters reported on March 18, 2015 that two people, “with knowledge of the matter, ” informed the news organization of the pending approval. Zimmer sweetened its concessions to the Europeans in December […]
Zimmer Holdings, Inc.’s Vivacit-E Line for the Trabecular Metal Reverse Shoulder System has been used for the first time in the U.S. for a reverse should replacement. A company announcement on March 16, 2015, states the Vivacit-E HXPE is a highly crosslinked polyethylene (HXPE) and is a “high-tech bearing surface offering oxidative stability and low […]
The Glyder Facet Restoration device, made by Zyga Technology, Inc., has been implanted in the first patient. The surgery took place on the island of Cyprus at the American Institute of Minimally Invasive Spine Surgery. The surgery, according to a March 4, 2015 company press release, was performed on a patient with a previous total […]
The disruption of old healthcare models ushered in by the Affordable Care Act has thrown patients, physicians and healthcare providers into a brave new world. How are those actors feeling about their place in this new world? Three recent polls produced some surprising findings. See them here.
Bacterin International Holdings, Inc. has signed a national distribution agreement with Spartan Medical, Inc. A March 10, 2015 announcement from Bacterin says Spartan Medical will distribute Bacterin’s proprietary product portfolio of bone graft materials to medical centers affiliated with the U.S. Department of Defense (DoD) and the U.S. Department of Veteran’s Affairs (VA). Spartan Medical […]
Zimmer Holdings, Inc. just lowered the cost of the acquisition of Biomet, Inc. and fortified its pocketbook to complete the deal. The company announced on March 11, 2015 that it has agreed to sell $7.65 billion of senior notes through a consortium of Wall Street banks. The “price” of seven tranches of the notes averages […]
The Affordable Care Act (aka Obamacare) just got 29% more affordable. According to the nonpartisan Congressional Budget Office (CBO), slowing healthcare costs due to slower rising insurance premiums and fewer people than were previously thought to be without insurance, are driving down the price of the law. Estimates by the CBO released on March 9, […]
Florida-based OrthoNOW has opened its first orthopedic urgent care center franchise in Ft. Lauderdale, Florida. OrthoNOW Weston celebrated its grand opening on March 3, 2015. The center has a team of orthopedic specialists to treat broken bones, sprains, torn ligaments and muscles, cuts, sports medicine and workers compensation injuries. The facility is equipped with full […]
Johnson & Johnson’s DePuy Synthes Companies and the Human Performance Institute have developed the Patient Athlete program. The program, according to the company, is part of a J&J wellness platform that focuses on prevention, behavioral health and chronic disease support. Alex Gorsky, J&J’s chairman and CEO, announced the initiative on February 26, 2015 in Orlando […]
They were not overwhelmed with the evidence and underwhelmed with the claim that the Superion Interspinous Spacer is not inferior to the X-STOP. But in the end, members of the FDA’s Orthopaedic device panel voted to recommend approval of VertiFlex’s device by the FDA. Read what panel members said.
On March 2, 2015 a U.S. appeals court ruled that a $101.2 million patent infringement award against NuVasive, Inc. in favor of Medtronic Plc was excessive and ordered a new trial to determine new damages. “We look forward to the upcoming retrial, ” said Alex Lukianov, NuVasive’s chairman and CEO. “Erroneous Damages” The nation’s top […]
If you were a minority owner with no management responsibilities in a Medicare enrolled clinic that has any unpaid “Medicare Debt, ” you can now be prevented from re-enrolling in the Medicare program. A little noticed announcement of a new final rule issued by the Centers for Medicare and Medicaid Services (CMS) in December2015 titled: […]
Kevin Lobo and Stryker Corporation’s Board of Directors promised its shareholders $2 billion in the form of a share repurchase program on March 3, 2015. That’s $2 billion not available to make an offer for Smith & Nephew (S&N). This buyback is in addition to the $538 million already authorized to buy back shares. Altogether, […]
Aetna, Assurant Health, Humana and UnitedHealthcare released state and local cost information for about 70 common health conditions and services at the end of February. Health Care Cost Institute and Guroo.com The information was released by the Health Care Cost Institute (HCCI), a non-profit organization through their consumer website called, Guroo. The data is based […]
Is there going to be a spike of requests for knee replacement procedures in the U.S. this spring? A top Wall Street orthopedic industry analyst asked recently if orthopedic device makers will benefit from the uncertainty of the Supreme Court’s upcoming King vs. Burwell arguments and decision about whether or not patients enrolled in the […]
Aria Sabit, M.D., a spine surgeon, comes from a blue blood Afghan political family. He went to California, joined a POD, got sued by the government and headed for Michigan. Where, the government is alleging, he billed Medicare for scam surgeries. Then things got really weird in an international, hidden gemstones, “Topkapi” kind of way.
Minnesota’s Spineology, Inc. claims Tennessee-based Wright Medical Technology, Inc., “willfully” infringed on one of its patents. In a lawsuit filed on January 27, 2015 in a Minnesota federal court, Spineology says that in October 2006 it sold Wright Medical 50 of its expandable reamers, “solely for Defendant’s use in procedures for core decompression of the […]
ChoiceSpine, LP acquired Steve Ainsworth, Ph.D. as vice president of Research and Development and Tom McLeer as senior executive vice-president.
There are 1, 400 new DePuy ASR metal-on-metal hip patients who are now eligible to participate in the U.S. Settlement Program. DePuy Orthopaedics, Inc. has agreed to extend the existing U.S. Settlement Program to include eligible ASR hip implant patients in the U.S. who had surgery to replace their ASR hip after August 31, 2013, […]
AdvaMed, the medical device industry’s largest trade group, has unveiled an “Innovation Agenda” which it says will not cost a lot of tax dollars because the recommendations are mostly process reforms. The set of policy proposals were released on February 10, 2015 and outline a series of regulatory, reimbursement, tax, international trade and R&D reforms […]
The American Academy of Orthopaedic Surgeons (AAOS) officially opened its new 180, 000-square foot, five-story building on February 21, 2014 in Rosemont, Illinois. The building will house the Academy’s headquarters and more than 25 orthopedic organizations and a state-of-the art Orthopaedic Learning Center (OLC). Along with AAOS, the equity partners for the headquarters are: the […]
Orthopedics is going to the dogs in Valencia, Spain. Scientists at CEU-UCH Cardenal Herrera University in that city have patented a cutting device they believe can be applied to surgeries to correct deviations in long bones of humans. So far they’ve only tried it on the long bones of dogs. Orthopedics and Veterinary Medicine History […]
The orthopedic community’s memorial service for Dane Miller is being streamed live online from the Manahan Orthopaedic Capital Center on the campus of Grace College & Theological Seminary in Winona Lake, Indiana on Friday, February 20 at 1:00 p.m (eastern time zone). To view the service, please click here.
Privately held Precision Spine, Inc. of Parsippany, New Jersey, is refinancing its debt and building a war chest to make acquisitions. Jim Pastena, the company’s chairman and CEO announced on February 16, 2015 that the company has finalized “a major financial agreement” to give the company the financial tools to “grow aggressively” by “pursuing targeted […]
Ahhh, the luck of the Irish. Dublin-based Medtronic plc reported on February 17, 2105 that sales of Infuse BMP (bone morphogenetic proteins) have climbed almost double-digits in each of the last two quarters. Luck and the pluck of Omar Ishrak, the company’s CEO and chairman. The company continues to believe that the BMP business has […]
Dane Miller’s passing feels like a family member has died. On a personal level, he impressed, influenced and was beloved by thousands of physicians and industry executives all over the world. On a professional level, he improved the lives of literally millions of patients worldwide. How do we explain the importance and love of Dane Miller? We begin with a dream.
Dublin-based Medtronic plc announced FDA 510(k) clearance for expanded indications of its Vertex spinal reconstruction system. The clearance, according to a February 16, 2015 company statement, allows for “lateral mass and pedicle screws to be used as a form of fixation to treat various pathologies occurring in the posterior cervical spine.” The clearance makes the […]
Olive Medical Corporation, a Utah-based privately held manufacturer of high definition (HD) visualization systems for minimally invasive surgery (MIS), has been acquired by DePuy Synthes. The 20 person company was founded in 2009 and provides the HD equipment to the operating room and physician offices. Its equipment has been sold in 20 countries and all […]
It is with a heavy heart that we announce the passing of Dane A. Miller, Ph.D., founder and CEO of Biomet, Inc.
The FDA has cleared Paris and San Francisco-based SpineGuard S.A.’s PediGuard technology for use by surgeons in the U.S. On February 3, 2015, the company announced that its technology, which it claims allows surgeons to do a better job of placing pedicle screws into patients during a minimally invasive procedure and reduces the amount of […]
The auction ended on January 22, 2015 and Baxano Surgical, Inc. successfully completed the sale of its minimally invasive spine products. Ken Reali, Baxano’s president and CEO, told OTW on February 6, 2015 that the acquisition of the products is a “testament to the opportunity these technologies have to continue to help patients and drive […]
Zimmer Holdings, Inc. has made a second proposal to the European Commission (EC) to get the regulators to approve their planned acquisition of Biomet, Inc. The company announced on February 10, 2015, that the latest “revised remedy package” is generally consistent with the first divestiture proposal submitted to the EC in December. The original proposal […]
It was one of the most enduring relationships in healthcare. Uncle Sam and FeeFee (“fee-for-service.”) But the couple grew apart and a new flame, PayFee (“pay-for-performance, ”) with her siren song of “quality over quantity” stole Uncle Sam’s heart. What’s it mean for the $2.9 trillion U.S. health system and specialty docs? We found out.
Hospitals have been hit with Medicare payment penalties ranging from 1% to 2% of all Medicare payments for readmissions following surgery associated with the management of myocardial infarction, heart failure, and pneumonia. Hip and knee surgeries are expected to be added to the list in the coming year. Fred Pollock, M.D. and colleagues studied causes […]
Margaret Hamburg, M.D., who became the 21st commissioner of the FDA almost six years ago, is reportedly leaving the agency.
Wright Medical Group, Inc. has received a “Second Request” from the Federal Trade Commission (FTC) regarding its proposed merger with Tornier N.V. Second requests are typically made when the FTC staff has heard from potential customers that there may be some difficulties in replacing products sold by the merged entity. Zimmer Holdings Inc. received such […]
Zimmer Holdings, Inc. “held reconstructive share in the fourth quarter of 2014 with a slight share gain in knees offsetting a slight share loss in hips, ” according to Needham & Co. analyst, Mike Matson. Joanne Wuensch of BMO Capital Markets called it a “solid quarter” as Zimmer prepares for Biomet, Inc. That’s how the […]
Three experts on FDA data inspired by Moneyball-type statistical analysis look at the figures the agency has been touting about an improved 510(k) clearance program. The FDA averages look good. But averages can mask patterns. See what they found.
Knoxville, Tennessee-based, ChoiceSpine, LP has acquired Baxano Surgical Inc.’s VEO Lateral Access & Interbody Fusion System. The principals of ChoiceSpine, Marty Altshuler and Rick Henson, said they look forward to building relationships with previous VEO users and this provides a great opportunity to grow their Western footprint. “By adding a lateral system to our product […]
Stryker Corporation’s 2014 fourth quarter orthopedic sales of $1.11 billion were roughly in line with Wall Street expectation and rose 4.5% on a constant currency basis from the previous year’s quarter. On a reported basis, hips, knees and spine dropped 3%, 2.2% and 2.5%, respectively. Trauma saved overall sales by climbing 9.2%. There was some […]
Aesculap Implant Systems, LLC has introduced a new interbody system for PLIF (posterior lumbar interbody fusion) procedures which combines an osteoconductive porous titanium coating with a PEEK radiolucent core. ProSpaceXP System According to a January 21, 2015 company statement, the ProSpaceXP Interbody System features the company’s “innovative” PlasmaporeXP osteoconductive porous titanium coating with the PEEK […]
Toronto-based SDRI, Inc. says it has a new cervical disc with “revolutionary” geometry which will be distributed in Germany, Austria and Switzerland by Joimax GmbH. The five-year exclusive distribution deal for SDRI’s Synergy disc was announced by SDRI on December 12, 2014. Uniqueness Claim The company claims its disc is the first and only artificial […]
Alex Gorsky, the chairman of Johnson & Johnson sounded like a happy man when he reported fourth quarter results on January 20, 2015. His subsidiary, DePuy Synthes, showed 3% operational growth over the prior year and healthcare utilization rates in the U.S. increased for the second quarter in a row and are expected to keep […]
New Jersey Governor Chris Christie has formed a political-action committee (PAC) called “Leadership Matters for America.”
Stop the routine use of bone graft substitutes containing recombinant proteins or synthetic peptides high-risk (Class III) medical devices in patients under 18 years of age, warns the Food and Drug Administration (FDA). On January 21, 2015, the agency issued a “Safety Communication – Reports of Serious Injury, ” because reports of serious injuries, “such […]
K2M Holdings, Inc. announced on January 21, 2015 that the FDA granted 510(k) clearance for the company’s MESA 2 Deformity Spinal System. The system is the company’s next-generation pedicle screw system. According to the announcement, the system features the “next-generation MESA 2 screw, a top-loading, low-profile screw that offers a dual-lead thread pattern for fast […]
Robyn Hakanson, M.D. was presented on January 6, 2015 with the Innovator of the Year Award by Medtronic Advance Energy.
Biomet doesn’t seem quite as pretty today as it was when Zimmer came calling last year. Slowing sales and another bribery investigation have added to the anxiety and uncertainty of employees waiting to know if they have jobs. Drue DeAngelis offers another round of advice. Read about the latest state of the upcoming ZimmerBiomet marriage.
ECA Medical Instruments, Inc. claims to have developed a “game changer” with the “potential to transform healthcare economics.” The claim is based on FDA clearance of the company’s disposable spine implant fixation kit announced on January 16, 2015. Calling it the first such sterile-packed kit to gain FDA clearance, the product “features a full complement […]
K2M Group Holdings, Inc. wants more money. On January 20, 2015, the company announced it has filed documents with the SEC “relating to a proposed follow-on public offering of its common stock.” According to the company announcement, it hopes the offering of 4.9 million shares will raise around $40 million. Most of the proceeds, according […]
Israeli-based PolyPid Ltd. has offered a prospectus to raise $18 million-$22 million for an initial public offering (IPO). The company called off a planned NASDAQ IPO in late 2014 and the $18 million-$22 million is about the same amount the company hoped to raise last year. The company has developed a delayed-release drug for treatment […]
Overland Park, Kansas-based Spinal Simplicity, LLC, claims it has the only ISP (interspinous process) fusion device utilizing a percutaneous lateral approach to the spine cleared by the FDA for U.S. patients. On January 9, 2015, the company announced the 510(k) FDA clearance of its Minuteman lateral percutaneous interlaminar fusion device. The Minuteman The device, according […]
Flower Orthopedics Corporation released a new “FlowerCube” anatomic distal radius plate with instruments on January 13, 2015. The company developed the “Ready-for-Surgery” FlowerCube concept which provides implants in individual sterile packaging. According to the company, this eliminates the need for pre-op sterilization and “considerably” reduces the number of implants and instruments brought into the operating […]
If a device manufacturer is accused of lying to the FDA about complying with their regulations and then asks Medicare for reimbursement, a whistleblower is likely to sue the manufacturer under the False Claims Act (FCA). If the whistleblower makes a good case, the government is likely to join in. That’s been the basis of […]
OtisMed Corporation and its former CEO Charlie Chi pled guilty on December 8, 2014 to illegally marketing the OtisKnee device. The company did so in direct violation of an FDA warning not to market the product. Why did they do it? A slew of federal documents tell the story. Read it here.
Zimmer Holdings, Inc. and Biomet, Inc. aren’t the only two companies caught in the gears of regulatory permission to merge. Tornier N.V. and Wright Medical Group, Inc. are also trying to weave their way through the Federal Trade Commission (FTC) waiting period required by the Hart-Scott-Rodino (HSR) Antitrust Improvements Act. On December 30, 2014, Wright […]
Cartiva, Inc. claims to have the first intramedullary hammertoe implant designed to maintain continuous bone-to-bone contact through a unique suture locking system. And now American patients will have access to the company’s ProxiFuse Hammertoes Correction System after the FDA granted the company 510(k) clearance to market the system in the United States. According to the […]
From mega-mergers to small entrepreneurs making their mark. From the antics of a dangerous rogue to the passing of a dear physician friend to us all. From the new world of generics and distribution and musical chairs of device sales reps to the latest in orthopedic science, 2014 was full of orthopedic stories. Here are the best of the best for 2014.
The United States Senate and House of Representatives each have a new Republican physician among their 74 newest members following the recent mid-term elections. If history is any guide, physicians shouldn’t expect Congressman Ralph Abraham, M.D. or Senator Bill Cassidy, M.D. to cast their votes in favor of physician backed legislation such as the “Doc […]
On New Year’s Eve, MiMedx Group, Inc. announced that the feds are conducting a civil investigation of the company’s sales and marketing practices. In an unrelated matter, the company also announced it was suing a competitor, Organogenesis, Inc. for “tortuous interference.” MiMedx develops, processes and markets regenerative biomaterial products and bioimplants processed from human amniotic […]
Stryker Corporation announced on January 5, 2011 that it was acquiring a London-based healthcare company. No, it wasn’t Smith & Nephew and it’s not London, England. The acquisition is London, Ontario-based CHG Hospital Beds, Inc. The company designs and makes low-height hospital beds and related accessories. With over 35 years of experience, the company sells […]
Virginia Governor Terry “The Gator Wrestler” McAuliffe announced on December 12, 2014 that K2M Group Holdings, Inc. will relocate its global headquarters and research and development operations to a new 146, 000-square-foot facility in Leesburg, Virginia. The Leesburg Town Council approved a rezoning request to accommodate the facility back in August and the Virginia Economic […]
On August 2, 2012, the Centers for Medicare and Medicaid Services (CMS) issued a Medicare National Coverage Determination which allows coverage of autologous PRP (platelet-rich plasma) under coverage with Evidence Development (CED) with certain conditions. On December 15, 2014, the agency updated its coverage page for meeting the conditions for applying for approval of a […]
Osiris Therapeutics, Inc. and Stryker Corporation have entered into an exclusive, worldwide partnership for the commercialization and development of Osiris’ viable bone matrix tissue form. Under the agreement announced on December 22, 2014, Stryker has exclusive rights to BIO4, a bone allograft that contains both viable cells and growth factors. According to the announcement, BIO4 […]
Only 10% of 1, 400 surveyed medical students say they want to go into private practice and the percentage of students who will seek a job with a hospital or large group practices has risen to 73%. According to athenahealth, Inc.’s ninth annual Epocrates Future Physicians of America survey released on December 15, 2014, the […]
The first surgical case using K2M Group Holdings, Inc.’s CAPRI Corpectomy Cage System has been completed. The company announced on December 22, 2014 that Stefano Boriani, M.D., at Rizzoli Hospital in Bologna, Italy performed the surgery using the expandable vertebral body replacement device. The device provides structural stability following a corpectomy or vertebrectomy. “Continuous Height […]
The top U.S. patent court has slashed Stryker Corporation’s $228 million damage award from Zimmer Holdings Inc over a surgical cleaning wand to $70 million. That’s a hefty secular holiday gift. Stryker sued Zimmer back in 2010, claiming Zimmer’s Pulsavac Plus device for cleaning wounds during orthopedic surgical procedures infringed three of its patents. A […]
The FDA ortho panel meeting to consider VertiFlex Inc.’s premarket approval (PMA) application for the Superion interspinous spacer system has been moved to February 20, 2015. Apparently the dog ate the FDA’s homework as, according to a December 12, 2014 VertiFlex press release, the meeting was moved by the FDA because they were unable to […]
There is no pretty way to say this. Docs got fooled again. After millions in campaign contributions and revved-up advocacy efforts, docs failed once again to get the lame-duck 113th Congress to provide a “Doc Fix” in its new budget. Congress also failed to extend a pay increase for Medicaid primary care services, and did […]
A December 8, 2014 Wall Street Journal article says the FDA is not disclosing enough financial ties between device makers and physicians serving on the FDA’s expert panels. Panelist Industry Payments The story cited an analysis of corporate, state and federal data sources which showed that from 2012 to 2014, one-third of 122 panel (including […]
Every provider who has ever had a claim denied by an insurer has thought the denial was unfair and was only motivated by the insurer’s greed. Now, six fired employees of WellCare Health Plans say they have proof that medical decisions were being made for financial reasons. Read their allegations here.
Michael Baker, the convicted and sentenced former CEO of ArthroCare Corp. told a Texas federal judge that he should have a new trial because of seating arrangements at his trial. Earlier this summer he was sentenced to 20 years in prison for committing securities fraud. Baker’s lawyers clearly understood the famous law school lesson that […]
On December 12, 2014, the company announced that ResMed Inc. CEO Michael J. “Mick” Farrell and will join the board.
DePuy Synthes Spine has a new device to help kids suffering from thoracic insufficiency syndrome (TIS) take a deep breath. Kids with TIS experience impaired breathing or lung growth. As they grow, the spine and rib cage do not keep pace, resulting in chest wall deformities and sometimes requiring oxygen or ventilator support. The most […]
Orthopedic implant makers, including Zimmer India, Johnson & Johnson, India Medtronic Corporate, Braun Medical India and others have been asked to produce a “slew of documents” by the Indian National Pharmaceutical Pricing Authority (NPPA). According to a December 8, 2014 Pharmabiz.com posting by Ramesh Shankar, the request comes under the NPPA’s authority to monitor price […]
Regenerative cartilage company, Histogenics Corporation, announced the offering of 5.9 million common shares at $11 per share for its initial public offering (IPO). The net offering proceeds from the sale of the shares are expected to be approximately $57.2 million “HSGX” The company shares began trading on the NASDAQ Global Market under the ticker symbol […]
Col. Mohammad Ismail Wardak, M.D., the Afghan orthopedic surgeon who taught us all about the spirit of innovation by inventing the Afghan Knee Device in an old bicycle shop under the noses of the Taliban is looking for some advice from his colleagues. Dr. Wardak put up a Facebook posting on December 9, 2014 which […]
Stryker Corporation announced on December 8, 2014 that it is going to pay almost $80 million to settle a civil and criminal investigation of actions by OtisMed Corp. prior to Stryker’s acquisition of the company in November 2009. OtisMed was formed in 2005. When Stryker acquired OtisMed in 2009, the company did not disclose how […]
The Roberts Court wants a second look at Obamacare. Odds are it may not survive this vote. And in the process two legacies—the President’s and a U.S. Chief Justices’—may well be changed forever. And as that drama unfolds, the medical device tax repeal may well be able to slip through and get to Obama’s desk for signature. Read how.
Japan is beginning to implement a new device regulatory scheme that it hopes beats the FDA in review times and makes it easier for device makers to commercialize their products in the country. Separates Devices From Drugs AdvaMed President and CEO Stephen Ubl applauded the new law which regulates medical devices separately from drugs for […]
Zimmer Holdings, Inc. is offering to divest itself of some knee and elbow brands to get European regulators off the dime and approve their acquisition of Biomet, Inc. “Remedy Package” On December 4, 2014, the company said it has offered the European Commission (EC) a “remedy package” to help get the deal done. According to […]
The Center for Medicare and Medicaid Services (CMS) wants to change the risk/reward equation for Accountable Care Organizations (ACOs) and is offering to sweeten the pot. The agency is proposing to give ACOs an additional three years to get their act together before punishing them for not meeting financial goals. There are now more than […]
DePuy Synthes claims it has launched the first arthroscopic hybrid anchor solution for repair of shoulder and hip instability. The company says its Gryphon Proknot Anchor “combines the control, strength and consistency of traditional anchors with the low profile repair and ease of use of knotless anchors.” The anchor uses “a proprietary pre-tied sliding knot […]
Fighting health care fraud paid off to the tune of $2.3 billion for the feds over the last year. $5.69 Billion Jackpot The U.S. Department of Justice (DOJ) said on November 20, 2014 that for its previous fiscal year it recovered that amount in cases involving false claims against federal health care programs like Medicare, […]
More than 6, 000 doctors and nurses took to Moscow streets on November 23, 2014 to protest the planned closure of at least 28 Moscow hospitals and the firing of up to 10, 000 medical staff, as part of a sweeping overhaul that officials say is needed to modernize a decrepit Soviet-era health system. It […]
“We don’t need no stinkin’ innovation, we need more imitation.” That’s the message from two healthcare leaders in a November 19, 2014 Harvard Business Review article who say providers should focus on existing approaches that actually work and should actively seek out good ideas that have been tried and refined, bring those ideas home, and […]
The Center for Medicare & Medicaid Services (CMS) has assigned a unique Healthcare Common Procedure Coding System (“HCPCS”) code, or J-Code, for Anika Therapeutics, Inc.’s Monovisc product. As a result of getting the J-Code, Anika is receiving a $5 million milestone payment from DePuy Synthes Mitek Sports Medicine, the marketer of the product. The issuance […]
Roger Williams and his accomplices stand accused of bilking California Workers’ Comp payers for millions for overinflated and “counterfeit” pedicle screws. This week we bring you the final scene of Act III of the FBI Spinal Cap drama. See how the plot was allegedly hatched and how the accused are fighting back.
The first and only test specifically designed for the diagnosis of periprosthetic joint infection (PJI), is now eligible for sale in several European countries. On November 19, 2014, Zimmer Holdings, Inc. announced its Synovasure Alpha Defensin test for PJI received Certificate of CE (IVD) Notification and European Authorized Representative (EAR) certificate. According to the company, […]
The European Commission was supposed to make a decision on the ZimmerBiomet deal by March 11, 2015. On November 18, 2014, Zimmer Holdings Inc. announced the company had agreed to extend the European deadline by a “limited number of days, ” and provide the European regulators with additional information. In October, the Commission opened an […]
Medtronic Inc.’s spine’s most recent quarter’s sales beat Wall Street expectations. Most surprisingly, Infuse is credited with causing the surprise. Yes, you read that right. Biologic sales for Medtronic’s second quarter rose 9% on a reported basis while Core Spine and Interventional Spine, which consists of the company’s balloon kyphoplasty product line slipped 1% and […]
Baxano Surgical, Inc. has filed for Chapter 11 Bankruptcy and its assets are going up for auction, according to a company announcement on November 13, 2014. The company was unable to secure ongoing financing, so a decision was made to facilitate a going concern sale of the company’s minimally invasive products under Section 363 of […]
The whistleblower lawsuit that started the FBI Spinal Cap investigation in California has been made public. Michael Drobot is still at the center of this drama. Act III of the drama now unfolds as patients sue Drobot and his accomplices for causing counterfeit screws and rods to be implanted in their spines. Read Part 1 this week.
France-based FH Orthopedics has a new spine unit which just introduced a cervical disc to go along with its elastic artificial disc for lumbar applications. The company announcement on November 5, 2014 says the device, the CP-ESP, has received CE Mark and is available in heights from 5mm to 7mm with three different footprints. The […]
The first patient is enrolled in Zyga Technology, Inc.’s facet DUET clinical study. The company announced on November 11, 2014 that Reginald Davis, M.D. FACS, Chief of Neurosurgery at Greater Baltimore Medical Center, performed the first surgery in the study, a multi-site, single-arm study of the Zyga Glyder facet restoration device in subjects with lumbar […]
There will soon be 32 new jobs in Warsaw, Indiana. On November 14, 2014, company officials from Alpha Manufacturing & Design, LLC, announced a $5.62 million investment to construct and equip a new 12, 000 square-foot addition to the company’s current 5, 000 square-foot facility in Warsaw. The facility, which will be fully operational by […]
The FDA is detaining foreign shipments of leg braces claiming to relieve back pain until the importers and distributors can prove that the braces are compliant with the classification requirements of the 510(k) clearance program. The importers and distributors, Plymouth Direct Inc. and Nature’s Pillows Inc., filed suit in federal court on November 3, 2014, […]
Zimmer Spine is on a roll. After a 6% rise in sales for the third quarter, the company announced on November 10, 2014, the FDA 510(k) clearance of its Optio-C Anterior Cervical Plate for use with structural allograft/autograft as a stand-alone cervical system for cervical fusion procedures. Structural Allograft/Autograft or PEEK Steve Healy, the president […]
The French-based Medicrea Group says it has received FDA 510(k) clearance for its UNiD spinal device, which according to the company, is the world’s first patient-specific spinal osteosynthesis rod to treat degenerative spine conditions including scoliosis. The technology was introduced at the 2014 North American Spine Society (NASS) Annual Meeting on November 12, 2014 in […]
After 22 years of training at Stryker Corporation, including serving as CFO and interim CEO, Curt Hartman is running his own ship.
The federal bone growth stimulation investigations notched another settlement marker on October 29, 2014. While not admitting any liability, Biomet Inc.’s EBI LLC agreed to pay $6.07 million to resolve allegations that EBI violated the False Claims Act (FCA) by paying kickbacks to induce use of its OsteoGen bone growth stimulators and billing federal healthcare […]
It’s been a tough few weeks for RTI Surgical, Inc. First, in October the FDA challenged the company over the definition of “minimal manipulation” and then the British-based tabloid the Mail on Sunday published a story on Sunday, November 2, 2014 that alleged that RTI was linked to “the illegal trade in human remains in […]
Kevin Lobo, Stryker’s CEO and his Lieutenant, Katherine Owen, outperformed Wall Street’s expectations and hit a $1 billion quarterly milestone. With smaller acquisitions and a big get on robots and ankles, the company is laying the foundation for a notably bright future. Read what they told analysts.
“Obamacare, ” the Affordable Care Act, will not be “repealed or fundamentally changed” by the next U.S. Congress. That’s what Robert Laszewski of Health Care Policy and Marketplace Review and one of our favorite insurance and healthcare reform experts says after Republicans took over the U.S. Senate in midterm elections on November 4, 2014. He’s […]
Stryker Corporation and lawyers representing patients suing the company over its metal-on-metal Rejuvenate Modular-Neck and ABG II Modular-Neck hip implants have settled the claims for approximately $1.4 to $2.3 billion. Stryker voluntarily conducted a worldwide recall of the products in July 2012. According to a November 3, 2014 company announcement, Stryker has recorded charges totaling […]
Meet the new Zimmer Biomet and its leaders. Zimmer Holdings, Inc. is feeling so confident of regulatory approval of its merger with Biomet, Inc. that the company announced what the combined company will be called after the merger is completed. On October 30, 2014, the company also announced the future executive leadership team and organizational […]
A federal jury gives DePuy Orthopaedics a big court victory in the second big metal-on-metal hip implant set of lawsuits. After settling the ASR hip case for $2.5 billion, the company is digging in its heels over 6, 000+ Pinnacle implant lawsuits. But the Vioxx slayer representing the plaintiff won’t give up easy.
Zimmer Holdings, Inc. had $1.11 billion in sales during the third quarter of 2014. That’s up 2.9% over last year’s third quarter. The company beat Wall Street expectations by about $10 million. After accounting for currency, the company expects reported revenue growth for the full year of approximately 1.50%. David Dvorak, Zimmer’s president and CEO […]
Biomet, Inc., through its 2013 acquisition of Lanx, Inc., received the first FDA 510(k) clearance for a modular plating and hyperlordotic spacer system designed to help facilitate acute sagittal correction via the lateral approach when used in conjunction with supplemental fixation. On October 21, 2014, the company announced that the first surgery using the system. […]
Over the past ten years, PEEK (polyetheretherketone) has largely replaced titanium as the material of choice for orthopedic implants. But now, Medtronic, Inc. is marrying the two materials together, calling it an “evolution in interbody fusion technology” by constructing devices made with a combination of the two materials in a “Pure Titanium Coating” (PTC) platform. […]
Medtronic, Inc. has launched a new anterior fusion system that the company says makes the ACDF (anterior cervical discectomy with fusion) procedure more efficient for the surgeon and less invasive for the patient. The Divergence system had its U.S. launch on October 21, 2014 at the Congress of Neurological Surgeons (CNS) Annual Meeting in Boston. […]
“The world’s top doctors at your fingertips, from the comfort of your own home, ” boasts the latest Internet online concierge medical services for patients. “We provide priority access Telehealth Consultations & Second Opinions from the world’s leading doctors.” There’s just one catch. You have to self-pay. On October 8, 2014, HelloMD announced the release […]
Johnson & Johnson’s DePuy Synthes’ orthopedic sales increased 2.7% to $2.344 billion during the third quarter of 2014. Currency cut revenues by 0.2%. Hip Prices Cut The company cut hip prices by 5% during the quarter but still logged a 4% increase in hip sales. Knee sales jumped 6% and trauma sales rose 3%. Only […]
The definition of “minimal manipulation” of cells is rearing its head again as the FDA has sent RTI Surgical Inc. (RTI) a letter regarding the company’s map3 cellular allogeneic bone graft. “Altering Characteristics” An October 9, 2014 letter sent by Mary A. Malarkey, Director Office of Compliance and Biologics Quality Center for Biologics Evaluation and […]
A U.S. Court of Appeals called the actions of the FDA unlawful and exonerated ReGen Biologics of accusations of misconduct. Short of misconduct, the FDA has no power to rescind the 510(k) clearance of the company’s Menaflex collagen scaffold, said the Court. What does this all mean for your next encounter with the FDA? Read it here.
The “FDA 9” whistleblowers who accused the FDA of spying on them have had their lawsuit tossed out by a federal judge in Washington because they did not exhausted all other administrative avenues of redress within the FDA. According to an October 3, 2014 story in Mass Device, Judge Reggie Walton ruled on September 23, […]
Biomet, Inc.’s most recently completed quarterly sales rose 6% over the same quarter last year. Wall Street analysts pore over Biomet’s results like gypsies reading tea leaves at the bottom of the tea cup to divine where orthopedic sales for the entire industry are heading. The leaf reading will come to an end soon as […]
Orthopedic hospitals are now on Medicare’s radar and will begin receiving penalties for readmissions. $428 Million Penalties In the next year, over 2, 600 hospitals are going to lose $428 million in expected payments from Medicare as a penalty for having too many patients return within a month for additional treatments. That’s 496 more hospitals […]
Zimmer Holdings, Inc. has gotten its hands on breakthrough technology in biomimetic calcium phosphate, which mimics the chemical and structural features of human bone, promotes natural bone regeneration. On October 1, 2014, the company announced it was acquiring Cambridge, Massachusetts-based ETEX Holdings, Incorporated. ETEX was founded in 1989 by Harvard Dental School researcher Dosuk Lee. […]
European Union (EU) antitrust regulators are opening an in-depth investigation into the Zimmer Holdings, Inc. /Biomet, Inc. merger. Reuters, quoting “unnamed people, ” reported on October 2, 2014 that the European Commission, which has been reviewing the deal since August, will open the “in-depth investigation” because of concerns that the deal may reduce competition. The […]
Ready or not and 33% incomplete, CMS (Centers for Medicare and Medicaid Services) released the first round of Open Payments data on September 30, 2014. The big news? Big Pharma Rules We did a quick review of the 4.4 million payments for a total of $3.5 billion paid to 546, 000 individual physicians and almost […]
The legal battle over PODs is getting heated. The lawyers are starting to threaten sanctions and lecturing each other over ethics. Pat Hooper, the lawyer for the defense is demanding to see the evidence. We obtained the latest exchange between the combatants. No anonymous leaks, just a very public battle.
The government’s healthcare cop, the DOJ, says Reliance Medical violated the Anti-Kickback Statue of the False Claims Act. Rubbish, says Reliance’s lawyer, Pat Hooper who beat the DOJ the last time they went after physician owned entities. He says the government’s just coming back for a second bite of the apple. Read how he is defending his clients and PODs.
The FDA’s Orthopaedic & Rehabilitation Devices panel is planning to meet on December 12, 2014 to consider VertiFlex Inc.’s pre-market approval application (PMA) for the company’s Superion ISS (interspinous spacer). Compared to X-STOP Company President and CEO Earl Fender says the panel is going to see evidence from the “largest and most rigorous FDA trial […]
Medical societies are reporting that physicians who are waiting until October 15, 2014 to file their 2013 tax returns are being targeted at higher-than-normal rates of a tax fraud scheme involving phony tax returns. In June the Texas Medical Association reported that more than 100 of their members notified the association someone had stolen their […]
Is Biomet, Inc., CEO Jeff Binder going to China? Xinrong Best Medical Instrument Co. Blackstone Group LP, the lead Wall Street banker in the Biomet, Inc. private equity ownership group, announced on September 23, 2014 that it was acquiring an “unspecified” stake in China’s Xinrong Best Medical Instrument Co. Xinrong is a Chinese-based developer of […]
The government has fired the first legal shot against physician-owned distributors (PODs) by filing a False Claim lawsuit against Reliance Medical, two PODs and Aria Sabit, M.D., an investor in the PODs. The suit says the group sailed outside Safe-Harbor waters and therefore filed false Medicare claims. The government wants its money back.
Implementation of the Sunshine Act through the CMS (Centers for Medicare and Medicaid Services) Open Payments program goes into effect on September 30, 2014. The heads of Big Pharma, biotechnology and medical devices aren’t happy about that and want CMS to stop publishing physician payment information until industry has a chance to suggest and secure […]
Stryker Corporation buys MAKO Surgical. Smith & Nephew signs a deal with Blue Belt Technologies, Inc. while Blue Belt and MAKO duke out disagreements in court. Then OMNIlife Science, Inc. announces they’ve now done 4, 000 total knees using their OMNIplasty procedure. The orthopedic robot wars got even more interesting on September 17, 2014, as […]
Medtronic, Inc. is introducing the next generation of its Kyphon cement delivery system. On September 17, 2014, the company announced the launch of the Kyphon Express II Balloon Kyphoplasty Platform for the treatment of vertebral compression fractures (VCF). The first generation system came to Medtronic in 2007 when the company paid $4.2 billion for the […]
Lawyers representing plaintiffs in the NexGen lawsuits say Zimmer Holdings, Inc.’s claims that they should be sanctioned shows the company is running scared. In its motion to sanction the lawyers, Zimmer noted that attorneys representing plaintiffs Mertha Shoat, Ronnie Davis and Debra Teague had missed a July 15 deadline for producing expert reports without providing […]
Ortho Kinematics, Inc. (OKI) and Medtronic, Inc. have joined up to promote OKI’s Vertebral Motion Analysis (VMA) test to spine surgeons. Vertebral Motion Analysis Test The VMA is a diagnostic test for the spine that uses fluoroscopy to capture the spine in motion, producing patient-specific graphs for each vertebral level. A September 16, 2014 announcement […]
Recent actions by Chinese officials to promote China-made orthopedic devices, raise regulatory hurdles for outsiders, propose a ban on brand names, resort to anti-trust bullying and allegedly promote cyber-attacks on U.S. companies smacks of protectionism if not an all-out trade war. Who are the combatants? Is there a trade war?
Over 4, 000 total knee replacements have been completed in the U.S. using OMNIlife Science, Inc.’s OMNIPlasty technique. Total Knee Procedure OMNI’s system performs a total knee procedure that uses robotics utilizing the company’s OMNI ART software platform. Surgeons can plan and execute a procedure that is specific to each patient using a patented intra-operative […]
Zimmer Holdings, Inc. is fighting back against plaintiffs’ attorneys who filed lawsuits on behalf of patients implanted with the company’s NexGen knees. The company asked U.S. Federal District Judge Rebecca Pallmyer in Northern Illinois to sanction three attorneys for plaintiffs in the multi-district litigation overseen by the judge. According to an August 28, 2014 article […]
Paul Slosar, M.D., says it’s the first time in his experience that a device company in the spine market has offered a warranty for its devices. One-Time Free Replacement On September 8, 2014, Mequon, Wisconsin-based Titan Spine, LLC announced it is offering a warranty for its Endoskeleton line of spinal interbody fusion devices. Through the […]
In what is believed to be the first settlement of its kind, Smith & Nephew plc has agreed to pay $11.3 million to settle a whistleblower lawsuit that accused the company of violating the Trade Agreements Act (TAA). Made in Malaysia Sam Cox, a former Smith & Nephew information technology manager filed a qui tam […]
Medicare spending will be slower in 2014 than originally projected, says the Congressional Budget Office (CBO) in a mid-year report. The news is reigniting efforts to repeal the sustainable growth rate (SGR) physician payment system. In an August report titled “An Update To The Budget And Economic Outlook: 2014 to 2024, ” the CBO reported […]
The romancing of Biomet by Zimmer in the small town of Warsaw, Indiana, is a tale of courtship, coyness, teasing and attempts of getting that kiss from the girl down the street. How did this engagement come about? Zimmer’s SEC filing tells all.
The largest-ever single-day medical device recall has been reported by the FDA. Sterility Loss On August 26, 2014, the FDA posted 233 Class I recalls, all for sterile convenience surgical packs devices manufactured by Puerto Rico-based Customed, Inc. The packs were found to have a potential defect due to adhesion. The defect could result in […]
Medtronic, Inc. has received FDA clearance for a growth guidance system that can avoid having to fuse kids with a severe form of scoliosis. SHILLA Growth Guidance System Richard McCarthy, M.D., the inventor of the SHILLA Growth Guidance System, said on August 28, 2014: “The current gold standard technique to manage scoliosis long-term is to […]
The leaders of the DiscoCare scam are going to jail. Baker, Gluk, Raffle and Applegate Michael Baker, the former CEO of ArthroCare Corporation was sentenced to 20 years in prison on Friday, August 29, 2014, for leading a $750 million securities fraud scheme. Michael Gluk, the company’s former chief financial officer was sentenced to serve […]
MESA Hooks, made by K2M Group Holdings, Inc., have been cleared by the FDA for sale in the U.S. The company announced on September 2, 2014 that the hooks are the latest implant addition to the MESA Deformity Spinal System. K2M also received the CE Mark for the hooks. The MESA Hook extension to the […]
DePuy Synthes is recalling its Craniomaxillofacial (CMF) Distraction System (AB Distractor Bodies and BC Distractor Bodies) because infants are in danger of dying due to the failure of the device. The system, also called an External Mandibular Fixator and/or Distractor and Bone Plate, is being recalled because the device may reverse direction and lose the […]
Insurers and Medicare are rushing into “Pay-for-Performance” at breakneck speed. Paying for outcomes is supposed to save money and improve patient care. Physicians don’t believe it. They want to see evidence that patients are benefiting. What is the evidence? We take a look.
Game, set, match. Arthrex, Inc. has scored a double bagel patent victory over Parcus Medical, LLC. When several former high-level Arthrex executives left the company in 2007 to sell less expensive “generic” arthroscopic products, they took proprietary information with them. Arthrex sued them in December, 2001 for patent infringement. On August 26, 2014, Arthrex announced […]
Zimmer Holdings, Inc. says it has the only laboratory tested hip replacement technology that mimics the number of steps a person will take during their lifetime following hip replacement surgery. While not exactly a warranty, Zimmer said on August 22, 2014, that it believes its Vivacit-E Vitamin E highly crosslinked polyethylene (HXPE) liner is the […]
Globus Medical, Inc. is suing a former distributor, Louisiana-based Vortex Spine, LLC and its owner James Long, for “fraudulent and unfair competition.” The company claims Long acted as a “double agent” who sold Orthofix International, N.V. spine products to Globus customers in Louisiana. They also accuse one of Long’s employees of selling Biomet, Inc. spine […]
The reports of the death of the device salesperson have been greatly exaggerated. What is the role of the great medical salesperson? The granddaddy of them all reminds us. Read it here.
Arthrosurface, Inc.’s KISSloc Suture System has been given FDA 510(k) clearance. According to an August 25, 2014 company press release, the system is a mini plate and suture implant intended for the correction of a hallux valgus (bunion) deformity. It consists of two low profile plates and a self-cinching suture construct which reduces the intramedullary […]
Stryker Corporation has dropped a patent infringement lawsuit against DePuy Orthopaedics, Wright Medical Technology, Inc., Zimmer Holdings, Inc. and Smith & Nephew, plc. The 2011 lawsuit was over a patent for a hip implant component. Stryker accused its competitors of violating a Stryker patent for “Acetabular Cup Assembly With Selected Bearing, ” according to court […]
Chinese spine surgeons have performed the world’s first 3D printed vertebra surgery. According to an August 8, 2014 report on CCTV.com, surgeons at No. 3 Hospital, Peking University, replaced the second vertebra in a 12-year-old boy’s neck after developing cancer in the bone. The boy had been lying in the orthopedics ward for more than […]
Medtronic Inc.’s spine business lost more market share in the past quarter as spine revenue declined in a growing market. While overall corporate sales were up 4% to $4.27 billion, spine sales of $743 million declined 3%. Declines in core spine and biologics were offset by growth in interventional spine. Core spine sales fell 2% […]
The Centers for Medicare and Medicaid Services (CMS) is returning one-third of the records submitted by device and drug makers under the Physician Payments Sunshine Act. The agency told ProPublica on August 15, 2013 that there too many errors and might even level fines if further mistakes are made. The remaining two-thirds of the records […]
A complaint from a physician about inaccurate payment information reported by device makers shut down the CMS (Centers for Medicare and Medicaid Services) Open Payment System temporarily in early August. The Open Payments System website is where healthcare manufacturers report payments to physicians. The system was taken offline on August 3 to resolve a technical […]
Two former Integra LifeSciences Holding Corp. employees have pled guilty to defrauding hospitals of more than $800, 000. Dan Metz was a Northeast regional manager for Integra LifeSciences until he was terminated in April 2013. Charles Carey, Jr. reported to Metz as a product specialist until he resigned in April 2011. On August 12, 2014, […]
Biomet UK Ltd wants hospitals that have the Mallory-Head 6 Hole Shell HA/PC implant used in hip replacements to discontinue using the shell due to a manufacturing error. In an August 1, 2014 “Field Safety Correction Action, ” Richard Castaneda, UK Quality and Regulatory Compliance Director for Biomet UK, wrote that following a complaint, Biomet […]
OsteoSelect works as well as autologous bone in a rabbit posterolateral spinal fusion model. Gregory Juda, chief scientific officer for Bacterin International Holdings, Inc., the maker of OsteoSelect said a study, published in The Spine Journal, completed at the Integrated Spine Research Department at the Hospital for Special Surgery in New York, has, “shown equivalency […]
Urgent care centers are a thriving $14.5 billion industry. But dedicated orthopedic centers are just a fraction of that market. From Tria Orthopaedics in Minnesota to Alejandro Badia, M.D.’s OrthoNOW franchise model in Miami, ortho surgeons are finding another way to capture the patient and remain independent from hospitals. Read what we found.
Bacterin International Holdings, Inc. has raised $6.5 million in a common stock offering. The company announced on August 6, 2014 that the successful public offering of 1.143 million shares at $5.70 has been completed. The funds will be used to expand the sales force and the increasing inventory needed to meet expected market demand. Bacterin […]
Payments from CMS (Centers for Medicare & Medicaid Services) to hospitals will decline by $756 million for 2015. Payments for orthopedic DRGs (diagnostic related groups), according to Wells Fargo analyst, Larry Biegelsen were up 0.3% vs. the final 2014 rule. On August 4, 2014, the agency issued their 2015 Inpatient Prospective Payment System (IPPS) 2, […]
FDA medical device user fees are going down by 3%. Medical device companies pay the fee to have their products reviewed by the agency. The cuts are for the government’s 2015 fiscal year. The CDRH (Center for Devices & Radiological Health) division of the agency said on July 30, 2014, it proposes to cut the […]
The Journal of Foot and Ankle Surgery has published clinical results of Bacterin International Holdings, Inc.’s OsteoSponge SC Allograft that show positive clinical outcomes at two years post-op. The study, “Role of Demineralized Allograft Subchondral Bone in the Treatment of Shoulder Lesions of the Talus: Clinical Results with Two-Year Follow-up, ” followed the use of […]
Smith & Nephew, plc (SNN) expects to cut some orthopedic implant prices in half with a “no-frills” option called Syncera that excludes logistical support or an onsite technician and replaces them with an iPad app. The program was announced by company CEO Olivier Bohoun at the end of July. Bohoun said the Syncera program could […]
What’s it take to herd surgeons into the world of pay-for-performance? Two health system leaders prescribe some tough medicine to convince surgeons to get on board. The good news is that when the medicine works, surgeons stay in charge. If not, they’re fired. Get your prescription here.
Medtronic, Inc.’s Prestige LP cervical disc has received FDA PMA (premarket application) approval. The company announced on July 28, 2014, that the device is the third artificial cervical disc in the Medtronic’s portfolio to receive FDA approval. The original Prestige disc was introduced in 2007. The FDA has approved four other cervical discs since 2012. […]
Zimmer Holdings, Inc.’s second quarter revenue of $1.18 billion disappointed some Wall Street analysts, missing consensus by about $25 million. Revenue for the quarter only climbed 1% on a reported basis. Reported sales in the Americas were particularly weak, declining by 2.7%. Sales in Europe were up 4.9% and up 7% in Asia/Pacific. Respectable […]
DePuy Synthes continues its cost-cutting measures. According to a July 17, 2014, Wall Street Journal Pharmalot blog, the company is eliminating all travel for the rest of the year. The sales force is exempt. It was also reported that all consulting contracts valued at more than $50, 000 must now obtain top-level approval. The Journal […]
Cheryl Blanchard, Ph.D., Zimmer Holdings, Inc.’s former chief science officer, has been appointed CEO of MicroCHIPS, Inc. She also becomes a board member of the company.
Stryker Corporation’s second quarter 2014 reconstructive revenue increased by a reported 6.5% to $1.03 billion. On a reported basis, knees rose 2.7%, hips up 2.3%, trauma and extremities up 11.8%, while spine fell 1.6%. Knees in the U.S. were up 7.1%. Hips also did well in the U.S., climbing 6.3%, but international sales were sluggish. […]
DePuy Synthes reported sales of $2.469 billion during the second quarter of 2014, beating consensus of $2.45 billion. Excluding currency, sales were up 3.3% over the previous year’s quarter. Strong Hips, Weak Knees Hips were strong, rising 5%, while knees were weak, climbing only 1%. During a conference call with analysts on July 15, 2014, […]
More cases are emerging from the FBI’s “Spinal Cap” investigation. Now the allegations are around unapproved spine devices, bribed docs and elected officials, and tragically, a dead baby. It all started with the flawed California workers’ comp law and the ways in which administrators, surgeons and companies tried to game the system.
Zimmer Holdings, Inc. is recalling 41, 180 stemmed tibial components of the NexGen Complete Knee Solution system. According to an FDA Enforcement Report for the week of July 9, 2014, the company is initiating a voluntary recall of specific identified lots “due to the potential that the threads may be out of specification.” The recall […]
While the orthopedic world focuses on the big deals of scale, the Viscogliosi Brothers and Stryker Corporation strike a deal focused on clinical innovation. Stryker is buying Small Bone Innovations and the STAR Ankle for $375 million. After lots of roadblocks, the V Brothers do it again. Tony Viscogliosi tells us how it was done.
Fifty-one percent of Millennials have a favorable view of the Affordable Care Act (ACA), also known as Obamacare; while 46% have a negative opinion. Accounting for partisanship and race, Democratic, independent, and non-white Millennials’ unfavorable views of the President correspond with unfavorable views of the ACA, and vice versa. According to a new Reason-Rupe survey […]
Biomet, Inc.’s revenue grew by 7.7% in the past quarter. The company also reported net income of $67 million, a turnaround from a loss of $221 million a year earlier. The company turned a profit just in time to be acquired by Zimmer Holdings. Inc., scheduled for early 2015. Biomet’s knee sales rose 5.1%, hips […]
Smith & Nephew, plc (S&N) is joining the march of ortho robots by teaming with Blue Belt Technologies, Inc. The partnership, a world-wide commercial agreement between the companies, was announced on July 10, 2014. Blue Belt will support S&N’s Journey UNI knee system in Blue Belt’s Navio surgical system. The Navio system has an open-implant […]
At the 11th annual meeting of the Cabo Spine Technology Group, David Jacofsky, M.D., blew apart a decade of surgeon “doom and gloom” by showing surgeons a formula to retake control of medical decisions. In the process, he inspired a new generation of surgeons to embrace their futures. Here’s “The Formula.”
Questionable sales and marketing efforts in Latin America continue to dog Biomet, Inc. The Securities and Exchange Commission (SEC) has sent Biomet a subpoena to investigate possible improprieties in Mexico and Brazil. The government is also looking at a potential violation of the company’s current Deferred Prosecution Agreement (DPA) and Consent Order with the government. […]
Citing “seismic shifts” in the healthcare environment and a need to reorganize, Michael Orsinger, head of Johnson & Johnson’s orthopedics business announced the elimination of approximately 400 jobs in the DePuy Synthes unit. Orsinger made the remarks in an internal video message to employees on July 2, 2014. A J&J spokeswoman said the majority of […]
Patients with spinal stenosis who received epidural injections with a combination of steroid (glucocorticoid) and local anesthetic (lidocaine) did not improve any better than patients who only received lidocaine injections. Those are the findings of a new study led by Janna Friedly, M.D., a professor of rehabilitation medicine at the University of Washington. It was […]
The Federal Trade Commission (FTC) has sent Zimmer Holdings, Inc. and Biomet, Inc. a “Second Request” for additional information in connection with their proposed merger. According to former FTC attorney Darren Tucker, only about 4% of all deals receive a formal second request for information. Tucker worked on the Johnson & Johnson/Synthes merger while at […]
Are device manufacturers trying to report physician payments on the CMS Open Payments web site experiencing similar problems insurance enrollees experienced when they tried to sign up for Obamacare? It appears there are problems as the Centers for Medicare and Medicaid Services (CMS) help desk announced the agency will not enforce penalties for non-compliance until […]
Zimmer Spine, Inc.’s Virage OCT Spinal Fixation System, an Occipital-Cervico-Thoracic spinal implant system, “will change surgeons’ perspective of posterior fixation.” That bold statement was made by company officials on June 30, 2014, as they announced the U.S. market launch of its new spine system. Changing surgeon perspective is a tall order. Andrew Park, M.D., director, […]
Health insurance stocks jumped in 2013 moments before the government announced Medicare payment news that was favorable to those companies. Did congressional staffers illegally pass along nonpublic information about health policy to their Wall Street trading buddies? Prosecutors from the Justice Department think so and are gathering evidence for a grand jury probe. The Securities […]
It’s been more than 60 days since Zimmer announced it was acquiring Biomet. The FTC has 30 days to decide if they want to block the deal. What’s happening? The former FTC antitrust lawyer who negotiated the consent decree which allowed Synthes and DePuy to merge, gives his opinion. Read it here.
Olympus Biotech Corporation has put a fork into its efforts to commercialize OP-1. After paying $60 million to Stryker Corporation in 2010 for the biologic product that has snake-bitten everyone who has attempted to commercialize the protein, Olympus announced on June 18, 2014 that it will close its 120-employee manufacturing plant in West Lebanon, New […]
Global Orthopaedic Technology is the largest Australian-owned orthopedic implant designer and manufacturer. On June 23, 2014, The Riverside Company announced the acquisition of the manufacturer. Andrew Fox-Smith, a former international group president with Stryker Corporation will serve as the new CEO of the company. Duncan Lilley, who will serve as COO, has held senior roles […]
When Congress passed the Food and Drug Administration Safety and Innovation Act in 2012 to reauthorize the FDA to collect user fees from device manufacturers, the FDA and the medical device industry agreed to an independent, comprehensive assessment of the agencies medical device submission review process. That assessment has been completed and recommendations have been […]
The FDA’s collective heads are in the clouds when it comes to “Big Data.” And the agency wants you to get on their cloud. openFDA On June 2, 2014, the agency launched openFDA, a system designed to make it easier for web developers, researchers, and the public to access and use health data sets collected […]
Christian Joly is OMNIlife science, Inc.’s new vice president of Robotics and Navigation.
Boeing and healthcare providers in the Seattle area have dumped the insurance middle man. On June 13, 2014, the giant aerospace company and two accountable care organizations (ACOs) formed by UW Medicine and Providence Health & Services and Swedish Health Services, formed a partnership to provide care for the employer. No insurance company is involved. […]
A federal judge in Pennsylvania ruled on June 5, 2014 that John Marotta, a former Synthes, Inc. regional manager, breached his non-compete agreement with the company when he left to take over Emerge Medical Inc., a generic device maker. A jury has yet to decide whether Marotta’s actions constituted unfair competition. Marotta left Synthes in […]
Five Stryker sales reps in Northern California went AWOL on April 4, 2014. Before Stryker knew what happened, the five reps had resigned, gone over to DePuy Orthopaedics and brought their business with them. Stryker’s business was decimated in the area so they sued the reps and DePuy for damages.
Physicians seek out information from device manufacturers about off-label uses for their patients. The FDA offers little guidance on exactly what constitutes promotion of medical devices. With that, a Special Litigation Committee formed by the Medtronic, Inc. Board of Directors determined there was no evidence that the company promoted Infuse in an off-label manner. Shareholder […]
The FDA wants to establish five categories of Class III devices. After complaints from stakeholders that the original deadline of June 23, 2014 did not allow for enough time to analyze and respond to the proposal, the agency backed down and extended the deadline to comment on the proposed rule on classification and reclassification until […]
The world’s first spinal fusion surgery using customized spine cages created with a 3-D printer was performed on May 28, 2014 by Vincent Fiere, M.D. at the Hospital Jean Mermoz in Lyon, France. The operation, according to a news release from French-based MEDICREA group, used the company’s UNiD ALIF intersomatic anatomical inter-body device. Design, Record […]
Life is good at the top of the healthcare food chain. The chief executives of the 11 largest for-profit insurers earned more than $125 million in total compensation in 2013. Aetna’s Bertolini Wins Of the 11 insurers—Aetna, Centene, Cigna, Health Net, Humana, Molina, Triple-S Management Corporation, UnitedHealth, Universal American, WellCare and WellPoint—Aetna CEO Mark Bertolini […]
In a puzzling legal move Humana Inc. filed suit against Medtronic, Inc. and is trying to invoke the organized crime inspired RICO statute. Humana accuses Medtronic of conspiring with secretly paid surgeon agents to cook peer-review literature and then promote the off-label use of Infuse. Their evidence? The Spine Journal, the U.S. Senate and Yale’s YODA study.
DePuy Synthes Joint Reconstruction introduced three products for hip, knee and shoulders replacements on May 22, 2014. Shoulder According to a company press release, the Global Unite Platform Shoulder System now has anatomic components which “enables surgeons to use the same humeral stem to repair shoulder fractures or perform a total (anatomic) shoulder replacement. For […]
Active Implants, LLC has been granted Investigational Device Exemption (IDE) approval by the FDA to conduct a pivotal clinical trial for its NUsurface Meniscus Implant. The study is a prospective, randomized, multicenter study to demonstrate superiority of the device compared to the current standard-of-care for patients with persistent knee pain following meniscectomy surgery. Elliott Hershman, […]
Bloomberg reported on June 4, 2014 that Medtronic, Inc. is joining Stryker Corporation in evaluating a purchase of Smith & Nephew plc (S&N). Medtronic management quickly threw cold water on that report at a Wall Street analyst meeting on June 5. According to “people familiar with the matter, ” Bloomberg reported that a takeover could […]
Michael Baker and Michael Gluk have been found guilty of fraud by a federal jury in Austin, Texas, for their part in ArthroCare Corp. shareholders losing over $400 million in value in 2008. Baker was immediately taken into custody, pending sentencing. Fraud and False Statements Baker, the former company CEO, and Gluk, the former CFO, […]
America’s medical device trade association, the Advanced Medical Technology Association (AdvaMed) has opened an office in Shanghai, China. The trade group announced on June 2, 2014, that Chinese authorities approved their application to open the office in the city where many AdvaMed members have their China headquarters. Opening the office will “provide AdvaMed members to […]
A small hospital in California performing half a billion dollars in spine surgeries over six years became the target of an FBI investigation called, “Spinal Cap.” This story has it all. Tens of millions in illegal kick-backs, public corruption, device sales schemes and one businessman who pled guilty to it all. Read it here.
FzioMed, Inc.’s hearing with the FDA’s Dispute Resolution Panel for its Oxiplex PMA (premarket approval) application has been postponed. The hearing was scheduled for June 10, 2014. The company announced on May 28, 2014 that the Office of Device Evaluation (ODE) is going to take more time to review additional clinical information. OUS Data The […]
Medtronic Inc.’s overall spine sales declined by 2% to $786 million during the company’s previous quarter. During a call with Wall Street analysts on May 20, 2014, company leaders said with core spine sales growing, they are counting on the stabilization of kyphoplasty and Infuse to get them back to overall growth. Core Spine Business […]
Getting into bundled orthopedic services with a commercial insurer is like getting into a swimming contest with a shark. To win in this contest you need to strap on a 2-stroke direct injection Evinrude E-Tec! We’ve got one for you this week in the form of Hoag Orthopedic Institute’s bundle manager, Gabrielle White. Vroom, Vroom!
Stryker Corporation is evaluating a purchase of Smith & Nephew plc (S&N). However, in response to a United Kingdom regulator request to declare the company’s intentions, Kevin Lobo, Stryker’s CEO, said there would be no bid for the company…today. Lobo even went on Fox Business News on May 28, 2014 to confirm that the company […]
Kinamed Inc.’s SuperCable Iso-Elastic Polymer Cerclage System has been cleared in Japan by the Ministry of Health, Labour and Welfare. According to a May 12, 2014 company press release, the cable system is the only iso-elastic, polymer cerclage system in the market anywhere in the world. It is used in a wide range of orthopedic […]
Ceterix Orthopaedics, Inc. has raised $18 million in a new round of funding to expand the market for its minimally invasive surgical tools. The technology enables surgeons to place stitches in very tight joint compartments, while protecting sensitive surrounding structures such as nerves, arteries and cartilage. This technology has applications in numerous procedures in knees, […]
A jury has awarded bone cement maker Pabban Development $15.4 million after finding that Medtronic, Inc. didn’t hold up its end of the deal to acquire Pabban’s Natrix system. In August 2008 the Federal Trade Commission ruled that Medtronic would have to sell off a Kyphon bone cement delivery system in order to get permission […]
Dave Dvorak and Jeff Binder (the CEOs) tell their sales reps in a May 20, 2014 letter that it is their intention to retain all sales rep positions when their companies, Zimmer Holdings, Inc. and Biomet, Inc. merge in 2015. We reviewed the letter from a regulatory filing. Judging by the overwhelming response by OTW […]
Alicia Napoli, the former clinical & regulatory vice president of Wright Medical Technology, Inc. is suing her former employer for breach of contract, according to a 10-Q SEC regulatory filing issued by the company on May 1, 2014. As we previously reported, Napoli was part of the group of employees who left the company in […]
There is a new excuse for not repealing the medical device tax; Zimmer Holdings, Inc.’s purchase of Biomet, Inc. U.S. Senate Democrat Majority Leader Harry Reid of Nevada reportedly said recently that he would block a Republican demand to vote on repealing the tax. According to rollcall.com, Reid said on May 13, 2014: “I’m not […]
Medical device companies paid the FDA $96.8 million in user fees during fiscal year 2013, up 48% from the previous year. What is industry getting for that extra money? For one thing, according to an agency quarterly report, the percentage of premarket approval (PMA) applications approved by the agency grew from 59% in 2010 to […]
K2M Group Holdings, Inc. went live on NASDAQ on May 8, 2014 and is trading under the symbol “KTWO.” The company’s initial public offering (IPO) pricing was at $15 per share for approximately 8.8 million shares. According to a company announcement, the IPO was to net approximately $120 million. A few days after the listing, […]
The sign-up period to buy healthcare insurance under Obamacare has closed. Partisans spin the numbers into smoke and mirrors. The data sheds light. What does it mean for orthopedic companies? What’s happening to utilization and pricing? Who is happy and sad? We got out our flashlight.
The North American Spine Society (NASS) is taking on the Milliman Care Guidelines and inappropriate insurance coverage denials by issuing its first of 13 coverage recommendations for spine procedures. The recommendations are being distributed to other medical societies and 152 insurance entities. This is the society’s first attempt to proactively write coverage recommendations to counter […]
NuVasive, Inc. announced on May 6, 2014 that the company reached a settlement agreement with Cadwell Laboratories, Inc., in a lawsuit involving NuVasive’s patented neuromonitoring technology. NuVasive sued Cadwell in 2012 over alleged infringement of NuVasive’s technology, including the integration of nerve monitoring technology during lateral approach spine surgery. As part of the settlement reached […]
The proposed 2015 Inpatient Prospective Payment System (IPPS) for Medicare services paid to hospitals was released by Centers for Medicare and Medicaid Services (CMS) on April 30, 2014. Comments will be taken by agency until June 30, 2014, with a final rule issued by August 1. With more surgeons becoming employees of hospitals, these proposed […]
Mark Heggestad is taking over the books at Orthofix International N.V. Heggestad will replace the Interim CFO David Ziegler on May 9, 2014. Ziegler has been the company’s interim CFO since April 21, 2014. Ziegler succeeded Emily Buxton who voluntarily resigned from the company. Buxton had been named interim CFO in October 2012 and given […]
Medtronic, Inc. has agreed to pay $22 million to settle Infuse liability claims with 950 claimants. That averages out to about $23, 000 per case. The announcement on May 6, 2014, stated that approximately 750 filed cases brought by approximately 1, 200 individual plaintiffs remain pending in various courts throughout the U.S. The majority of […]
The great historian, David McCullough, told a North American Spine Society audience a few years ago that there is nothing inevitable about history. History is made by people who make the best decisions they can with no visibility of the future. Only their character guides their decisions. It wasn’t inevitable almost 30 years ago that […]
If you have a “Breakthrough” medical device, the FDA has a proposed expedited PMA proposal for you. But you’ll have to share more data sooner with senior FDA staff. Will this work? See what some experts told us.
All the major orthopedic companies have reported first quarter sales. How did the Big Six (soon to be Big Five) fare after a great fourth quarter of 2014? Bob Hopkins, senior analyst at Bank of America/Merrill Lynch did the numbers. But Hopkins cautions that he hesitates to read too much into quarterly market share assumptions […]
NuVasive Inc.’s first quarter sales rise of 11.3% made Wall Street happy and prompted Piper Jaffray analyst Matt Miksic to write that the results demonstrate the company’s aptitude for “sustainable execution and share gains.” It sounds like he was channeling company Chairman and CEO Alex Lukianov’s mantra of, “Onwards and Upwards.” Sales of $177.5 million […]
Physicians have a couple of new weapons when fighting insurance carriers who deny claims for payment—their patients and the Affordable Care Act. Data collected by Capital Public Radio in California found that about half the time a patient challenges a denied health care service through a third party, the patient wins. The Affordable Care Act […]
“Capture the Bundle, ” Richard Rothman, M.D., founder of the Rothman Institute and one of the most successful physician-owned and led academic orthopedic centers in the U.S., told attendees at the recent annual meeting of the American Academy of Orthopaedic Surgeons (AAOS). His colleagues appear to be listening. According to a KPMG LLP poll conducted […]
In the midst of Zimmer Holdings, Inc.’s announcement of buying up Biomet, Inc., the company also announced first quarter sales results on April 24, 2014 Net sales of $1.161 billion were up 2% on a reported basis over the previous year’s first quarter. Sales rose 3.2% on a constant currency basis. The company expects full-year […]
Stryker Corporation’s 2014 first quarter reconstructive sales rose 4.5% to $999 million. On a constant currency basis, sales rose 5.9%. Analysts called the quarter “sluggish” as the company’s sales came in slightly below expectation. During a conference call with analysts on April 23, 2014, company management cited the weather as a reason for the sluggish […]
Nine patients implanted with Stryker’s CerviCore implant say the metal-on-metal device poisoned them, that the company misled the public about failure rates and then illegally used OP-1 on them. Their lawsuit contains no “smoking gun, ” but they clearly want a chance to depose company executives. See what we found.
If we need more proof that the days of Marcus Welby, M.D. have passed, consider that 2013 was the year more patients chose specialists over primary care doctors. According to a report from the IMS Institute for Healthcare Informatics on how healthcare spending has risen after years of “self-rationing, ” all physician offices saw a […]
Aperion Biologics, Inc. has been granted CE Mark for the Z-Lig ACL Replacement Device. It is the first engineered biologic device for treatment of revision and multiligament anterior cruciate ligament (ACL) knee reconstruction to be granted a CE Mark or to be approved anywhere in the world. The approval for the off-the shelf biologic device […]
The podiatrist from Virginia who pled guilty in January to participating in a Medicare fraud scheme involving bone growth stimulators, is going to jail. Ilene Terrell, D.P.M., was sentenced to five months in prison, five months of home confinement and two years of supervised release on April 17, 2014. She was also ordered to pay […]
After receiving FDA premarket approval (PMA) in February for Monovisc, Anika Therapeutics, Inc. announced in mid-April the first commercial sale of the product by its commercial partner, DePuy Synthes Mitek Sports Medicine. Under a license agreement with Mitek, Anika is to receive a milestone payment of $5 million upon first commercial sale of the product […]
DePuy Synthes Companies orthopedic sales of $2.41 billion improved, on a reported basis, by 1.5% during the first quarter of 2014. On a constant currency basis, sales rose 2.7%. On a reported basis, trauma was the big performer, rising 6%. Knees were up 3%. Hips rose 1% and spine dropped 1%. Bumping Knees With Zimmer […]
In early March, Blue Cross and Blue Shield of North Carolina (BCBSNC) established a new bundled payment program for total knee replacement surgery through OrthoCarolina. Under the agreement with OrthoCarolina, BCBSNC customers will pay a single price for knee replacement surgeries and participate in OrthoCarolina’s coordinated care approach. Overall, participating BCBSNC customers are expected to […]
FzioMed, Inc. is going to get its day in the FDA’s “Court”—the Medical Device Dispute Resolution Panel (MDDRP)—on June 10, 2014. Medical Device Dispute Resolution Panel The MDDRP advises the Commissioner of the FDA on complex or contested scientific issues between the FDA and medical device sponsors, applicants, or manufacturers relating to specific products, marketing […]
DePuy Synthes Power Tools has a new electric drill for spine procedures. The Anspach EG1 High Speed Electric System has multiple attachments and accessories and, in addition to spine, is designed for neurosurgery and otology procedures. The system was launched at the 2014 American Association of Neurological Surgeons meeting in San Francisco in early April. […]
CMS just released the mother lode of payment and billing data to the public. Now lawyers, payers, bookkeepers and reporters can see what CMS claims surgeons did and how much they were paid. But watch out. Here are 15 essential facts every surgeon should know and prepare for.
On April 8, 2013 in an article titled, “Alphatec’s $49 Million French Adventure, ” we reported, “A jury found Alphatec Holdings, Inc., and its owners, HealthpointCapital, LLC, guilty of transferring assets for less than fair market value and millions would have to be paid to OrthoTec, LLC, the injured party.” We erred. None of those […]
Zimmer Spine, Inc. has launched a modular, stand-alone cervical device that, the company says offers secure fixation with no profile. The company is launching the Optio C Anterior Cervical System at the American Association for Neurological Surgeons (AANS) meeting being held April 5-9 in San Francisco. Steve Healy, the company’s president said, “With plate strength […]
A federal jury in California returned a $30 million verdict against NuVasive, Inc. on April 3, 2014 in a second trial in the company’s ongoing litigation with Neurovision Medical Products (Neurovision) over the right to use the trademark, “NeuroVision.” 2009 Lawsuit Neurovision sued NuVasive in September 2009 asserting claims of federal and state unfair competition, […]
Attaching tendons to bones is one of the most common needs in orthopedic surgery. Companies fight hard to protect their proprietary methods for accomplishing such fixation. Cayenne Medical, Inc. claims MedShape, Inc. has violated one of their soft tissue reconstruction patents. Infringement Alleged The company filed suit in federal court in Arizona, alleging that MedShape’s […]
The American Medical Association (AMA) CPT Editorial Panel has added a new Category I CPT code for two-level cervical total disc arthroplasty. The code will go into effect January 1, 2015. The Current Procedural Terminology (CPT) code set is a medical code set maintained by the AMA. The code set describes medical, surgical, and diagnostic […]
When Healthpoint Capital merged Alphatec and Scient’X in 2006, it stuck its finger into a festering litigation involving French spine companies, secret deals and a French doctor in Beverly Hills. When the dust settled, Alphatec agreed to pay $49 million to lance the boil. Is it over? Read here.
Biomet, Inc. just reported a great quarter and blew up Wall Street fears that orthopedic sales would begin to slow appreciably in the first quarter of 2014. Total reported quarter revenue of $822.5 million was up 6.6% over the previous year. On a constant currency basis, revenue climbed 7.5%. Losses Diminish Even better news […]
Providence Medical Technology, Inc. of Lafayette, California, just announced the closing of a $6.8 million Series C round of financing to advance the company’s cervical fusion technology. The new funding, according to Providence CEO, Jeff Smith, comes as the company is launching its DTRAX technology in the U.S. with over 15 independent distributors and over […]
The FDA says the number of recalled medical devices doubled from 604 in 2003 to 1, 190 in 2012. Class I recalls, the most serious, rose from 7 in 2003 to 57 during that period. While that overall 97% increase seems astronomical, Steve Silverman, director of the FDA medical device center’s office of compliance, told […]
Call it political Münchausen syndrome by proxy. Molly Cooke, M.D., FACP, president of the American College of Physicians (ACP) said Congress was holding healthcare for seniors, military families, and disabled persons on Medicare and TriCare “hostage.” For the seventeenth time in 11 years, Congress has acted at the last minute to save the patient made […]
Metal-on-metal hip implants do not raise the risk of developing cancer. At least if you live in Finland, according to a recent study published in the February 2014 edition of the medical journal, Acta Orthopaedica. A cohort of 10, 728 metal-on-metal hip replacement patients and a reference cohort of 18, 235 conventional total hip replacement […]
The 2014 AAOS Annual Meeting looked to the future. Healthcare reform anxiety is still around. But, says AAOS’s new leadership, great opportunities lie ahead in a time of disruption. In the exhibit hall, the ortho bazaar is back. And the smartest guys in the room are encouraging their colleagues to “Capture the Bundle.”
Orthofix International N.V. continues its transformation with the announcement on March 24, 2014, that Ron Matricaria is the company’s new chairman of the board.
Orthofix International N.V. announced on March 25, 2014 that net sales for 2011 and 2012 were $42.9 million less than previously reported. When Brad Mason took over at Orthofix in 2013, the company announced it was reviewing previous revenue reports and would be restating financials in SEC filings. The restatement of revenues was primarily due […]
The FDA has improved its performance in reviewing device applications since 2010. Margaret Hamburg, M.D., the agency’s commissioner, told Congress on March 13, 2014 that since that date, the agency has achieved: 27% decrease in the backlog of lower device applications 10% decrease in average total review time 43% decrease in higher risk devices backlog […]
Zimmer Holdings, Inc. orthopedic devices remain the implants of choice of the U.S. Department of Defense. On March 18, 2014, the Defense Department announced that the company has been awarded a $65 million modification exercising the third option period on a one-year base contract with the Defense Logistics Agency Troop Support located in Philadelphia, Pennsylvania. […]
No product has generated more questions about off-label use than Medtronic’s Infuse. From The Spine Journal to the U.S. Senate, partisan advocates have vilified Medtronic for their promotion of the product. Now the lawsuits have started and patients are claiming harm because Medtronic promoted off-label uses. Read what one patient has to say.
Congressional Republicans have thrown a huge monkey wrench into a previously bipartisan effort to fix CMS’ much maligned sustainable growth rate (SGR) formula. The bipartisan deal was agreed to in early February. “It’s a sad state of affairs, ” Thomas Barber, M.D., a lobbyist for the American Academy of Orthopaedic Surgeons, told Reuters. “To see […]
The Sunshine Act requiring device companies to publicly report payments to physicians kicks in this fall. Based on a recent Yale University study, physicians better pay attention to what companies are reporting in payments because they can expect to find some big discrepancies between what device manufacturers are reporting to the government and what they […]
The Kosciusko County Council voted unanimously on March 13, 2014 to move forward a request from Biomet, Inc.’s Global Vice President of Finance, Richard Fradette, to abate taxes on a potential expansion of the company’s headquarters in Warsaw, Indiana. The Journal Gazette of Fort Wayne, Indiana, reported on March 15, 2014 that company officials said […]
DePuy Synthes Companies announced two new improvements to the company’s Attune Knee System on March 12, 2014 at the annual American Academy of Orthopaedic Surgeons meeting in New Orleans, Louisiana. After introducing the Attune system a year ago and implanting more than 31, 000 of the devices during that time, the company added a rotating […]
There will be fewer toe fusions as Arthrosurface, Inc., founded in 2002, has received FDA clearance for its ToeMotion Total Toe Restoration System. The company announcement on March 7, 2014, said the device will be launched at the AAOS (American Academy of Orthopaedic Surgeons) in New Orleans the week of March 10th. The system consists […]
Knee sales rose almost 7% in the fourth quarter. Wall Street analysts wanted to know why and asked physicians–73% of surveyed docs said patient behavior changed during the quarter; 35% attributed the changes in behavior to the “Pull-Forward” theory resulting from concerns about Obamacare. The device chiefs also weighed in. Read it here.
Wright Medical Group, Inc.’s road for reaching FDA approval for its PMA (premarket application) for Augment Bone Graft has been rocky and highlighted by a contentious FDA orthopedic panel meeting in 2011. On August 8, 2013, the company received an 18-page “not approvable” letter from the FDA for the product. The FDA said it was […]
Bacterin International Holdings, Inc. has secured access to an additional $4 million loan from ROS Acquisition Offshore (ROS). The company entered into the loan agreement on March 6, 2014 and will pay an interest rate of LIBOR (London Interbank Offered Rates) plus 12.13%, subject to a LIBOR floor rate of 1%. Bacterin also agreed previously […]
Zimmer Holdings, Inc. says there is a “Trojan Horse” being built in Amarillo, Texas to sneak sales reps into the operating room to attack their business and steal their money and customers. Who, allegedly, are the Greeks in this Trojan War? Stryker Corporation.
It’s official. Biomet, Inc. is going public to reduce company debt. The company announced on March 7, 2014 that its parent company, LVB Acquisition, Inc., has filed a registration statement with the Securities and Exchange Commission (SEC) for a proposed initial public offering of its common stock. In connection with the offering, LVB Acquisition intends […]
Kelly Reisig was in Omaha, Nebraska in the ’80s when Arthur Steffee, M.D. came to perform spine surgery on her. She recently wrote OTW to say that 35 years after the successful surgery she is experiencing a “click” in her back and is having trouble finding a spine surgeon to monitor her. Here is what […]
Monovisc, a single injection supplement to synovial fluid of an osteoarthritic joint, and made by Anika Therapeutics, Inc., has received approval of its FDA premarket application (PMA). The company announcement on February 25, 2014, said the product will be marketed in the U.S. by DePuy Synthes, Mitek Sport Medicine, under a licensing agreement. Anika will […]
Zimmer Holdings, Inc. has five new patents for its Subchondroplasty Procedure. The U.S. Patent and Trademark Office issued the new patents for the new joint preservation procedure developed by Zimmer Knee Creations. The patents are numbers: 8, 551, 178, 8, 574, 303, 8, 608, 802, 8, 617, 166 and 8, 623, 089. A February 24, […]
So far, U.S. Supreme Court “Preemption” decisions have kept Medtronic, Inc. from having to go to a jury to defend itself in several Infuse lawsuits. But that may be about to change as a state judge in Minnesota has ruled that the company can be sued in state court on charges that it manipulated research […]
You gotta love insurance companies for their audacity. After years of earning profits by receiving a 12% premium to cover Medicare seniors through Medicare Advantage programs, the carriers are now getting pulled back to help cover the costs of insuring the noninsured through the Affordable Care Act (ACA). On Friday, February 21, 2014 the government […]
According to the Wall Street Journal, Biomet, Inc. is in talks with bankers about an initial public offering (IPO). The Journal reported on February 12, 2014 that the company is in discussion with banks about returning to public ownership after being taken private for $11.3 billion in 2007 by four Wall Street buyout firms. The […]
Re-injecting a patients’ own stem cells after culturing them is not “the practice of medicine, ” it is making and using a drug—says the appeals court which ruled against Chris Centeno, M.D., who’d challenged the FDA’s authority to regulate his “Regenexx” procedure. Read the civics lesson here.
Over the course of two days in February (18th and 19th), Stryker Corporation announced agreements to acquire Berchtold Holding, AG, and Pivot Medical, Inc. for the company’s MedSurg and Neurotechnology division. Berchtold, a privately held business in Germany and the U.S., sells surgical infrastructure equipment. The purchase price is $172 million. Pivot, is a Sunnyvale, […]
Medtronic, Inc.’s reported spine revenue was flat, on a constant currency basis, during the last quarter. Total spine sales were $744 million. Core spine was also flat. A company announcement on February 18, 2014, said that if declining balloon kyphoplasty sales were excluded, core spine sales grew in the low single-digits. BMB (Infuse) revenue declined […]
The Advanced Medical Technology Association (AdvaMed) says the 2.3% medical device excise tax implemented on January 1, 2013, has cost America as many as 165, 000 jobs. The association conducted an electronic survey of all its members between November 14 and December 9, 2013. Approximately 15% (38 companies) responded. Those companies, according to a February […]
Like the British navy sailing to the Falkland Islands, the Food and Drug Administration (FDA) has been signaling that big changes are afoot in 2014 in how the agency will be reorganized. In late 2013, the agency announced it would need to “realign” its programs to keep up with “unparalleled challenges” posed by advances in […]
Readers of Orthopedics This Week paid tribute to Antonio Castellvi, M.D. last week by registering the highest number of pageviews we’ve ever had for a story of a surgeon. Readers also paid tribute with their words. Below are some of the comments.
Chill out, dude, and don’t bleed until you’re shot! That’s in essence what a federal court in California told Reliance Medical Systems, LLC, on February 5, 2014, as it dismissed the company’s constitutional challenge to the U.S. Department of Health and Human Services’ Office of Inspector General’s (OIG) March 26, 2013 Special Fraud Alert (Alert) […]
Interventional Spine, Inc. now has FDA clearance for 11 additional sizes of its Opticage Expandable Interbody Fusion Device. The company announcement, on February 12, 2014, stated that the new sizes allow surgeons to match an Opticage to more than 80% of their patients requiring lumbar fusion surgery. The device features a continuously adjustable height within […]
Medicare saved more than $380 million in 2012 through Medicare Accountable Care Organization (ACO) initiatives, Pioneer ACOs, Physician Group Practice demonstrations, and expanded participation in the Bundled Payments for Care Improvement Initiative. The Centers for Medicare & Medicaid Services (CMS) announced the savings on January 30, 2014, in an interim financial report. On the same […]
“We regret to inform you that your PMA (premarket approval) application is denied.” With those words on October 21, 2013, the FDA notified John Krelle, the president and CEO of FzioMed, Inc. that his company’s Oxiplex Gel product will not be allowed in the U.S. The agency posted the letter on their website on February […]
A shift from traditional Corporate Integrity Agreements to “Probation Lite” may be the government’s next effort to curb corporate recidivism in the medical devices and pharmaceuticals industries. The nation’s top prosecutor made waves recently as he outlined a new strategy. We’ve got it here.
While hospitals expect to cut costs for orthopedic devices, they expect their earnings to grow in 2014. Hospital purchasing managers expect a slight improvement in procedure growth and mixed pricing trends in 2014. In addition hospital cost-reduction efforts will continue to be most focused on orthopedics. Those are the findings of a survey of 106 […]
A federal judge approved settlement of Biomet, Inc.’s metal-on-metal hip lawsuits on February 3, 2014. The company now joins Johnson & Johnson’s (J&J) DePuy Synthes Companies and Stryker Corporation in announcing some settlements of consolidated lawsuits. M2a Magnum System The cases in Biomet’s litigation primarily involved alleged defects in Biomet’s M2a Magnum system of hip […]
Amedica Corporation plans to raise $35 million in the company’s initial public offering (IPO). According to nasdaq.com, the announcement was made on January 29, 2014. The Salt Lake City, Utah-based maker of medical devices using its silicon nitride technology platform plans to offer 3.2 million shares at a price range of $10 to $12. At […]
Kevin Lobo took over Stryker Corporation at one of the most critical junctures in the history of medicine. He took over from a boss who expounded steady and consistent growth. Lobo, however, wants transformative changes. Can he recreate this venerable stalwart of the orthopedics industry? Read what he has to say.
The Justice Department’s Medicare Fraud Strike Force set a record for numbers of healthcare prosecutions in 2013. The strike force filed 137 cases, charged 345 individuals, secured 234 guilty pleas and succeeded in securing 46 jury trial convictions. The defendants charged and sentenced are facing an average of 52 months in prison. The strike force […]
Zimmer Holdings, Inc.’s 2013 fourth quarter sales of $1.24 billion were up 6.6%, excluding currency. David Dvorak, Zimmer’s president and CEO, said the strong results were led by the successful commercialization of the Persona Personalized Knee System and its accompanying suite of next-generation instruments. Indeed, excluding a 2% currency hit, knees were up a whoppin’ […]
The Kiva VCF Treatment System is for the reduction and treatment of VCFs (vertebral compression fractures) of the spine. According to the company announcement on January 28, 2014, the clearance makes the Kiva the first new approach to the treatment of VCFs in over a decade. Also, according to the company, in the clinical studies […]
ZipLine Medical, Inc. has raised $4.3 million in a Series C financing round. The company, founded in 2009 and headquartered in Campbell, California, made the announcement on January 21, 2014. Skin closure is the common denominator of nearly all surgical procedures. With that in mind, Amir Belson, M.D. started the company to develop a noninvasive […]
Pricing contracts between device manufacturers and their hospital customers aren’t the only transactions in healthcare where pricing transparency is lacking. It’s also hard to get financial information when large health systems attempt to acquire physician practices. According to healthjournalims.org, news organizations in Idaho are asking a federal appeals court in San Francisco to unseal pricing […]
John Kostuik, M.D.’s baby is 10 years old and has grown up to become the largest private spinal implant company in the world. K2M Group Holdings, Inc. (K2M) turned 10 years old on January 24, 2014. Before co-founding K2M, Dr. Kostuik was the chief of spine surgery at The Johns Hopkins University School of Medicine. […]
The U.S. healthcare industry reported its first monthly loss of jobs in 10 years. Politicians and economists were quick to place blame and credit. According to a January 10, 2014 Bureau of Labor Statistics (BLS) report, 6, 000 jobs were lost in December 2013 in the sector. Overall the U.S. added 74, 000 jobs during […]
Good news in knees, continued Synthes integration challenges in spine and an improving orthopedic market dominated Johnson & Johnson Alex Gorsky’s fourth quarter conference call with analysts on January 21, 2014. J&J’s DePuySynthes orthopedic unit reported a 4.2% rise in revenue for the fourth quarter of 2013, excluding currency. The company said strong growth for […]
Seven months ago, a Virginia podiatrist named Ilene Terrell, D.P.M., was indicted for manipulating patient medical records and then lying about it to a grand jury. The indictment also claims Terrell lied to Orthofix, Inc. auditors. On January 15, 2014, Terrell was convicted. Terrell pleaded guilty to four counts of making a false declaration to […]
Percutaneous image guided lumbar decompression (PILD) for lumbar spinal stenosis (LSS) will now be paid for by the Centers for Medicare and Medicaid Services (CMS) for patients enrolled in an approved CED (Coverage with Evidence Development) clinical study. That’s great news for patients and companies like VertiFlex, Inc. and Vertos Medical Inc. Treating Spinal Stenosis […]
First lawmakers came after physician owned hospitals and distributors. Will they come after surgical centers next? Some lawyers say yes. One gives some great advice on keeping your ASC safe in 2014. Read on.
The Food and Drug Administration (FDA) is getting back the $85 million industry-paid user fees that fell victim to sequestration in 2013. The agency is also getting a hefty 8% raise with an additional $91 million above 2013 funding levels from Congress in the recently passed $1.1 trillion spending bill. The passage of the new […]
The Centers for Medicare and Medicaid Services (CMS) announced on January 14, 2014, that the agency is going to start disclosing by March 17, 2014 how much money individual physicians earn treating Medicare patients. The information is not going to be disclosed in a massive report, but will be released in response to Freedom of […]
The FDA has cleared K2M, Inc.’s Cayman Minimally Invasive, (Cayman MI) the company’s latest addition to its Cayman product line of plate system. The 510(k) clearance was announced in a January 8, 2013 press release from the company. Eric Major, K2M’s president and CEO, said the expansion of the plate systems not only enhances the […]
Kevin Stone M.D. responded to a request from OTW to comment on the recent sham knee surgery study out of Finland. Here is what he had to say: “A recent comparative study compared sham knee surgery to a partial resection of the meniscus in 45- to 60-year-old people and noted no difference at one year. […]
ArthroCare Corporation’s long DiscoCare nightmare under a previous management team appears to be coming to an end. On January 7, 2014, the company announced a Deferred Prosecution Agreement (DPA) with the U.S. Department of Justice (DOJ). The DPA will resolve the ongoing investigation by the DOJ regarding allegations of securities and related fraud over false […]
George Dunbar, Jr. is taking over as CEO and president of ISTO Technologies, Inc. Dunbar has over 25 years of experience in the field of life science tools, diagnostics and medical devices as an investment banker, president, CEO and board chairman.
The momentum to replace the SGR and repeal the device tax has never been stronger. Lawmakers from both sides have voted over and over for replace and repeal. A new budget delays physician cuts and gives lip service to dumping the tax. Will this year be different? The political calendar and climate say don’t bet on it.
DePuy Synthes Spine and DePuy Synthes Biomaterials have collaborated to produce a hydrated, pliable and totally demineralized cancellous bone matrix that fills voids during posterolateral spine fusion surgery. Furthermore, the company says the matrix provides a natural scaffold for new bone formation. The U.S. launch of Conform Sheet was announced on January 6, 2014 and, […]
Biomet, Inc. reported terrific knee sales for the most recent quarter. Reported sales grew by 6.6%, causing Wall Street analysts to predict equally promising results for Biomet’s competitors. Overall reported sales for the companies 2014 second quarter were up 4.5% to $826 million. Reported hip sales rose 2.3%, extremities and trauma climbed 5.3%, spine and […]
Soft Tissue Regeneration, Inc., (STR) has added money and expertise to its efforts to offer ACL (anterior cruciate ligament) patients an alternative to autograft or allograft therapies. On January 6, 2013, the company announced the completion of a $5 million financing effort and the addition of Biomet, Inc. founder, Dane Miller, Ph.D. to the company’s […]
It wasn’t even close. The dangerous Mr. Kaul is no longer a licensed physician in either the United States or the United Kingdom and the judge who presided over his three-month circus of a trial threw the book at him. What’s next for whom some call one of spine’s most notorious rogues? The answer, which is not jail time apparently, is still shocking. Read on.
Johnson & Johnson’s DePuy division wasn’t the only device company settling metal-on-metal hip lawsuits at the end of 2013. According to the New Jersey Record, four patients settled their claims against Stryker Corporation in New Jersey at the beginning of December. The patients alleged that the company’s Rejuvenate metal-on-metal hip injured them. Attorneys representing the […]
Memphis-based Solana Surgical, LLC has been cleared by the FDA to market its CrossCheck plating system used by orthopedic and podiatric surgeons in foot and ankle procedures. The company expects to begin commercializing the product in the first quarter of 2014. According to a December 20, 2013 company announcement, the first phase of commercialization will […]
The year 2013 was another banner year for healthcare whistleblowers. The year also included the largest judgment in the history of the Stark Law with Tuomey Healthcare System, Inc. ordered to cough up $237 million. According to the Department of Justice (DOJ), the government paid out more than $345 million to “courageous” individuals who exposed […]
Stryker Corporation’s Tim Scannell’s New Year’s Eve resolution is to stop leaving sponges in patients after surgery. So his division is paying $120 million for a system used at grocery checkout counters and intended to prevent objects being left in patients after surgery. The company announced it was acquiring Patient Safety Technologies, Inc. (PST) for […]
Sham surgery is just as effective as an arthroscopic partial meniscectomy in diminishing knee pain. That’s the result of a trial from the University of Helsinki, Finland involving 146 patients reported in the December 16, 2013 issue of the New England Journal of Medicine (NEJM). None of the patients had knee osteoarthritis but had symptoms […]
One of the world’s largest drug makers is going cold turkey and cutting off payments to physicians for hawking their drugs. GlaxoSmithKline (GSK), Britain’s biggest pharmaceutical company announced on December 17, 2013, that it will stop paying physicians for promoting its drugs and scrap prescription targets for its marketing staff. The entire industry has been […]
DePuy Synthes Trauma is launching a new radial head prosthesis system just in time for Northerners who break their smaller bone (radius) in the forearm while cushioning their fall on the ice. The most common cause of a radial head fracture is breaking a fall with an outstretched arm. The radius bone goes from your […]
A federal budget bill including a 3-month SGR (sustainable growth rate) “patch” and a non-binding repeal of the 2.3% medical device tax was passed by the U.S. Senate on December 18, 2013. The House of Representatives passed the bill a few days earlier. When the bill gets to the President, he has reportedly agreed to […]
NuVasive, Inc. has launched its ALIF ACR in the U.S. The Anterior Lumbar Interbody Fusion -Anterior Column Realignment (ALIF ACR) focuses on correcting the sagittal plane imbalance that results from advanced degeneration. The December 17, 2013 company announcement stated that the product offers surgeons a “familiar ALIF technique to increase alignment where 80% of sagittal […]
Medicare is going to inflict some real pain on knee and hip surgeons in 2014 by lowering payments by 10% and 4%. The agency says reimbursements for those procedures have been “misvalued.” With sequestration and a 24% SGR cut scheduled in January, are surgeons finally going to stop fixing grandma and grandpa’s hips and knees?
“Where’s Dr. Durrani?” Atiq Durrani, M.D., a Pakistani-born spine surgeon who is under investigation for allegedly billing Medicare for three times as many lumbar spine fusions as anyone in Ohio over three years, has disappeared. According to WXIX-Fox19 News, the Cincinnati area surgeon was arrested in July for allegedly performing unnecessary surgeries and violating federal […]
Lawyers from the law firm of Hogan Lovells take off the gloves and pound on Dr. John Steinmann’s “spin” of the OIG Special Fraud Alert regarding physician-owned distributors. They argue the Alert destroys the credibility of any justification of the POD business model of reducing costs. Get your front row seat.
Baxano Surgical, Inc. is ending the year on reimbursement and clinical high notes. On December 6, 2013, the company announced the publication of two clinical studies on the AxiaLIF Plus presacral access and interbody fusion system and the iO-Flex minimally invasive decompression instrument. Both studies are featured in the December 1 edition of the Journal […]
After seven years of clinical and radiographic outcomes under their belts, patients with Medtronic, Inc.’s Prestige Cervical Disc kept their improvements and had significantly lower rates of additional surgery when compared to anterior cervical discectomy fusion (ACDF). Vincent Traynelis, M.D., director Neurosurgery Spine Service, and vice chairperson and professor, Department of Neurosurgery, at Rush University […]
Christopher Ridgeway, the fired Stryker Corporation sales rep we’ve written about who accused the company of making up a fake non-compete agreement, is suing his former employer for unfair trade practices, fraud, unjust enrichment and intentional interference with his business relations. Ridgeway is the owner of Stone Surgical, LLC, which he runs out of his […]
If you are a surgeon who works for a hospital, your pay depends on your employer maximizing all the reimbursements they can get from public and private sources. What if you found out that your hospital administrator was turning down federal reimbursement funds to pay for poor patients who show up at your doorstep? Worse […]
How much starch do you want on that graft? That’s a question an orthopedic surgeon might ask in the future because Soft Tissue Regeneration, Inc. (STR), the New Haven, Connecticut-based clinical stage company working on soft tissue regeneration devices using corn starch, has almost reached it’s $5 million funding round goal. So far, according to […]
Stephen MacMillan is returning to the medical device industry as president and CEO of Hologic, Inc.
The FDA has zipped Aurora Spine Corporation’s interspinous fusion system through the 510(k) clearance process. The company announced on December 3, 2013, that the agency granted clearance for the ZIP Minimally Invasive Interspinous Fusion System. The system was developed as an alternative to pedicle screw systems. The system has been launched in Europe and already […]
Amedica Corporation is teaming up with the world’s big dog of advanced ceramics. On November 26, 2013, the company announced a deal with Kyocera Industrial Ceramics Corporation whereby Kyocera will use Amedica’s Silicon Nitride biomaterial to manufacture medical devices in Vancouver, Washington. Eric Olson, Amedica’s president and CEO, said there is an unmet need for […]
Want to earn a bonus and avoid paying a penalty in 2015 under the Physician Quality Reporting System (PQRS)? Then follow these simple government instructions. If you are paid under the Medicare Physician Fee Schedule (PFS), you will be subject to payment penalties beginning in 2015. The providers and group practices that do not satisfactorily […]
If you fail to disclose that you don’t have medical malpractice insurance before you perform surgery on a patient and something goes wrong, is that fraud? According to Law360, a New Jersey couple named James and Sheila Jarrell were awarded less than $938, 000 by a jury after the jury found their spine surgeon had […]
Will physicians accept a 30% cut to treat patients enrolled through state health exchanges? About 20 million new patients are expected to be enrolled via exchanges by 2016. But most physicians aren’t aware of the coming changes. Maybe they need to buy a clue.
Lawyers representing over 8, 000 plaintiffs in DePuy ASR hip lawsuits are recommending that their clients accept Johnson & Johnson’s (J&J) $2.5 billion settlement offer. For good reason. According to a November 25, 2013 New York Times article by Barry Meier, the lawyers stand to earn almost $1 billion. Those lawyers have publicly praised the […]
The United Kingdom has banned metal-on-metal hips. The UK’s National Health Service (NHS), following new guidelines issued by the country’s National Institute for Health and Care Excellence (NICE) has banned most metal-on-metal hip implants in all hospitals funded by NHS. Few of the implants would meet the new standards set by NICE. The ban will […]
Physician-owned hospitals that want to keep their “whole hospital” or “rural providers” exceptions to the Federal Stark Law have until December 1, 2013 to report their ownership and investment information to the Centers for Medicare & Medicaid Services (CMS). The hospitals, according to lawyers from Bradley Arant Boult Cummings LLP, should carefully review their Medicare […]
Allegations that a couple of medical professors and FDA advisors shook down drug companies for hundreds of thousands of dollars to “impact” FDA thinking, has a U.S. Senator calling for an investigation. Is the FDA about to be embroiled in a “Pay for Play” Scandal? See what we found.
Our friends at Retraction Watch (RW) reported on November 11, 2013, that a third orthopedic medical journal has retracted a paper submitted by San Diego-based orthopedic surgeon, Harish Hosalkar, M.D.
The second year of Medicare’s Hospital Value-Based Purchasing Program (HVBP) will not be kind to nearly 1, 500 hospitals that will be hit with negative reimbursement adjustments. Not surprisingly, physician-owned hospitals again fared the best. Hospitals are judged on a variety of criteria, including comparative scoring, patient surveys, and a series of quality measures judging […]
It’s official. DePuy Orthopaedics, Inc. announced on November 19, 2013, that the company and a court-appointed committee of lawyers representing ASR hip plaintiffs have reached a $2.5 billion deal to compensate patients with failed hip revision surgeries. According to Bloomberg, Susan Sharko, one of the company’s lawyers, told U.S. District Judge David Katz in Toledo, […]
It was, in the words of Medtronic, Inc. CEO, Omar Ishrak, a challenging quarter for Medtronic Spine. Revenue of $746 million declined 3% on a constant currency basis or 5% as reported. Core Spine revenue of $636 million was down 1% while BMP revenue of $110 million declined 17%. There was some good news. The […]
Silicon nitride orthopedic and spine device maker Amedica Corporation is hoping to raise $35 million in an initial public offering (IPO). The Salt Lake City, Utah-based company filed papers with the U.S. Securities and Exchange Commission (SEC) on November 8, 2013 to raise the funds. The company had initially filed the SEC documents confidentially in […]
The AMA’s secret payment advisory committee (RUC) has made recommendations to Medicare that could cut payments to hip and knee surgeons. Industry, Wall Street and clinicians are raising the alarm bells. What will it mean? Biomet’s CEO Jeff Binder predicts less access to surgery. Wall Street’s Raj Denhoy isn’t so sure. Here are the details.
After Stryker Corporation acquired Orthovita, Inc. in 2011, the feds charged former Stryker marketing executive Mark Foldy with insider trading. On October 7, 2013, Foldy, along with Mark Cupo, John Lazorchak and Michael Pendolino plead guilty to the charges. On November 13, 2013, two brokers, Lawrence Grum and Michael Castelli each admitted to two counts […]
Bloomberg reported on November 12, 2013 that Johnson & Johnson (J&J) has agreed to pay more than $4 billion to settle thousands of ASR (Articular Surface Replacement) metal-on-metal hip lawsuits. That comes to about $350, 000 per case. Previous settlement rumors were in the $2 billion range. The company settled a $2.2 billion case with […]
Titan Spine, LLC’s Endoskeleton interbody fusion devices with their unique roughened surface technology have now been implanted 18, 000 times and are approaching a $20 million in annualized sales revenue run-rate. A company announcement on November 11, 2013 stated the two achievements mark a, “paradigm shift toward devices engineered with roughened titanium surface technology.” Roughened […]
The FDA’s orthopedic expert panel will meet on December 12, 2013 to make recommendation regarding the classification of spinal sphere devices. The devices are currently regulated under the heading of “Intervertebral Fusion Device with Bone Graft, Solid-Sphere, Lumbar”, Product Code NVR, as unclassified devices and reviewed under the 510(k) premarket notification authority. FDA is seeking […]
Just when you think it’s not safe to wade into FDA waters, the agency throws someone a lifeline. FzioMed, Inc. boss John Krelle announced on November 4, 2013, that FDA Commissioner Margaret Hamburg, M.D. has approved the company’s petition for an independent review of its premarket approval application (PMA) for Oxiplex Gel. The agency issued […]
An independent evaluation comparing Benvenue Medical, Inc.’s Kiva VCF (vertebral compression fracture) system to balloon kyphoplasty found that Kiva delivered “significant improvements in back pain.” The Pain Physician Journal, the official publication of the American Society of Interventional Pain Physicians, published the results of the peer-reviewed study in the September/October edition of the journal. The […]
Globus Medical, Inc. added to the positive spine news for the third quarter by reporting $107.2 million in sales, up a whoppin’ 13.1% over the previous year. Analyst Bob Hopkins of Bank of America called it a “robust quarter.” The company beat consensus by $1 million. U.S. sales growth was 13%, while outside the U.S. […]
Johnson & Johnson (J&J) has $2.2 billion less to spend on settling metal-on-metal hip lawsuits because the company just agreed to pay the U.S. Justice Department that amount to resolve criminal and civil allegations of promoting prescription drugs not approved by the FDA. The allegations against the company and its subsidiaries, Janssen Pharmaceuticals, Inc. and […]
Christopher Ridgeway was one Stryker’s top salesman. When Stryker fired him he went to work for Biomet. Stryker sued them both, saying Ridgeway violated a non-compete agreement. Then Biomet fired Ridgeway. Ridgeway says Stryker fabricated the non-compete agreement, that there never was an NCA. Here’s the rest of this crazy story.
NuVasive, Inc., built for speed and growth, continued with double-digit revenue growth in the third quarter. The 14% growth over last year’s third quarter to $169.2 million wasn’t the heady 20%+ growth rate of years past, but still way over the market which is only growing in the lower single digits. “NUVA put up a […]
The Securities and Exchange Commission (SEC) charged Stryker Corporation with making illicit payments of $2.2 million to healthcare providers in Argentina, Greece, Mexico, Poland, and Romania in violation of the Foreign Corrupt Practices Act. On October 24, 2013, the government announced that Stryker agreed to pay more than $13.2 million to settle the charges. The […]
Stryker Corporation says Biomet and a former Stryker sales rep concocted a recipe to flip business and poach sales reps from Stryker to Biomet in New Orleans. The rep, Christopher Ridgeway, accuses Stryker of fabricating a bogus non-compete agreement. It’s a rolling boil of a stew in the Big Easy. This week we bring you Stryker’s version.
The government’s stand that PODs are inherently suspect is a violation of the First Amendment. That’s the position of two former sales reps, now owners of Reliance Medical. They claim “Big Corporations” got the OIG to go on a “crusade” against physician-owned businesses because of their success in the marketplace. Not all PODs are on board.
Zimmer Holdings, Inc.’s third quarter reconstructive sales rose 4% on a reported basis to $788.3 million. Excluding currency, sales climbed 6%. Overall, said BMO Capital Markets analyst Joanne Wuensch, the company’s total revenue increased at the highest rate since the fourth quarter of 2007. Excluding currency, knees were up 7%, hips up 2%, extremities up […]
PODs do not supply devices at a lower cost than other suppliers and may increase the cost of spinal surgery to Medicare over time. That’s the conclusion drawn by the long overdue report of the Office of Inspector General (OIG) requested by Congress last year on physician-owned distributorships. The OIG concluded in the 31-page report […]
The Brits, who first raised warnings about metal-on-metal hips, have issued a new draft guidance with stricter benchmarks for quality. The National Institute for Health and Care Excellence (NICE) issued the draft guidance on October 18, 2013. The guidance recommends that a new hip should work well in at least 95% of cases over 10 […]
Medtronic, Inc. says it has scored a first by introducing the first procedure that allows lateral access to the most common operative level of the spine. According to an October 21, 2013, announcement, the OLIF51 procedure enables reproducible lateral access to the L5-S1 disc space. “For the first time, along with the OLIF25 Procedure, the […]
Stryker Corporation’s reconstructive net sales popped 6.5% (on a reported basis), to $949 million during the third quarter of 2013. Hip sales rose 5.5%, knees were flat, trauma was up 18.1% and even spine was up 4.1%. “We are pleased, ” said Kevin Lobo, the company’s president and CEO. The company also jumped feet first […]
Globus Medical, Inc. received a Warning Letter on September 27, 2013, from the FDA over its MicroFuse Putty. According to an October 15, 2013 Globus SEC filing, the warning came after an inspection at the company’s Audubon, Pennsylvania, facility that occurred from May 7, 2013 until June 4, 2013. The company said the FDA cited […]
Johnson & Johnson’s DePuySynthes reported sales were down .3% to $2, 283 million for the third quarter of 2013. Currency took a 1.4% bite. Excluding currency, sales rose 1.1%. Pharma overtook devices during the quarter as the company’s largest business, prompting Bank of America analyst Bob Hopkins to call Johnson & Johnson (J&J) a “one-legged […]
Blue Belt Technologies, Inc. has made its first sale to an ambulatory surgical center and reported the first use of the company’s unicondylar knee system. The company announced on October 15, 2013 that the Thomas Jefferson Riverview Surgical Center, at the Navy Yard in Philadelphia, Pennsylvania, entered into an agreement to purchase Blue Belt’s Navio […]
The Society of Advanced Spinal Intervention (SASI) is holding its first meeting in Memphis, Tennessee, on Saturday, November 16, 2013. Turf War In the scope of practice turf war between interventional pain physicians and board certified orthopedic and spine surgeons, the interventionalists have been treated as a step-child by established surgical societies. So they are […]
DePuy Orthopaedics, Inc. has confirmed to OTW that a notice of settlement has been filed in the Robert Ottman ASR metal-on-metal case that was scheduled to go to trial October 15, 2013, in the Superior Court of California, County of San Francisco. The amount of the settlement was not disclosed. A company spokesperson told us […]
Biomet, Inc. reported making a profit in the last quarter and doubled down on the spine business. The day after announcing the $147 million acquisition of Lanx, Inc., the company reported a 3.3% increase in 2014 first quarter revenue to $730.7 million. Excluding currency, net sales increased 4.3%. Net income was $31.1 million versus a […]
ISTO Technologies, Inc., one of the companies in search of the Holy Grail of orthopedics—cartilage regeneration—has completed enrollment of its Phase 2 NuQu clinical trial. The trial is evaluating the efficacy and safety of NuQu, a cell-based therapy for the treatment of degenerative spinal discs. “Promising and Transformational” Domagoj Coric, M.D., of Carolina Neurosurgery and […]
If you testify against a colleague in court as an expert witness and you end up on the losing side, you may face an AAOS disciplinary hearing. This past summer the Academy Board took disciplinary action against four members. Read what it takes to get suspended and booted from the Academy.
MAKO Surgical Corp. is buying Pipeline Biomedical Holdings, Inc., before being acquired by Stryker Corporation. Pipeline has been MAKO’s partner since 2010. The company has developed and supplied advanced implant technologies for use with MAKO’s RIO Robotic-Arm Interactive Orthopedic system, including the proprietary MAKO-branded RESTORIS PST Cup and Tapered Stem hip implant system for use […]
Stryker Corporation Chairman Emeritus John Brown has received the first-ever AdvaMed Lifetime Achievement Award.
“Due to a lapse in funding, the U.S. federal government has shut down.” That’s the message people get when trying to get updated information from the FDA and the Department of Health and Human Services (HHS). While Medicare will continue to pay hospitals and physicians, device manufacturers and patients relying on new devices and therapies […]
Baxano Surgical, Inc. launched a disposable facetectomy instrument called the iO-Tome on October 1, 2013. The instrument, according to the company, allows surgeons to perform “rapid and safe” facetectomies when performing certain interbody spinal fusion procedures. Utilizing Baxano’s iO-Flex technology, the instrument delivers a new MicroBlade Shaver design configured to rapidly and precisely remove the […]
The biggest trial of the decade in orthopedics has been delayed again. On September 20, 2013, U.S. District Judge David A. Katz, who is presiding over the DePuy ASR hip implant multidistrict litigation issued an order postponing the start date of the bellwether McCracken trial from September 24, 2013, to sometime within the next 90 […]
What does the government shutdown mean for the orthopedic community? Not much for now. The shutdown won’t impact Medicare, Medicaid, Social Security or any of the essential government services required to protect the borders, public health and other mandatory functions, including Obamacare. During the 1995–1996 government shutdown, Medicare continued to pay physicians and hospitals according […]
Hip and knee implants are getting cheaper. That’s the finding of a new AdvaMed report. One data guru says that’s true, but the data was “tortured” and overstates its case. The numbers tell the story. Read the details here.
AdvaMed, the medical device industry’s trade association, has announced a new ad campaign to push Congress to repeal the device tax. This past week, the organization also released a study showing that the price of hip and knee implants has fallen since 2007 because of pricing pressures from hospitals. “This is the way of the […]
Say goodnight MAUDE. The November Research Group (NGR) announced on September 17, 2013 that it had won an FDA contract to have its Pharmacovigilance Report Intake and Managed Output (PRIMO) software system eventually replace the FDA’s Manufacturer and User Facility Device Experiences (MAUDE) system. MAUDE is the primary tool used by the FDA to receive […]
Stryker Corporation President and CEO Kevin Lobo continues to make bold moves to put his mark on Stryker Corporation. On September 25, 2013, he announced that Stryker was acquiring MAKO Surgical Corp. for about $1.65 billion. The price of $30 per share is an 86% premium to MAKO’s closing price on September 24, 2013 and, […]
Four major systems run by surgeons have formed the first ortho/spine physician hospital organization (PHO) to catch the wave of value-based reimbursement. They promise employers a one-stop-shop for their employees. Read about PHOs and learn about these ortho leaders.
The American Medical Association/Specialty Society Relative Value Scale Update Committee’s (RUC) meets behind closed doors and has a monopoly on making recommendations to Medicare for physician payments. A new bill in Congress would require Medicare to have their own expert panel to oversee the valuation of physician services and correct distortions in the fee schedule. […]
The FDA announced a final rule for the unique device identification system (UDI) on September 20, 2013. “UDI represents a landmark step in improving patient safety, modernizing our postmarket surveillance system for medical devices, and facilitating medical device innovation, ” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. […]
The FDA announced a final rule for the unique device identification system (UDI) on September 20, 2013. “UDI represents a landmark step in improving patient safety, modernizing our postmarket surveillance system for medical devices, and facilitating medical device innovation, ” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. […]
A novel bone cement delivery technology which does not require an implanted device in the spine has received FDA clearance. Crosstrees Medical, Inc. announced on September 19, 2013 that its PVA (percutaneous vertebral augmentation) Pod System was cleared after a prospective, single-arm IDE (investigational device exemption) study with 135 patients in the U.S., China, Venezuela […]
The FDA “cleared” 284 devices in August 2013 through the 510(k) program. Of those, 45 were orthopedic or spine related. During the same August period in 2010, 2011 and 2012, the agency cleared 241, 271 and 257 devices, respectively. Clearances are for products that have shown to be “Substantially Equivalent” to previously approved products. The […]
Trinity Orthopedics LLC, based in San Diego, California, has acquired Expanding Concepts LLC’s patent portfolio. In a September 16, 2013 press release, Trinity CEO James Marino, M.D., said acquiring the Expanding Concepts patents is an essential step in completing the development of an expandable interbody technology offering. In addition to founding Trinity in 2004, Marino […]
Morristown, New Jersey-based Tyber Medical, LLC has been granted CE Mark for its TyPEEK, proprietary titanium plasma sprayed PEEK interbody system. According to the company’s September 10, 2013 announcement, the interbody fusion device is designed to offer the benefits of bone growth with titanium along with the modulus and the post-op imaging characteristic of PEEK […]
After being fired, sued by former patients, investigated by the feds and nationally profiled, orthopedic surgeon Spyros N. Panos, M.D. decided to surrender his medical license. Some patients accuse him of faking surgeries. He has not been charged with any crime, but he has paid a price. Read what’s happening in Poughkeepsie.
On Friday, September 6, 2013, FDA Commissioner Margaret Hamburg, M.D., announced in an internal email that she was forming a “Program Alignment Group” charged with identifying and developing plans to modify FDA’s functions, processes, and possibly its structure in order to best achieve mission-critical Agency objectives.” “Significant strides in scientific innovation and increased biomedical discovery, […]
Over 350, 000 people suffer rib fractures every year in the U.S. DePuy Synthes CMF has launched new instrumentation that enables less invasive surgical fixation and stabilization of those rib fractures. According to a September 12, 2013 announcement, the MatrixRIB system is precontoured with low-profile titanium plates, locking screws and intramedullary splints. The company says […]
By only providing the tools needed, the FlowerCube will challenge the orthopedic status quo and cut implant and instrument costs by as much as 30%. That’s the promise Oliver Burckhardt made as he came roaring back into orthopedics with a September 4, 2013 announcement that his new company, Flower Orthopedics Corporation, had just made a […]
Active Implants LLC has closed the first tranche of $8.7 million in new funding for its knee repair technology. A total of $26 million has been committed by View Capital RIA, L.P. in Dallas, Texas and River Street Management in Memphis, Tennessee. The proceeds will be used to fund a multi-center trial on the company’s […]
The first federal DePuy ASR metal-on-metal hip trial that was supposed to start on September 9, 2013, has been postponed to September 24, 2013. The case is Ann McCracken vs. DePuy Orthopaedics, Inc., et al. On September 6, U.S. Federal District Judge David Katz ordered the postponement after conferring with the parties. He determined that […]
A Florida judge has ruled that Medicare may disclose its payments to individual physicians. Since the Carter Administration, CMS was prevented by privacy laws from disclosing payments to specific physicians. No more. CMS has to figure out if and how it discloses this sensitive data. Physicians are divided. Here’s what we found.
On September 4, 2013, Biomet Orthopedics, LLC, announced the first clinical use in the U.S. of the company’s Signature™ Patient-Specific glenoid instrumentation. The company says this is the only device of its type that features a patent-pending dual trajectory, allowing surgeons to elect a reverse or total shoulder procedure intraoperatively. The instrument’s glenoid guides utilize […]
The FDA has a new sheriff in charge of regulatory compliance and enforcement. FDA announced to FDA staffers that Melinda Plaisier would become the agency’s new permanent Associate Commissioner for Regulatory Affairs (ACRA). She had been the acting commissioner since last October.
The FDA has given SpineGuard S.A. clearance to market three new spine products in the U.S. The company announced the clearances on August 28, 2013. The products complete the company’s PediGuard platform of single-use drilling instruments, which secure the pedicle screw pilot hole. The products are two miniaturized versions of the company’s classic and curved […]
Biomet Inc. has to pay Neil Kahanovitz, M.D., a former president of the North American Spine Society $2.7 million in past-due royalties. Kahanovitz sued Electro-Biology Inc. and EBI LLC, two Biomet subsidiaries in 2011, after the companies stopped paying him $250, 000 in royalties from an agreement signed in 1992. He eventually stopped providing consulting […]
Jesse Wu, the company’s worldwide chairman of consumer business, will fill the newly created role of chairman of J&J China.
The FDA recently issued a 54-page draft guidance to help device manufacturers figure out if an event is adverse and reportable. The draft addresses specific questions about reporting and record-keeping requirements for device-related adverse events. You’ve got until October 7, 2013 to respond. Adverse Event According to the FDA, reportable events for manufacturers “are events […]
Stryker Spine has issued a Class I Recall of its OASYS Midline Occiput Plate. The recall follows a July Hazard Alert for the device from Australia’s regulatory agency, the Therapeutic Goods Administration. On August 29, 2013, the FDA posted the recall on its Medical Device website. According to the FDA, the recall was initiated May […]
Just three weeks after announcing FDA approval for one-level use of LDR Holding Corporation’s Mobi-C cervical disc, the company announced on August 28, 2013 that the agency has also granted approval for two-level cervical indications. The approval makes the Mobi-C the first and only cervical disc in the U.S. approved to treat more than one […]
The FDA has given Zimmer Holdings, Inc. permission to market the company’s Patient Specific Instruments (PSI) Shoulder System for reverse shoulder arthroplasty procedures (RSA). The system enables surgeons to plan the implant size and position, as well as bone preparation, including positioning the screw. It does this by utilizing 3D visualization software. European patients and […]
China’s regulatory oversight of business and health care is changing rapidly. New leaders have promised public examples of cleaning up corruption. Get ready to meet Xu Xinyu, a top regulator who will ask you to confess in return for leniency. Read what we learned about the new climate and laws.
Wound care products are regulated by the Food and Drug Administration (FDA) as a device. Effective immediately, certain products containing live cells will be regulated as a biologic product. The FDA announced on August 14, 2013 that the agency is transferring oversight responsibilities for certain wound care products containing live cells from the Center for […]
Wound care products are regulated by the Food and Drug Administration (FDA) as a device. Effective immediately, certain products containing live cells will be regulated as a biologic product. The FDA announced on August 14, 2013 that the agency is transferring oversight responsibilities for certain wound care products containing live cells from the Center for […]
Johnson & Johnson (J&J) is rumored to be considering a $3 billion settlement over the 11, 000 or so DePuy ASR hip implant lawsuits. In January, Bloomberg reported that five people familiar with the talks had said J&J officials were willing to pay about $2 billion to resolve the cases. Lawyers for plaintiffs rejected that […]
Medtronic, Inc.’s spine business reported $765 million in revenue for the company’s first fiscal quarter of 2014. Revenue declined by 1% on a constant currency basis over the same quarter the previous year. Core spine sales rose 1%, while biologics declined 11% on a constant currency basis. Core Spine Growing In a prepared statement on […]
The Chinese government is looking at the overuse of medical devices in Beijing after determining that overutilization is taking place to increase profits. John Tan, a lawyer with Reed Smith’s Global Regulatory Enforcement Group based in Shanghai, wrote on August 15, 2013 that the local Beijing office of the Ministry of Health (MOH) of the […]
Stryker Australia and Australia’s regulatory agency, the Therapeutic Goods Administration (TGA), issued a hazard alert regarding the company’s Oasys Midline Occipital Plate in July. An Oasys Midline Occipital Plate is a part of the Oasys System, which is used in spinal surgery to promote fusion and provide stabilization at the junction between the occipital bone […]
No one expected the birth of an orthopedic Superpower to go smoothly. The merger of Synthes and DePuy caused disruption in the spine business as different sales models collided. Some sales reps left. Now the company is suing them. Read it here.
The FDA has given Austin, Texas-based Ortho Kinematics, Inc. clearance to expand the company’s VMA (Vertebral Motion Analysis) system beyond the lumbar spine to the cervical spine. This may be good news for surgeons needing evidence with insurance payers. Ortho Kinematics is a diagnostic company focused on spine imaging informatics. The VMA system is a […]
Harvey Thomas, M.D., a neurosurgeon in Prescott, Arizona, is being sued for civil battery by a former patient for putting in an implant without disclosing that he was taking money from Blackstone Medical Inc. John Sherman, the patient, claims that Thomas failed to tell Sherman that he had a deal with Blackstone before performing surgery […]
On August 1, 2013, the FDA posted a Class 1 device recall notice for a DePuy Orthopaedics, Inc. femur device component. A Class I recall is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. LPS Lower […]
The FDA has rejected Memphis-based Wright Medical Group, Inc.’s PMA application for its Augment Bone Graft. “Augment Has Left the Building, ” wrote BMO Capital Market analyst (and one of our favorite headline writers) Joanne Wuensch. “Augment Exits Stage Wright, ” was Jefferies analyst Raj Denhoy’s headline. On August 8, 2013, the company issued a […]
Dan Goldberger is the new CEO of Bacterin International Holdings, Inc. He has been named inventor on more than 60 U.S. patents and holds a BS in Mechanical Engineering from the Massachusetts Institute of Technology and an MS in Mechanical Engineering from Stanford University.
An OIG warning, sensational news articles of physicians behaving badly, and recent hospital purchasing decisions are calling into question the viability and future of PODs. Are PODS down for the count? Or will they rise to fight again?
The Food and Drug Administration (FDA) has approved LDR Holding Corporation’s Mobi-C Cervical Disc for one-level indications in the U.S. The evidence from the clinical trial showed the device was non-inferior to fusion. But more significantly, patients with the disc returned to work a week faster than those who received a fusion. According to a […]
Avoiding “The Sequester” is Washington’s new pork. Medical device companies are going to pay about $100 million in Food and Drug Administration (FDA) user fees in 2013 to help cover the costs of being regulated. However, due to sequestration, the FDA can’t touch $85 million of that. That means a slowdown in device reviews, clearances […]
On August 6, 2013, the new management at Orthofix International N.V. announced that previously issued financial statements for certain periods of time should no longer be relied upon. When the company announced on July 29, 2013 that it was postponing release of second quarter financial results because it’s Board’s Audit Committee needed more time to […]
Johnson & Johnson (J&J) just learned an $85, 000 lesson about China’s new monopoly law on behalf of all device companies. A Shanghai court ordered the company to pay 530, 000 yuan ($85, 000) to a distributor who had sued the company for setting a minimum price the distributor could charge for surgical sutures. The […]
Controlling costs is the single biggest challenge to reforming health care. Whose job is it? A group from the Mayo Clinic surveyed thousands of physicians to see what they think about that question. The overwhelming response? “It’s not my job.” Read it here.
NuVasive, Inc. reported higher than expected second quarter revenue on July 30, 2013. But a disclosure that the Office of Inspector General (OIG) of the Department of Health and Human Services issued a subpoena in connection with a probe of false Medicare and Medicaid claims put a temporary halt to the company’s “Onward and Upward” […]
Medtronic Inc.’s Interventional Spine division will be promoting Amgen Inc.’s Prolia (denosub) for the next three years. According to a July 15, 2013 announcement, no later than July 31 Medtronic will begin promoting the drug to spine physicians treating patients who have a history of osteoporotic fracture. The drug is for use in postmenopausal women […]
On July 29, 2013, Orthofix International N.V. announced it was postponing the release of its financial results for the second quarter. The announcement stated the Audit Committee of the company’s Board of Directors needed more time to review “matters relating to revenue recognition for prior periods.” The Audit Committee could not predict the length of […]
Washington froze over and pigs were spotted flying over the Capitol dome on July 23, 2013. That’s when the Republican-controlled House of Representative’s Energy and Commerce subcommittee on health passed a seriously bipartisan bill to fix the Sustainable Growth Rate (SGR) formula. There are no reports that a floor vote on the bill has been […]
Zimmer Holdings, Inc., according to Bank of America analyst Bob Hopkins, just reported the company’s best revenue growth in years. The reported second quarter 4% increase in sales to $1.17 billion by the largest hip and knee maker in the industry continued the theme of stability in orthopedics. Net currency impact for the quarter decreased […]
In a fight between a physicians’ definition of medical necessity and the insurance company’s reluctance to pay—who ultimately wins? In a clearly partisan ruling, a California judge ruled for the insurance company saying that physicians can’t be trusted to make the medical necessity call. Is this guy serious? Read what we found in a case joined by LA County Medical Association.
DiscoCare claims another guilty plea. John Raffle, the former ArthroCare Corp. senior vice president of Strategic Business units, pleaded guilty in June to one count of conspiracy over the DiscoCare scandal. His plea was unsealed by the Justice Department on July 22; just days after the company’s former CEO Michael Baker and former CFO Michael […]
The 2.3% medical device excise tax required by the Affordable Care Act aka “Obamacare, ” has cost device companies an estimated $1 billion since the start of the year. That’s according to a July 15, 2013 report from three Washington, D.C.-based lobbying groups, the Medical Imaging & Technology Alliance (MITA), the Advanced Medical Technology Association […]
A Phase III study to demonstrate the efficacy for Spinal Restoration, Inc.’s Biostat systems has ended in disappointment. One of our readers in the study posted on July 7, 2013 that he had been notified the study was being discontinued due to no significant difference between the test group and control group, the company issued […]
Stryker Corporation’s reconstructive sales climbed 5.6% to $979 million in the second quarter of 2013. “We delivered another solid quarter of operational results with balanced sales growth across all segments and geographies, as well as strong cash flow performance, ” said the company’s President and CEO Kevin Lobo, on July 18, 2013. On a reported […]
Orthopedic sales of $2.39 billion at Johnson & Johnson’s (J&J) DePuy Synthes unit were up 48.9% for the second quarter. Excluding the impact of last year’s Synthes, Inc. acquisition, operational sales were up approximately 3%. Operationally, hip sales were up 4%, knees were up 2%, spine was down 2% and trauma was up 4%. According […]
The new era of physician/industry relationships starts August 1 when the Sunshine Act kicks in. Are you ready? Read what we found out about protecting proprietary information, research, educational programs and reputations. Read the checklist for physicians to make sure industry is reporting your payments accurately.
Bacterin International Holdings, Inc. has received FDA 510(k) clearance to market its OsteoSelect DBM Putty for use in spinal fusion. The putty, comprised of demineralized bone matrix (DBM) allograft is a moldable bone graft substitute designed to withstand irrigation while exhibiting osteoinductive properties for improved bone regeneration. In a July 16, 2013 press release, the […]
The ongoing saga of DiscoCare has now landed its biggest fishes. Michael Baker and Michael Gluk, the former CEO and former CFO, respectively, of ArthroCare Corporation have been charged with defrauding the company’s shareholders in a $400 million scheme by falsely inflating company earnings by tens of millions of dollars. Indictment On July 17, 2013, […]
Eight-foot four-inch, Wang Fengjun, Asia’s tallest man, has been hospitalized for a hip replacement in Zhengzhau, China. Various media outlets, including the Zhengzhau Evening News, reported on July 8, that 37-year-old Fengjun was diagnosed with osteonecrosis of the femoral head four years ago, which results from an interruption of blood supply. Repeated and prolonged pressure […]
SpinalMotion, Inc.’s two-day FDA orthopedic panel meeting scheduled July 24 and 25, 2013 has been cancelled. The FDA announced the cancellation on July 11 without comment. The company told us they have no comment on the cancellation. The company was to present evidence of the safety and effectiveness of the Kineflex/C Cervical and the Kineflex […]
Zimmer Spine, Inc. is now the exclusive distributor of SpineCraft, LLC’s APEX Spine System in the U.S., Canada, Australia and New Zealand. The system is a pedicle screw fixation system that provides immobilization and stabilization in the thoracic, lumbar and sacral spine regions, in the surgical treatment of acute and chronic spinal instabilities and deformities. […]
Biomet, Inc.’s net sales for the company’s fourth quarter rose 6% to approximately $784 million. Sports Medicine, Extremities and Trauma According to a July 11, 2013 company press release, Sports Medicine, Extremities and Trauma (S.E.T.) sales of $160 million were up 62.1% over the previous year. The large increase was due to the acquisition of […]
Promising to reduce costs, Biomet, Inc. released the ePAK single-use delivery system for internal fracture fixation on July 9, 2013. “We are excited to be the first orthopedic company to release a device in this category that addresses the needs of the orthopedic surgeon, patient, and the hospital system, ” said Wil Boren, president of […]
Who are the best and worst payers for physicians in America? Are denials going up or down? What can you do? The data knows. Read what athenahealth’s PayerView found out after reviewing millions of claim for 40, 000 physicians. Humana takes the top spot.
SpineNet, LLC of Winter Park, Florida, was warned by the FDA on May 31, 2013, that the company’s products are adulterated. The company, founded in 2007, is the developer of the SpineNet ACC (anterior cervical cage) System; an importer/repacker/relabeler of Apollon and Vane Pedicle Screw Systems; and a relabeler/distributor of the SpineNet Bone Marrow Aspiration […]
Baxano Surgical, Inc. has a definitive agreement with the U.S. Department of Justice regarding a subpoena dating back to October 2011 involving TranS1, Inc. (now merged with Baxano.). After reaching a tentative agreement with the feds on Christmas Eve 2012, the company will now pay $6 million over nine quarterly installments beginning this July. The […]
Smith & Nephew lost out to Wall Street investment banks when Dane Miller came storming back in 2007 to reclaim Biomet, Inc. Then Biomet tried unsuccessfully to buy Smith & Nephew. Now, reports from London are that the Wall Street investment bankers want to cash out. Follow the musical chairs here.
We recently wrote about complaints from orthopedic surgeons over Maintenance of Certification (MOC) programs and a lawsuit brought by the Association of American Physicians and Surgeons against the American Board of Medical Specialties (ABMS), seeking to stop the MOC program. (Certification: Scam or Public Safety: OTW 5/7/2013). Now the American Medical Association (AMA) has weighted […]
Fifty-five hospitals in 21 states will pay the government more than $34 million for allegedly cheating Medicare over kyphoplasty procedures. The Justice Department announced on July 2, 2013, that the hospitals improperly billed Medicare by keeping patients overnight for Medtronic Inc.’s outpatient kyphoplasty spine procedure. Kyphoplasty, according to the government, can be performed safely and […]
Claiming to overcome current challenges in graft containment and handling of cell-based tissue forms, on July 1, 2013 Orthofix International NV announced the full market release of Trinity Elite. Trinity Elite Allograft with Viable Cells and VersaShield Amniotic Membrane tissue forms will be distributed through the company’s Spine Fixation and U.S. Extremity Fixation distribution channels. […]
The FDA granted five PMA (premarket application) supplemental approvals in April, including two post-approval study protocols. Post-Approval Study Protocols NuVasive, Inc. received a study approval for its PCM Cervical Disc and Paradigm Spine, LLC, received the study approval for its Coflex Interlaminar Stabilization Device. Hips and Knee Systems DePuy Orthopaedics received two supplemental approvals for […]
Contested scientific hypotheses are a matter of opinion and are entitled to free speech protection. That’s the June 26, 2013 ruling of the 2nd U.S. Circuit Court of Appeals in ONY Inc. v. Cornerstone Therapeutics Inc. et al. Writing for a unanimous three-judge panel, Circuit Judge Gerard Lynch wrote: “As a matter of law, statements […]
Contested scientific hypotheses are a matter of opinion and are entitled to free speech protection. That’s the June 26, 2013 ruling of the 2nd U.S. Circuit Court of Appeals in ONY Inc. v. Cornerstone Therapeutics Inc. et al. Writing for a unanimous three-judge panel, Circuit Judge Gerard Lynch wrote: “As a matter of law, statements […]
Is another whistleblower behind the latest request by the United States Attorney for information from Medtronic, Inc.? In a June 24, 2013 SEC 10-K filing, the company disclosed that the U.S. Attorney in Minnesota requested information relating to the company’s compliance with the Trade Agreement Act (TAA). The filing also said the company was fully […]
Globus Medical, Inc. says it has launched the first expandable spacer on the market to offer the benefits of a traditional anterior implant, without a two-part disruptive surgical procedure. The LATIS implant is a minimally invasive (MIS) lumber interbody fusion spacer. The implant, for patients with degenerative disc disease (DDD), is inserted through an MIS […]
Brad Mason, Orthofix International N.V.’s new president and CEO, is re-booting the way the company is organized. The company’s operational business will now include: BioStim (stimulation products), Spine Fixation (spine implant products), Biologics (biologics products for all applications), International Extremity Fixation, and U.S. Extremity Fixation (orthopedic fixation systems). In a June 20, 2013 announcement, Mason […]
Aesculap Implant Systems, LLC has a new interbody system for ACDF (anterior cervical discectomy and fusion) procedures. The company says the CeSpaceXP, “fuses two proven materials, an innovative PlasmaporeXP osteoconductive porous Titanium coating and a PEEK-Optima radiolucent core, that delivers enhanced implant stability, artifact-free imaging, and an optimal scaffold for cervical fusion procedures.” According to […]
Six patent infringement lawsuits filed in Delaware disclosed that Medtronic sold over 500 kyphoplasty patents to an unknown company called Orthophoenix. Who are these guys? What did Medtronic get? What about the Kyphon Division? We find out.
A federal jury in Delaware decided that Globus Medical, Inc. owes DePuy Synthes Products, LLC $16 million for patent infringement. However, a formal judgment has not been entered and there are still motions to be resolved at hearings. In the June 14, 2013 verdict the jury found that prior versions of three products previously sold […]
Medtronic, Inc. has received CE Mark for a device used to treat patients with a severe form of spinal curvature to allow them to potentially stand up straighter without pain. On June 13, 2013, the company announced the launch of the ReDux Plier calling it the “first specialty-designed surgical instrument” in the spinal orthopedic industry […]
A Virginia podiatrist has been indicted in the ongoing investigation of fraudulent bone growth stimulator payments. Ilene Terrell, D.P.M., of Fredericksburg was charged on June 12, 2013 with manipulating patient medical records and then lying about it to a grand jury. The indictment also claims Terrell lied to Orthofix, Inc. auditors. Terrell allegedly prescribed an […]
A U.S. District Court has awarded Medtronic, Inc., a higher ongoing royalty rate than a jury had awarded the company previously in an ongoing patent fight with NuVasive, Inc. over NuVasive’s CoRoent XL implants and certain MaXcess retractors and related products. However, according to a June 12, 2013 announcement by NuVasive, the court awarded less […]
The FDA wants to share your clinical data with “non-FDA experts and other interested parties.” The agency says data gained from patients participating in clinical trials should be “maximized” for the benefit of society. So the agency is proposing to share clinical and preclinical data derived from marketing applications after de-identifying and masking that data. […]
Fernando Villamil, M.D., chief of the Orthopaedic Spine Service at Ashford Presbyterian Community Hospital in San Juan, Puerto Rico, is Lanx, Inc.’s new director of education for Latin America. He also joins the company’s Surgeon Advisory Board.
Medicare’s prospects are looking up. In their 2013 report, Medicare trustees projected…
Private health insurers want to dump fee-for-service payments systems. The only thing holding them back…
After a couple of successful intellectual property and marketing fights with competitors, MAKO Surgical Corp. is getting back to business by hiring a new senior vice president of marketing. On June 3, 2013, the company announced the appointment of Ian Dawson to the position.
A woman’s search for the model number of her failing knee replacement device opened a window into how health care journalists inform patients and the public about orthopedics. Are journalists well informed? Are the data and rules clear? We looked into the window.
ArthroCare Corporation’s former senior vice president of strategic business units, John Raffle, has pled not guilty to misleading investors to artificially inflating the company’s stock price. Federal prosecutors claim that Raffle and David Applegate, another former senior executive at the company, inflated publicly reported revenues through fraudulent sales to DiscoCare between 2006 and 2008. The […]
Blue Belt Technologies, Inc., after a bruising marketing squabble with MAKO Surgical Corp., announced on June 4, 2013 that the FDA has granted 510(k) clearance to market its Stride Unicondylar knee implant system. The company said the implant system will be co-marketed with Blue Belt Technologies’ NavioPFS precision orthopedic surgical system which has been commercially […]
Zimmer Holdings, Inc. enlarged the company’s footprint in small bones with the acquisition of Tuttlingen, Germany-based Normed Medizin-Technik GmbH.
If you don’t know where the pain generator is, then you can’t use professional guidelines and standards and FDA labeling to take away a physician’s license to practice medicine. That’s the defense’s argument as the bluebloods of spine squared off against the new kids on the block in Jersey.
TranS1 Inc. is now Baxano Surgical, Inc. after the company announced on May 31, 2013 that it completed its acquisition of Baxano, Inc.
The FDA has been conducting more inspections over the last four years, resulting in more warning letters to medical device manufacturers. That’s according to FDA inspection records showing agency medical device quality inspectors have issued warning letters to manufacturers at an increasing rate since 2005.
The FDA has been conducting more inspections over the last four years, resulting in more warning letters to medical device manufacturers. That’s according to FDA inspection records showing agency medical device quality inspectors have issued warning letters to manufacturers at an increasing rate since 2005.
RACs (Medicare Recovery Auditors) racked in $1.37 billion in overpayments and returned $65.4 million in underpayments during the first 6 months of the government’s current fiscal year.
NuVasive, Inc. launched its Maximum Access Surgery Posterior Lumbar Interbody Fusion (MAS® PLIF) procedure on May 31, 2013. After an initial limited launch around the U.S., the procedure is now available for patients and surgeons in Australia, Switzerland, Italy, Germany, and the United Kingdom.
After years of off-label use, the FDA’s orthopedic panel finally recommended on May 22, 2013, that the FDA acknowledge what practioners are already doing and officially downclassify thoracolumbar pedicle screw spinal systems. The devices are intended to treat degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1, or […]
Lanx, Inc. says it is launching the first modular anchored interbody device for lateral fusion. The Timberline MPF Lateral Modular Plate Fixation System enhances the Timberline system platform, which has seen “strong” adoption since its launch last year.
Did the FDA kill CoAxia using the new de novo process? Despite reducing mortality rates in patients 2 to 1 over standard of care, the FDA pushed CoAxia into the new de novo process. In retrospect, it also killed the company. Attorney Mark DuVal, is warning clients to beware the de novo process lest it devours you.
A Milwaukee spine surgeon has been indicted for lying to payers about minimally invasive spine procedures requiring nerve monitoring. Cully R. White, D.O. was charged with 13 counts of health care fraud by a federal grand jury in Milwaukee, Wisconsin.
Medtronic, Inc.’s fourth quarter spine revenue of $811 million was flat, but the company gained market share for the first time since the fourth quarter of 2007. That math doesn’t say much good about the overall spine market. Outperforming the Market If you exclude sales of balloon kyphoplasty, the company’s core spine business grew in […]
Benvenue Medical, Inc. just completed its 12-month follow-up on patients in the company’s KAST clinical trial. The results? The company announced on May 21, 2013 that the study ended early because the trial met the pre-determined stopping rules (non-inferiority).
The drip, drip, drip of former Orthofix, Inc. employees convicted of cheating Medicare to sell bone growth stimulator devices continues. The U.S. Attorney’s Office announced that a former territory manager, pled guilty to health care fraud and paying kickbacks from 2005 through 2011 while selling Orthofix bone growth stimulators.
Board certified surgeons and pain interventionists aren’t the only ones having a scope of practice argument over who is best qualified to treat patients. While some orthopedic surgeons assert that the government is limiting residency slots and could force medical school graduates into primary care, a study reported in the May 16, 2013 issue of […]
DePuy Orthopaedics, Inc. is discontinuing the use of metal liners in the company’s Ultamet metal-on-metal and Complete ceramic-on-metal hip systems.
As if orthopedic device sale reps don’t have enough to worry about, Wright Medical’s CEO, Robert Palmisano announced on April 30, that the company would now be marketing and selling their orthopedic devices directly to the hospital’s paymasters. Read the details here.
Improving federal government finances may open a brief window to overhaul Medicare’s flawed physician payment system. In the midst of rising government revenue from tax collections and bailout paybacks shrinking the federal deficit faster than expected, the Democrat chair and Republican leader of the Senate Finance Committee, Max Baucus and Orrin Hatch, sent letters to […]
The nation’s health care piggy bank is looking a little better. Health care spending growth slowed in the U.S. by more than $500 billion between 2003 and 2012. If trends continue for the next decade, current projections of spending may be too high by $770 billion.
On May 8, 2013, the Department of Health and Human Services (HHS) released data showing significant variation across the country and within communities in what hospitals charge for common inpatient services, including orthopedic services.
Almost 50 full time employees have lost their jobs at Zimmer Holdings, Inc.’s Warsaw, Indiana, operations. The Journal Gazette of Ft. Wayne, Indiana, reported on May 10, 2013 that Zimmer cut less than 50 full-time jobs at its Kosciusko County operation, which employed about 1, 500 as of December 31, 2012. Worldwide, the company employs […]
Imagine the massive effort required to spend a full day presenting evidence to the FDA orthopedic panel to prove your device is safe and effective. SpinalMotion, Inc. is doubling down and going for two days in July.
NuVasive, Inc. is verticalizing its manufacturing model by buying one of its implant suppliers. On May 6, 2013, the company announced it was acquiring ANC, LLC, a spine implant manufacturer based in Dayton, Ohio.
DePuy Orthopaedics, Inc. actually had some good hip news on May 3, 2013, when the company announced FDA Pre-Market (PMA) Supplemental Approval for its Ceramax ceramic-on-ceramic hip system.
New Jersey continues to be ground-zero for credentialing battles as the Association of American Physicians & Surgeons sues the American Board of Medical Specialties over the Board’s certification program. The complaint? Certification programs principally enrich private corporations at the expense of doctors. Really? We lift the veil.
Zimmer Holdings, Inc. announced on May 2, 2013 that the company has acquired the assets of West Chester, Pennsylvania-based and Viscogliosi Brothers, LLC-founded, Knee Creations, LLC.
NuVasive, Inc. and Globus Medical, Inc., involved in litigation with each other and in a fight for market share with Medtronic, Inc., reported 5.2% and 10.9% revenue increases, respectively, for the first quarter of 2013.
Wenzel Spine, Inc. has launched its VariLift-C stand-alone zero-profile expandable cervical interbody fusion device in the U.S. The company received FDA clearance in January 2013.
Medtronic Inc.’s spinal business launched several new product line additions to the company’s Vertex Select Reconstruction system at the 81st American Association of Neurological Surgeons (AANS) Annual Scientific Meeting in New Orleans. The company also launched the MAST Aligned procedure at the meeting on April 29, 2013.
What, exactly, is the scope of practice for interventional spine physicians? The new front line in this battle is New Jersey. The new poster child is Dr. Richard Kaul. This is a Runyon-esq melodrama punctuated with charges of greed, politics and restraint of trade against, among others, the former heads of NASS and the AMA.
ISTO Technologies, Inc. and Zimmer Holdings, Inc. have reached a fork in the road. And they’re taking it. On April 29, 2013, ISTO announced that the companies have called off their collaboration and will go their own ways to develop products to repair cartilage defects. ISTO is assuming full control of the DeNovo ET engineered […]
SpineCraft, LLC announced on April 24 that Zimmer Spine will begin distributing, on an exclusive basis, the company’s APEX Spine System in the U.S., Canada, Australia and New Zealand.
SpineCraft, LLC announced on April 24 that Zimmer Spine will begin distributing, on an exclusive basis, the company’s APEX Spine System in the U.S., Canada, Australia and New Zealand.
Zimmer Holdings, Inc. and Stryker Corporation reported first quarter revenue the week of April 22nd. The results were uneventful, expected and point to a happy recovery of the orthopedics markets.
Not all vertebral compression fractures (VCFs) are the same. For instance, some have different vertebral height profiles. In a peer-reviewed article published in the April edition of Techniques in Regional Anesthesia and Pain Management (Volume 16/Number 2), Benvenue Medical, Inc.’s Kiva and Blazer systems were highlighted as being “among the most innovative experimental and commercial […]
Five physicians, including a podiatrist and two hospital executives from Chicago-based Sacred Heart Hospital have been arrested for allegedly conspiring to pay and receive illegal kickbacks in exchange for the referral of patients insured by Medicare and Medicaid. Gary Shapiro, the U.S. Attorney for the Northern District of Illinois made the announcement on April 16, […]
Is the PILD procedure for LSS (percutaneous image-guided lumbar decompression for lumbar spinal stenosis) reasonable and necessary? The Centers for Medicare and Medicaid Services (CMS) want you to tell them. The agency initiated a national coverage analysis (NCA) of PILD for LSS on April 5, 2013. There is a 30-day public comment period. CMS is […]
Forty-four months ago, Intermountain Healthcare of Utah self-reported potential violations under the Stark Law to the government. On April 3, 2013, the Department of Justice and the Office of Inspector General of the Department of Health and Human Services (OIG) reached a $25.5 million settlement with the largest health system in the state. The system […]
On April 16, 2013, DePuy Orthopaedics, Inc., the biggest orthopedic player on the block reported relatively flat sales for the first quarter of the year, if you exclude Synthes sales. Sales were up 60% on an operational basis had Synthes been included. The results continue to confirm to analysts that the orthopedic market has stabilized. […]
Not guilty! DePuy Orthopaedics, Inc. announced on April 16, 2013 that a jury in Cook County Illinois returned a verdict in favor of the company in a product liability lawsuit over the company’s ASR metal-on-metal hip system. It’s the second jury to reach a decision. On March 8, 2013 the first jury in Los Angeles […]
Medtronic Spine employees were informed on April 4, 2013 that some of them would be losing their jobs in a restructuring to be finalized in May.
Physicians, device makers, hospitals and insurers are all spending big bucks in Washington to influence where healthcare dollars are spent in the next federal budget. Money buys influence. Who is spending the most and getting results? We looked at the numbers.
Stryker Corporation announced on April 10, 2013 that the FDA has classified the voluntary recall of the company’s ShapeMatch Cutting Guides as a Class I Recall. A Class I Recall, according to the FDA, is a situation in which “there is a reasonable probability that the use of or exposure to a violative product will […]
On April 9, 2013, the biggest insurer in the U.S. and a large chain of hospitals announced they are teaming up to figure out if they’re getting their money’s worth from manufacturers of medical devices. Mark West, president of the joint venture called SharedClarity, reportedly said one might call this the first stages of medical […]
Biomet, Inc.’s sales increased 9% on a reported basis to $772 million during the first quarter (Biomet’s third fiscal quarter) of the year. Excluding the DePuy trauma acquisition, sales were flat. On a reported basis, knees and hips were flat, spine declined 4% and sports, extremities, trauma (S.E.T.) excluding the trauma acquisition was up 8%. Extremity sales grew 18%, with 26% growth in the U.S.
Bill Jellison will be Stryker Corporation’s next CFO starting April 22, 2013.
The FDA wants you to invite them for a formal training visit to your research, clinical, manufacturing and health care facilities to observe firsthand how medical devices are designed, developed and utilized. They (promise/swear/cross-their-hearts-and-hope-to-die) that these visits are not a mechanism for the agency to inspect, assess, judge, or perform a regulatory function (i.e., compliance […]
Ortho robot makers are at war in federal courts from coast to coast. Accusations of disloyalty, deceit, cheating and theft of trade secrets are flying as Stryker Corporation and MAKO Surgical Corp. try protect their hard earned turf. Who is the upstart that sparked such a conflagration?
MAKO Surgical Corp. has won its court battle with Blue Belt Technologies, Inc. and former employee, Jeff Gellman. On April 4, 2013, MAKO announced that it had obtained an Order Granting Permanent Injunction keeping Blue Belt from employing Gellman and requiring the destruction of all proprietary MAKO business information in Blue Belt’s possession.
Rochester, Minnesota-based BiosCompass, Inc. has acquired the IP (intellectual property) for Adcon Gel from AaP Implanate AG and EMCM B.V. The product is a biocompatible, resorbable gel that provides a physical barrier to inter-tissue adhesions by inhibiting fibroblast migration onto and around neural or tendinous structures. According to the company, the design of the gel […]
Bacterin International Holdings, Inc. is looking for someone to replace company founder Guy Cook. In an April 1, 2013 SEC filing, the company stated that Cook has provided notice of his intention to resign as president and CEO once a successor is selected. The company is retaining an executive search firm to identify potential candidates. Cook will continue to work with the company as a consultant and chairman of the company’s board after the new CEO is hire.
The cumulative benefit to U.S. volume surgical procedures due to Obamacare will increase 3.6% by 2022 and will likely offset the 2.3% medical device tax under the new healthcare law. That’s not the political rhetoric of a partisan political pundit, but the result of a new analysis from one of Wall Street’s top orthopedic analysts, Larry Biegelsen of Wells Fargo Securities. And we don’t think Larry was kidding, even though he announced the new analysis on April 1, 2013.
The 81st Annual Meeting of the American Academy of Orthopaedic Surgeons took place in a background of a changing healthcare landscape where payers rule and value counts. Josh Jacobs, M.D., the Academy’s new leader has a plan. Oh yeah, there were also new knees, lots of them. Read on.
Device manufacturers got a false alarm in mid-March when the U.S. Senate voted overwhelmingly to repeal the 2.3% medical device tax. Unfortunately, the vote was meaningless, as the measure was part of a Democratic spending bill that has no chance of passing the Republican-controlled House of Representatives. The byzantine rules of order of Congress don’t […]
On March 28, 2013, the Centers for Medicare and Medicaid Services (CMS) published the latest directive on mandatory payment reductions in the Medicare FFS program under “Sequestration.” As required by law, President Obama issued a sequestration order on March 1, 2013 requiring across-the-board reductions in federal spending.
On March 27, 2013 K2M, Inc. announced a “major” expansion of the company’s U.S. biologics portfolio with the launch of the Venado Foam Strips and Granules Bone Graft systems. Company President and CEO Eric Major said the launch enables the company to meet a “significant” demand from surgeons. The products, according to the company, represent […]
The Office of Inspector General (OIG) fired a “Warning Shot” on March 26, 2013, for physician-owned distributors (PODs) that don’t follow appropriate investor guidelines. In a “Special Fraud Alert”, the OIG reiterates its longstanding position that it views PODs as “inherently suspect” under the anti-kickback statute.
Newly-minted Orthofix International N.V. President and CEO Brad Mason got to announce his first new product launch on March 20, 2013. The Contours PHP (Proximal Humeral Plate) is being released through the company’s international distribution network. The plating system, for the treatment of the proximal humeral fractures, consists of anatomically contoured left and right plates […]
Zimmer Holdings, Inc. has been awarded a $69.2 million contract to supply the Department of Defense with orthopedic products. The award was a modification of the second option year of an existing contract and is a fixed-price with economic-price-adjustment. The contract is an indefinite-delivery/indefinite-quantity contract capped at $69.2 million for hips, knees, spine, and extremity […]
Minimally invasive spine surgery pioneer Anthony Yeung, M.D., and his wife, Eileen, are donating $2.5 million to develop a comprehensive state-of-the-art spinal endoscopic surgical center at the University of New Mexico (UNM).
Biomet, Inc., with its Vanguard knee system and OrthoSensor, Inc. with its wireless VERASENSE sensors, are forming a co-promotion partnership to, according to a March 18, 2013 press release, “improve knee replacement surgery.” VERASENSE is a trial bearing designed for use with the Vanguard Complete Knee System, which is embedded with sensors and microelectronics to […]
You and your partners have agreed to sell your practice to a local hospital. Then you discover your partners changed the deal on you. So you decide to sue your former partners, including Gender Knee developer, Robert Booth, M.D. It’s a mess. Here’s what we know so far.
The FDA sent NuVasive, Inc. a warning letter on March 12, 2013 related to labeling claims not cleared through any of the company’s Affix Spinous Process Plate system 510(k)s. The company announced the warning letter on March 18, 2013 and said the regulatory action came from an FDA inspection of the company’s San Diego, California […]
Knees to remember and hips to forget will likely be the big stories on the convention floor at the annual meeting of the American Academy of Orthopaedic Surgeons (AAOS) the week of March 19, 2013 in Chicago, Illinois. Zimmer Holdings, Inc., and DePuySynthes are both hoping to attract surgeons to their booths to check out […]
In a move to provide “Significant non-dilutive” funding, VertiFlex, Inc. is selling certain spinal implant technologies to Stryker Corporation. Earl Fender, VertiFlex president and CEO and former worldwide president of DePuy Spine, said in a March 13, 2013 announcement that the sale of these “innovative assets to Stryker represents the beginning of a new era […]
Just in time for the upcoming annual meeting of the American Academy of Orthopaedic Surgeons, Stryker Corporation is launching the ICONIX all suture anchor platform with IntelliBraid technology.
Stryker Corporation has launched the Universal SMARTLock Hybrid MMF System invented by Jeffrey Marcus, M.D., Associate Vice-Chair of Surgery at Duke University. The maxillomandibular fixation (MMF) device combines elements of both arch bars and MMF screws, stated the company announcement.
Stryker Corporation announced on March 12, 2013 that its Instruments division has received a warning letter from the FDA related to an FDA site visit made during a November 2012 inspection at its Portage, Michigan, location. The letter concerns quality system and cites Stryker for failing to notify the FDA of a product recall, and […]
A new cervical spinal implant designed by Fred Geisler M.D., Ph.D. of the Chicago Back Institute at Swedish Covenant Hospital, has been introduced by Aesculap Implant Systems, LLC. The PL-AGE system is a stand-alone device intended for use in anterior cervical spinal fusion procedures at one level from C3-C7. Dr. Geisler, according to a March […]
The jury in the ASR metal-on-metal trial has reached a verdict and awards $8.3 million to the plaintiff. DePuy is guilty of designing a faulty device, but adequately warned patients and surgeons of the dangers. Read what the lawyers for the two sides told the jury in their closing arguments and how DePuy defended itself.
The FDA Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee voted 12-9 on March 5, 2013, to recommend that the evidence did not support the use of calcitonin salmon nasal spray for the treatment of osteoporosis. The panel said there is little evidence they work and may actually […]
The jury in the DePuy Orthopaedic, Inc. ASR hip trial returned a mixed verdict on March 8, 2013, after a five week trial and has awarded Loren Kransky $8, 338, 000 in compensatory damages. Kransky’s lawyers had asked jurors for $338, 000 in economic damages, $5 million in economic damages for pain and suffering, and […]
“The combination of TranS1 Inc. and Baxano, Inc. creates a pure play MIS spine company with much greater scale, ” Ken Reali, Trans1’s CEO and president told OTW about the surprise announcement that Trans1 was acquiring Baxano. TranS1 announced a definitive agreement on March 4, 2013, to acquire Baxano, a privately-held company that manufactures and […]
Lanx, Inc. has launched the first anterior cervical fusion system to feature three low-profile plate options. That’s the claim made in a March 4, 2013 statement from the company announcing the launch of its Alta Stand-Alone ACDF system for a less invasive approach to fusion. The system is a stand-alone integrated plate and interbody system […]
Investors of medical device companies may be greeting the automatic budget cuts of sequestration with a big yawn and the White House is accused of fear mongering by Republicans, but Steve Ubl, the head of AdvaMed, the Advanced Medical Technology Association, is worried. In a March 2, 1013 interview with Minnesota’s Star Tribune, Ubl said […]
The DePuy ASR hip trial has reached the halfway point as plaintiff’s lawyers rest their case. Now the defense takes its turn. DePuy has taken its lumps, but maintains it did nothing wrong. Read the evidence the jury has heard and what it might mean to the other 10, 000 cases pending against DePuy.
If you own shares in a mutual fund that includes a company for whom you are a clinical investigator for an FDA-sponsored investigation, do you have to disclose that? Can a literature report be considered a covered clinical study? The FDA’s got the answers for you in a new guidance. The “Guidance for Clinical Investigators, […]
March has arrived and Congress hasn’t passed an alternative deficit-reduction package. That means Medicare provider payments began being cut by 2% on March 1, 2013 as required by the Budget Control Act of 2011 (Sequestration). The health care industry will be impacted by government program spending reductions of $3 billion in the current fiscal year, […]
It’s not for an orthopedic medical device, but Medtronic, Inc. has received landmark FDA approval under new draft guidance to conduct an early feasibility study. The approval to study Medtronic’s Native Outflow Tract Transcatheder Pulmonary Valve (TPV), represent the first-ever FDA approval of an investigational device exemption (IDE). Investigational Device Exemption The intent of the […]
The FDA initiated an “urgent” Class 1 Medical Device Recall of DePuy Orthopaedic, Inc.’s LPS Diaphyseal Sleeve on February 15, 2013. The agency made the recall public on February 22, 2013. The sleeve is intended for use with the LPS System which is an end-stage revision knee product that allows surgeons to reconstruct severe soft […]
When spine surgeon Andrew Cappuccino and NuVasive, Inc. had a messy breakup in 2011, it made big news in the small spine industry community. Cappuccino’s departure to Lanx, Inc., was followed by the defection of NuVasive sales reps. What happened? The lawsuits tell all.
While a jury listens to evidence about Johnson & Johnson’s DePuy Orthopaedics’s failed ASR metal-on-metal hip replacement device in a Los Angeles courtroom, the company issued a field safety notice on January 15, 2013 for physicians and consumers for the Adept 12/14 Modular Head used in total hip replacement. This was done after reviewing revision […]
DePuy Synthes Joint Reconstruction has introduced the Global Unite Platform Shoulder Arthroplasty System. The system is a modular system that allows 72 different sizing configurations. A suture collar allows secure anatomic reconstruction of the tuberosities and helps return the shoulder to a natural anatomical position.
Medtronic Inc.’s core spine business continued to stabilize in the third quarter of 2013. Revenue of $639 million was flat on a constant currency basis. Total spine sales of $753 million declined by 3% on a constant currency basis (-4% reported) as Infuse and kyphoplasty continue to drag down overall sales.
The Collaborative Spine Research Foundation was formed in 2011 by neurosurgeons and orthopedic surgeons to advance the science and practice of spine care. Most importantly, it would be a group that made decisions about research independent of industry influence. The foundation was founded by the Neurosurgery Research and Education Foundation and the Orthopaedic Research and […]
Bacterin International Holdings, Inc. announced on February 11, 2013, that the company has received a subpoena from the Office of the Inspector General of the U.S. Department of Health and Human Services (“OIG”) in connection with an investigation into possible false or otherwise improper claims submitted to Medicare. In an SEC 8K filing, the company […]
In a time of great financial challenges for spine surgeons, the Laser Spine Institute had seemingly solved the riddle of bringing more patients in their doors and revenue in their coffers. Then came The Hulkster to question whether or not the institute delivers what it promises. We looked inside the lawsuit.
Orthofix International N.V., issued a new release in January announcing the company’s new anterior cervical interbody system which incorporates the benefits of PEEK with potential ingrowth from porous titanium endplates. We published the announcement shortly thereafter with a photo of the Construct Mini PEEK Titanium Spacer System being used in a multi-level case.
Just a week after a Smith and Nephew (S&N) public statement attributed the cut of 63 company jobs in Memphis to the 2.3% medical device excise tax, the company’s CEO Olivier Bohoun told analysts during a telephone conference call on February 7 that the Memphis media reports were “just wrong.” Bohoun was asked about comments […]
Smith & Nephew, plc (S&N) reported fourth-quarter sales declined 3% to $1.08 billion from $1.11 billion the previous year. The revenue decline was partially attributed to the absence of the company’s biologics and clinical therapies business, spun out last May as Bioventus LLC. In November the company announced the acquisition of Healthpoint Biotherapeutics for $782 […]
Zyga Technology, Inc. has completed enrollment in the Glissade trial to demonstrate performance of facet resurfacing.
Smith & Nephew (SNN) is laying off almost 100 workers at its plants in Memphis, Tennessee, and Andover, Massachusetts.
Now that the first $97 million of the new device tax has been collected by the government, it raises the questions of who is paying the price of the 2.3% tax. We’ve seen numerous reports that thousands of laid-off workers from device companies have paid for the tax with their jobs. Other reports from device […]
Orthopedics’ biggest trial is finally underway. The first witness has been called. The plaintiffs say that DePuy’s ASR metal-on-metal hip had a flawed design which the company knew about. The defendants have a strong counter argument. Bottom line: what did DePuy know and when did they know it?
over the previous year’s quarter. Hips and knees came in down 1% and up 1%, respectively. The company likely lost some market share during the quarter.
The government’s take on the first bi-monthly payment of the medical device tax came in at about $97 million. That’s the report from AdvaMed on Tuesday, January 29, 2013. Will orthopedic device makers make up the cost in higher sales? Wells Fargo’s analyst Larry Biegelsen recently took a crack at answering that question and concluded […]
The FDA announced on January 23, 2013, that the agency would not appeal the landmark federal circuit court Caronia decision that the First Amendment protects truthful speech about the off-label use of FDA-approved products. Alfred Caronia was prosecuted and convicted of conspiring to introduce a misbranded drug into interstate commerce. He was caught on tape […]
The British say “no thanks” to a U.S. style premarket approval (PMA) process. The tension between the FDA’s two goals of “promoting” and “protecting” public health leans heavily on the “protecting” side with a vigorous PMA process. Once devices are approved, a modest level of post approval surveillance is required. Some U.S. patient advocate groups […]
Stryker Corporation had a very good fourth quarter. After tamping down expectations during his first quarterly call with analysts in October, Stryker’s new President and CEO Kevin Lobo was able to beat expectations in his second analyst call on January 23, 2013.
The heat on Johnson & Johnson (J&J) to settle the DePuy ASR metal-on-metal hip lawsuits is building as the next trial is set to start on Friday, January 25, 2013, in a California state court. The figure of $2 billion for a potential settlement was being reported by Bloomberg News on January 19. The impending […]
Zimmer Holdings, Inc.’s spine division introduced the Zimmer V2F Anterior Fixation System on January 22, 2013. The system, borrowing from a proprietary Zimmer trauma technology, is the company’s first lateral plate system for the spinal trauma segment. The V2F System consists of a wide range of plates and screws designed to better match the varying […]
If Biomet, Inc. is the canary in the coal mine for orthopedics, then DePuy Synthes Companies is the bellwether. Results for the bellwether were good in the fourth quarter of 2012 as the company reported sales of $2.388 billion for the quarter. Excluding the impact of the Synthes acquisition in June, those revenues represented a […]
Physician-owned hospitals were by far the BEST in a recent CMS Quality Survey. Some famous hospitals landed near the bottom. Which hospitals were deemed the best or the worst in Medicare’s $1 billion incentive lottery? Read all the results here.
Calling it “Revolutionary, ” Zimmer Holdings, Inc. announced the 510(k) clearance of the iASSIST Knee, the company’s personalized guidance system for knee replacement procedures. According to a company statement on January 17, the technology comprises small electronic disposable pod components that are used at the site of knee replacement surgery, providing instantaneous, accurate alignment validation […]
The FDA has decided that makers of metal-on-metal total hip replacement systems should be ordered to submit premarket approval (PMA) applications. On January 17, 2013, the FDA issued the proposed order along with a series of recommendations to orthopedic surgeons and patients thinking about getting a metal-on-metal hip or dealing with already implanted devices. Orthopedic […]
Stryker Corporation has struck into the middle trauma and spine markets of the Middle Kingdom by offering to acquire Chinese-based Trauson Holdings Company Limited for approximately $685 million. Trauson is a leading manufacturer of instruments and implants for trauma and spine, and the market leader in trauma for the middle market. Founded in China in […]
Hulk Hogan is smacking down the Florida-based Laser Spine Institute. The Hulkster is suing the institute for persuading him to have half a dozen of “unnecessary and ineffective” spinal operations. After all the procedures, his back problems worsened, according to his lawsuit filed on January 14 in Florida state court in Clearwater. Bloomberg News reported […]
The Austin American-Statesman reported on January 10 that Zimmer Spine is closing its Austin, Texas facility. Zimmer Holdings, Inc. acquired Austin-based Abbott Spine in 2008 for $360 million. About 100 people are currently employed at the facility. An undisclosed number of workers from Austin will be given the opportunity to relocate to the Twin Cities […]
AxioMed Spine Corporation has raised $3.6 million in new financing from current and new investors. The Garfield Heights, Ohio, company formed in 2001 is developing products, according to a January 10 press release, “to restore spinal function in patients with degenerative spine disease by advancing the standard of care beyond fusion and first generation total […]
Over 10, 000 lawsuits have been filed against manufacturers of metal-on-metal hips. The first scheduled trial against one of the manufacturers, DePuy Orthopaedics, took a surprising twist in a state court in Maryland. Read what happened and what it might mean for the next scheduled trials.
Stryker Corporation announced on January 9 that it had set up a third-party administrator claims program related to the June 2012 recall of the Rejuvenate and ABG II modular-neck hip stems. The company also disclosed that it recorded a charge of $174 million during the fourth quarter of 2012 related to the recall. After the […]
Orthofix International N.V. has launched an anterior cervical interbody system that incorporates the benefits of PEEK imaging capabilities with potential of bone ingrowth from porous titanium endplates. The company announced the new system called the Construx Mini PEEK Titanium Composite (PTC) Spacer System on January 9, 2013. The system will be distributed through the company’s […]
What does getting caught defrauding Medicare of more than $250, 000 get you? For Derrick Field, it got him two years of probation and five months of home confinement. Field also has to pay a fine of $4, 000 and forfeit $40, 000. While the sentence doesn’t seem overly harsh, Field is probably done selling […]
Biomet, Inc.’s second quarter results are an “incremental positive” for the orthopedic industry, per Wells Fargo analyst Larry Biegelsen. The company reported a 9% increase in net sales to $790.1 million earlier on the same day.
Scott Bruder, M.D., Ph.D. has been a professor of biomedical engineering, an FDA Advisory Panel member, chief science and technology officer and a seasoned science executive with Becton, Dickinson and Company, DePuy, Inc., Anika Therapeutics, Inc. and Osiris Therapeutics, Inc.
Everybody’s heard about the “Doc Fix”, tax increases and Medicare’s spending cut delays passed by Congress to avoid the “Fiscal Cliff.” But buried in the legislation are 5 laws that you may not have heard about. And they could change your practice.
Soft Tissue Regeneration Inc., (STR) of New Haven, Connecticut, is chasing one of the Holy Grails of orthopedics, repair of musculoskeletal soft tissue injuries. On January 3, 2013, the company announced FDA clearance to market its STR Graft, a biodegradable scaffold used for, “soft tissue augmentation and rotator cuff repair.” The STR Graft, according to […]
Congress passed a one-year “doc fix” on New Year’s Day. The President is expected to sign the legislation immediately. The House of Representatives, by a vote of 257 to 167, approved the Senate’s package to put off a 26.5% Medicare physician pay cut by cutting billions from other Medicare providers, including hospitals, pharmacies and dialysis […]
Stryker Corporation’s Polish branch is being investigated for allegedly offering bribes to hospital officials across Poland in order to secure deals. Leszek Golawski, the prosecutor in the southern city of Katowice in Poland, is reported by the Associated Press (AP) on December 31 to have confirmed that dozens of private apartments and offices have been […]
The Centers for Medicare and Medicaid Services (CMS) has announced tentative plans on how to handle 2013 Medicare claims in the absence of Congress providing a “doc fix.” “Given the current progress with the legislation, CMS must take steps to implement the negative update, ” stated a recent CMS update. Under current law, physicians will […]
TranS1 Inc. has reached a tentative agreement to settle a federal investigation for $6 million. The U.S. Department of Justice, on behalf of the Department of Health and Human Services, Office of Inspector General, issued a subpoena against the company in October 2011. The subpoena was issued under the authority of the federal healthcare fraud […]
Surgeons and hospitals using Zimmer Spine, Inc.’s PEEK Ardis Inserter instruments should immediately stop using the inserters and return them to Zimmer Spine. That’s the warning in an urgent worldwide recall issued by the company on December 20, 2012, of all 315 units of the inserter sold since 2008. The inserters are being recalled because […]
Pioneer Surgical Technology, Inc. has expanded its foothold in Germany. On December 21, the company announced the creation of Pioneer Surgical Technology Deutschland GMBH. With offices located in Konstanz, Germany, the company is positioned, according to the announcement, to put Pioneer closer to its surgeon and hospital customers in Germany by establishing a commercial center […]
NuVasive, Inc’s CoRoent Large Impacted and CoRoent Large Tapered titanium alloy implants have been given the official green light in Japan. The company announced on December 17, regulatory shonin approval from the nation’s regulatory agency. Shonin allows NuVasive to participate in the world’s second largest spine market with cervical solution. In 2005, according to law […]
Ortho Kinematics, Inc. closed on more than $2 million in new Series B financing, according to a news release on December 18. The privately held company in Austin, Texas, focuses on spine imaging informatics by leveraging spine biomechanical data to, hopefully, improve the diagnosis and treatment of back pain. The funds will support the continued […]
The Internal Revenue Service (IRS) has published final regulations on the medical device excise tax that will begin after January 1, 2013. In order to pay for coverage for the uninsured, the new health care law provided that any “manufacturer, producer, or importer” of taxable medical devices shall be required to pay a tax equal […]
The third time’s the charm for Orthofix International N.V. After a federal judge in Boston rejected two previous agreements between the government and Orthofix to resolve an investigation regarding the company’s bone growth stimulator business, the judge finally blessed the agreement over the December 16 weekend. The company will pay approximately $43 million to resolve […]
Sales rep off-label discussion protected by the First Amendment? Most definitely say federal appeals court judges. But will the Supremes make this settled law of the land? They will get their chance to review but in the meantime possibilities for medical product education and innovation just got brighter.
Namal Nawana, the recently departed head of DePuySynthes Spine, has a new job as COO of Alere, Inc.
Changes in board membership at the large orthopedic companies are usually not big news. But Zimmer Holdings, Inc.’s recent appointment of Gail Boudreaux to the board caught our attention. Boudreaux is the executive vice president of UnitedHealth Group and CEO of UnitedHealthcare.
NuVasive, Inc. has made “significant” leadership changes to its sales management team with a new leader for U.S. sales and a new vice president of strategic sales and operations. These personnel changes come after the company was surprised with less than expected sales results for the third quarter. Chairman and CEO, Alex Lukianov then took […]
The orthopedic robotics market grew by one on December 10 as the FDA cleared Blue Belt Technologies, Inc.’s robotic-assisted NavioPFS orthopedic surgical system for unicompartmental knee replacement. The clearance covers only partial knee replacement, but a Blue Belt press release said the company anticipates expanding further into orthopedic surgery. Blue Belt received European CE Mark […]
The orthopedic robotics market grew by one on December 10 as the FDA cleared Blue Belt Technologies, Inc.’s robotic-assisted NavioPFS orthopedic surgical system for unicompartmental knee replacement. The clearance covers only partial knee replacement, but a Blue Belt press release said the company anticipates expanding further into orthopedic surgery. Blue Belt received European CE Mark […]
2012 was a particularly eventful year for orthopedic healthcare providers, companies, analysts, regulators and, of course, the all-important payer community. What events defined these past 12 months? Here are the events and the stories which, in our opinion and those of our readers, defined this industry in 2012. Of course, please let us know if you agree or disagree.
The U.S. Agency for Healthcare Quality and Research (AHRQ) is reopening the debate about the safety and effectiveness of spinal fusion. Their reports are often used by commercial payers in determining coverage policies.
Medtronic, Inc.'s spine unit launched their latest addition to its cervical surgical technique portfolio, the CERVICAL FACETLIFTSM ID/S surgical technique, at the 40th annual meeting of the Cervical Spine Research Society on December 6.The technique indirectly decompresses the neural foramen and stabilizes the cervical spine.
Medtronic, Inc.'s spine unit launched their latest addition to its cervical surgical technique portfolio, the CERVICAL FACETLIFTSM ID/S surgical technique, at the 40th annual meeting of the Cervical Spine Research Society on December 6.The technique indirectly decompresses the neural foramen and stabilizes the cervical spine.
A Federal Appeals Court panel has gutted the FDA’s prohibition of off-label marketing. The judges said the prohibition violates the First Amendment and prevents “intelligent and well-informed” decisions about medicine.
It's Christmas in County Cork as Stryker announces a new investment, new jobs AND a reversal of a previous plan to cut jobs. Nollaig Shona Dhuit.
It's Christmas in County Cork as Stryker announces a new investment, new jobs AND a reversal of a previous plan to cut jobs. Nollaig Shona Dhuit.
A battle of epic proportions for the opportunity to provide surgical services to patients who don’t require hospitalization is about to be played out in Colorado. Four physician-owned surgical centers are suing the state’s largest hospitals and insurers for conspiring to drive them out of business. See what we found.
Off-label promotion is protected free speech. So says a U.S. Appeals Court in New York. Pharmaceutical sales reps and manufacturers cannot be prosecuted for "speaking" truthfully about off-label use, ruled the Court. Does it hold true for device manufacturers and reps? See what we found out.
The FDA and LifeScience Alley have formed a consortium to smooth out and speed up the regulatory pathway process. If it succeeds, patients will have faster access to life-enhancing devices. Read about it here.
ISTO Technologies' NuQu cell-based biological therapy to treat lower back pain had no serious and unexpected safety concerns, showed promising treatment results and could eliminate a number of surgical spine procedures, according to a recent study.
ISTO Technologies' NuQu cell-based biological therapy to treat lower back pain had no serious and unexpected safety concerns, showed promising treatment results and could eliminate a number of surgical spine procedures, according to a recent study.
The president of the world's largest med tech association predicts a delay in the implementation of the device tax scheduled to take effect in January. He also tells investors on Wall Street what he expects from the FDA in 2013 and how Congress will avoid the "Fiscal Cliff."
The King is dead. Long live the King. In a surprising development, DePuySynthes Spine President, Namal Nawana resigned on November 27. Max Reinhardt, the company's top marketing executive will take over the top spot. Integration continues.
The U.S. Supreme Court is giving Jerry Falwell-founded Liberty University in Virginia another bite of the Obamacare apple. Did the law violate religious freedoms?
The FDA’s device section has an “empty bench” and can’t meet regulatory responsibilities. That’s the agency’s own assessment. With new money from industry and Congress, the FDA is reorganizing its device office to strengthen the bench. What’s the new organizational chart and what’s it mean for industry? Read it here.
Medtronic, Inc.'s latest quarterly results in spine could best be summed up by saying it was, well, a boring quarter.
Medtronic, Inc.'s latest quarterly results in spine could best be summed up by saying it was, well, a boring quarter.
Zimmer will soon be training regulators at their facility, "sharing knowledge and expertise in research, development, quality and regulation related to musculoskeletal health." That's a new kind of collaboration.
Zimmer will soon be training regulators at their facility, "sharing knowledge and expertise in research, development, quality and regulation related to musculoskeletal health." That's a new kind of collaboration.
The FDA's warning letter to Integra LifeSciences for the company's English facility offers some lessons about managing a quality control program. Read what the FDA said Integra did wrong.
A packaging issue has caused Synthes Trauma to recall every Trauma Fixation System sold in the U.S. since 2004. The company says there were no adverse events and is fixing the problem.
The new Congress will have another orthopedic surgeon, one less Pete Stark, lots of lawyers and an orthopedic leader in the Senate. See what we found out about the next Congress.
Orthofix launches the TrueLok Hexapod System for international markets at SIOT and SOFCOT in Rome and Paris. They're taking on the circular and hybrid fixation market leader.
For ten years the Freeman Health System in Joplin, Missouri paid their physicians based on the number of referrals for certain diagnostic testing and other services. After an internal audit, the system reported itself to the DOJ. On November 12, the government agreed to a $9.3 million settlement.
Tornier's CEO retired abruptly on November 12. The company's COO, David Mowry was immediately named as his replacement. Wall Street analysts were surprised and wondered what happened. Read what we found.
DePuy Orthopaedics is now offering the Trumatch Pin Guide for use with their Sigma Fixed Bearing Total Knee System. The guide recently received 510(k) clearance from the FDA.
DePuy Orthopaedics is now offering the Trumatch Pin Guide for use with their Sigma Fixed Bearing Total Knee System. The guide recently received 510(k) clearance from the FDA.
Orthopedic surgeons should be cheering the new Medicare physician payment plan for 2013. Congress willin’ and the “fiscal cliff” don’t rise, orthopedic surgeons have every opportunity to take advantage of new payment rules that reward keeping patients moving. Read what our payment experts had to say about the new rule.
David Floyd is taking over Stryker's Orthopedics and Spine Business. Tim Scannell gets MedSurg and Neurotechnology. Kevin Lobo has his team in place.
A GAO study says physicians increase imaging services after they gain ownership in those services. It allegedly cost taxpayers an extra $109 million in 2010. Read about the study here.
And then there were three… LDR announced on November 6 that the FDA has given the company an "Approvable Letter" for the firm's Mobi-C cervical disc. The Mobi-C joins Globus' Secure-C and NuVasive's PCM in receiving recent FDA cervical disc approvals.
And then there were three… LDR announced on November 6 that the FDA has given the company an "Approvable Letter" for the firm's Mobi-C cervical disc. The Mobi-C joins Globus' Secure-C and NuVasive's PCM in receiving recent FDA cervical disc approvals.
New Zealand's medical device regulator has noted an international hazard alert for Zimmer's metal-on-metal hip. Over 1, 000 lawsuits over DePuy's, Biomet's and Wright Medical's hips in the U.S. are moving into multidistrict litigation proceedings.
Globus Medical reported its first quarterly revenue numbers since going public. Sales rose 12.5% to $94.8 million for the third quarter. One analyst says the company has a solid list of new product launches that will help increase growth rates.
Lawsuits are starting to hit spine docs who injected patients with tainted steroids. Will the suits be about product liability or medical malpractice? Look at the billings, say lawyers.
Orthofix has executed a final $32 million settlement for whistleblower suits and government investigations stemming from its 2006 purchase of Blackstone Medical. All payments come from the escrow account set aside when Blackstone was purchased.
By virtue of being one of the last and largest orthopedic companies to report quarterly results, Zimmer Holdings, Inc.'s sales numbers give the clearest picture of where the market has been for the last quarter.
By virtue of being one of the last and largest orthopedic companies to report quarterly results, Zimmer Holdings, Inc.'s sales numbers give the clearest picture of where the market has been for the last quarter.
Celltex Therapeutics has agreed to abide by an FDA request to treat Texas Governor Rick Perry's stem cells as a drug and develop an Investigational New Drug submission. Perry says the FDA is wrong because the cells belong to him. The company will try to get the FDA to change its mind.
NuVasive Inc.'s PCM Cervical Disc System has joined Globus's Secure-C and Paradigm Spine's Coflex in receiving recent approvals from the FDA.
NuVasive Inc.'s PCM Cervical Disc System has joined Globus's Secure-C and Paradigm Spine's Coflex in receiving recent approvals from the FDA.
ISTO Technologies, Inc. is initiating a Phase II trial to further the efficacy and safety of its NuQu cell-based therapy for the treatment of pain and disability associated with degenerated spinal discs.
ISTO Technologies, Inc. is initiating a Phase II trial to further the efficacy and safety of its NuQu cell-based therapy for the treatment of pain and disability associated with degenerated spinal discs.
Spinal Restoration, Inc., developer of the Biostat System, has closed on a $5 million financing round to fund the company's Biologic License Application (BLA) submission and early commercialization efforts.
Wright Medical Technology wants providers who have products manufactured at its closed Toulon, France, facility to return them due a shelf life labeling issue. The company issued a voluntary Field Safety Correction Action in September for all products packaged at the facility which closed in 2007.
Medtronic is sending out a fleet of high-tech vehicles with access to every spinal technology available through the company.
Predictions of health care rationing, emergency room overcrowding and physician shortages under Obamacare are made by critics of the new law. Supporters say otherwise. What’s the nonpartisan view? ProCon.org dug in with a 128-page review of 62 questions about the law. We highlight three of great interest to orthopedic surgeons.
Kevin Lobo, Stryker Corporation's new president and CEO's first job was to lower expectations. Third quarter net sales of $2.1 billion, up only 1% from the previous year's quarter were, in Lobo's words, disappointing.
Kevin Lobo, Stryker Corporation's new president and CEO's first job was to lower expectations. Third quarter net sales of $2.1 billion, up only 1% from the previous year's quarter were, in Lobo's words, disappointing.
Johnson & Johnson's orthopedic franchise (formerly DePuy), excluding the impact of the Synthes acquisition in December 2011, grew sales by approximately 2.5% on an operational basis in the third quarter of 2012.
Johnson & Johnson's orthopedic franchise (formerly DePuy), excluding the impact of the Synthes acquisition in December 2011, grew sales by approximately 2.5% on an operational basis in the third quarter of 2012.
Brian McCollum, Orthofix's CFO, is taking over the company's Spine business. Bob Vaters, Orthofix's CEO says McCollum can take the business to the next level.
Wright Medical has ended the Deferred Prosecution Era by finally satisfying its obligations with the Justice Department. It was a tortuous road but the sun is shining.
On October 10, Wilmington, North Carolina-based TranS1 Inc. announced the signing of a distribution agreement with Beijing Jiade Sunshine.
The New York Times devoted precious space to a story about a tiny study in Canada and alleged intimidation of its principal investigator by the study’s sponsor. Vertos Medical, the sponsor, says no intimidation happened. This week, the researcher in question says that’s not true and hits back hard. Read the rest of the story here.
Biomet, Inc., often seen as the canary in the orthopedic coalmine, was first to report revenue for the last quarter. The privately-held company's results are closely watched by analysts to see where the broader orthopedic market is heading.
Biomet, Inc., often seen as the canary in the orthopedic coalmine, was first to report revenue for the last quarter. The privately-held company's results are closely watched by analysts to see where the broader orthopedic market is heading.
Stryker has launched a computer-assisted hip surgery system that can help surgeons to properly place lag screws in the femoral head. They say it's "revolutionary" and can help avoid revision surgeries. Read about it here.
Stryker has launched a computer-assisted hip surgery system that can help surgeons to properly place lag screws in the femoral head. They say it's "revolutionary" and can help avoid revision surgeries. Read about it here.
Jeff Rydin will be leaving his post as president of global sales for NuVasive, Inc. at the end of March 2013.
The FDA gathered its orthopedic panel to advise the agency about an industry petition to classify cervical pedicle and lateral mass screws as Class II devices. One panel member said they could have done this in 45 minutes after every major medical society testified in favor of the classification. Why was a panel meeting needed? Call it the “Ghost of Pedicle Screw Past.”
At least eight patients who received epidural steroid injections have died after they were infected with a fungal meningitis. The CDC says physicians should contact patients who had an injection using three lots of methylprednisolone acetate from the New England Compounding Center. Read the details here.
NuVasive had disappointing sales in the third quarter. Company leader Alex Lukianov said smaller companies were poaching his sales reps and PODS were taking business. He also said his surgeon customers are reporting new reimbursement push-back from insurers. Read what Lukianov had to tell analysts during a hastily convened conference call on October 3.
Stryker has a new boss. Kevin Lobo, who joined the company last year to run the new neuro and spine business and then quickly became head of orthopedics, was named to the posts of president and CEO.
The Supreme Court just started a new term. One of the first items of business? Giving the Obama administration and Liberty University 30 days to file responses to a previously dismissed challenge to Obamacare. What's up with that?
New York's Hospital of Special Surgery's former CEO has been arrested for an alleged kick-back scheme. The government claims John Reynolds took $1.4 million from hospital vendors, an employee and a British healthcare organization. Read about the allegations here.
Medtronic is paying over $800 million to buy Chinese orthopedic company, Kanghui Holdings. Who is Kanghui? What do they make and what are the implications for orthopedic competitors? Read what the analysts said.
Medtronic is paying over $800 million to buy Chinese orthopedic company, Kanghui Holdings. Who is Kanghui? What do they make and what are the implications for orthopedic competitors? Read what the analysts said.
In the midst of breast implant and metal-on-metal hip implant controversies, the European Commission unveiled a long awaited proposal to reboot Europe's medical device regulations. To see what is being proposed, read here.
In the midst of breast implant and metal-on-metal hip implant controversies, the European Commission unveiled a long awaited proposal to reboot Europe's medical device regulations. To see what is being proposed, read here.
Stryker has a new boss. Kevin Lobo, who joined the company last year to run the new neuro and spine business and then quickly became head of orthopedics, was named to the posts of president and CEO on October 1. Curt Hartman, the company's CFO and interim CEO since Stephen MacMillan's departure in February, will stay on temporarily to advise Lobo, and then depart the company.
Stryker Corp issued an "Urgent" recall of the Neptune Rover Waste Management System in June after a fatality was reported. Three months later the recall was expanded because the FDA told Stryker the devices weren't cleared for sale. The company didn't comment on clearance issue.
After learning the ropes at Stryker Orthopaedics and Medtronic, Stephanie Fitts, Ph.D. has taken over regulatory, quality and compliance responsibilities at TranS1, Inc.
Mitt Romney and Republicans have promised to repeal Obamacare if voters give them the chance in November. What will health care reform look like after the elections if they win? Read what health care marketplace expert Robert Laszewski says you need to know.
Two of the painkilling drugs used by orthopedic patients are being recalled. Two lots of Hydrocodone Bitartrate and APAP Tablets have been voluntarily recalled by Watson Laboratories
A group of physicians in Miami who invested in an orthopedic company to market screws, plates and implants are suing after their stock, according to the Miami Herald, plummeted from $2.58 to a penny a share in less than a year. Read what's happening at Internal Fixation Systems.
Want to offer your patients rapid pain relief from metastatic spinal tumors in a single, minimally invasive treatment? DFINE, Inc. has just released a system they claim does just that. Read about it here. .
Lanx, Inc.'s Aspen MIS Fusion System has demonstrated a 94% fusion rate, according to new clinical data from a study announced by the company.
Lanx, Inc.'s Aspen MIS Fusion System has demonstrated a 94% fusion rate, according to new clinical data from a study announced by the company.
Kids with idiopathic scoliosis have a newly cleared deformity spinal system on their side. The FDA just cleared the additional use of K2M's MESA system. Read about the system here.
Kids with idiopathic scoliosis have a newly cleared deformity spinal system on their side. The FDA just cleared the additional use of K2M's MESA system. Read about the system here.
How did a 10-patient study at the University of Saskatchewan end up in The New York Times? And how did the company involved find itself at ground-zero of controversies of industry influence in research and a highly criticized FDA clearance program? We dug in.
When scientists at the FDA disagree over science, applications can be scuttled, whistleblowers arise and heads can roll. The FDA has announced new procedures to avoid internal food fights. Read them here.
Establish a UDI system, promote registries, modernize adverse event reporting and develop new methods of evidence generation, are four changes the FDA wants to make to its postmarket surveillance system. Read details here.
An appeals court has overturned Neurovision's $60 million victory over NuVasive over the use of the NEUROVISION trademark. They replaced the trial judge and sent the case back for another trial.
New Jersey's Horizon Healthcare Services has agreed to provide coverage for Kimberly-Clark's SIngery Cooled Radiofrequency System. See what one study says about the procedure to treat sacroiliac joint pain.
Five years after the government forced industry and surgeons to redefine their relationship, orthopedic surgeons have come out with their own manifesto for managing those relationships. How did we get here and what’s the manifesto say? Read it here.
A federal judge in Boston has rejected a plea agreement between Orthofix and the Justice Department to resolve a bone growth stimulation criminal investigation. The company remains confident the matter will be resolved amicably.
K2M, Inc., has launched a retractor system that company President and CEO Eric Major says, addresses complex pathologies within a less invasive environment.
LDR has received FDA clearance for the first lateral lumbar cage with integrated in-line plating to be marketed in the U.S. See what the company had to say about it.
Medtronic Chairman and CEO Omar Ishrak keeps saying globalization is a key driver for growth for the company. On August 27, the company announced the opening of an Innovation Center at its headquarters in Shanghai, China. The company expects to hire 1000 skilled staff over the next five years in China with hundreds at the Innovation Center.
The FDA is holding a public meeting on September 10, 2012 to solicit public feedback regarding the agency's soon to be released proposal to strengthen the medical device postmarket surveillance system. Better not miss this one.
Medtronic, apparently isn't done suing NuVasive over intellectual property. On August 23, NuVasive disclosed that Medtronic is suing them again. This time over NuVasive's Osteocel Plus bone graft and its CoRoent XL family of spinal implants.
Sheryl Conley is replacing David Floyd as head of OrthoWorx in Warsaw, Indiana. Floyd wants to return to industry and Conley wants to pursue the Orthopedic Capital Clinic.
Over a three year period, the government says former ArthroCare Corporation senior executives John Raffle and David Applegate inflated publicly reported revenues through fraudulent sales to DiscoCare. On August 22, the federales swooped in and arrested the pair. We’ve got all the allegations about DiscoCare and SpineWands right here.
Medtronic, Inc. reported a $4 billion dollar quarter on August 21, 2012. That's up 2% on a reported basis over last year. Analysts credited strong coronary stent sales as a major contributor to the overall sales gain.
Medtronic, Inc. reported a $4 billion dollar quarter on August 21, 2012. That's up 2% on a reported basis over last year. Analysts credited strong coronary stent sales as a major contributor to the overall sales gain.
Looking to continue to become the top extremities franchise in the word, Tornier N.V. announced on August 24, 2012 that it was acquiring OrthoHelix Surgical Designs, Inc. for $135 million.
When industry agreed to double user fees, the FDA promised to speed up application review times. The agency is proposing a new checklist to pre-assess submissions. You have until September 27 to comment. Read the details here.
The Blackstone Whistleblower lawsuit unsealed in Florida on August 8 has been dismissed. Orthofix and the former owners of Blackstone have also resolved all escrow claims from the 2006 sale of Blackstone to Orthofix.
A hemostatic bone putty made by Synthes, USA, Inc is being recalled because there is a potential for the putty to ignite if contacted with electrosurgical cautery systems during surgery.
A federal judge says manipulating stem cells and reinserting them into patients makes them a drug. Not so, say a former FDA deputy commissioner and many physicians. The procedure is simply a practice of medicine and the FDA has no authority to regulate the practice. Who is right? Will stem cell therapies go overseas? Decide for yourself.
Marcy Rogers, M.Ed. is back and SpineMark Corporation is alive. It was announced on August 15, 2012 that SpineMark and Rogers have formed a partnership with PhDx Systems, Inc. and Millenium Environmental.
K2M, Inc. has a new neuromonitoring system for the company's Ravine Lateral Access System.
Lanx, Inc. has been granted a patent by the U.S. Patent and Trademark Office for the company's Aspen MIS Fusion System technology. The company touts that the technology requires smaller incisions, less muscle trauma, less blood loss and shorter surgery and recovery time than standard pedicle screw instrumentation.
Lanx, Inc. has been granted a patent by the U.S. Patent and Trademark Office for the company's Aspen MIS Fusion System technology. The company touts that the technology requires smaller incisions, less muscle trauma, less blood loss and shorter surgery and recovery time than standard pedicle screw instrumentation.
Biomet Spine says it has a new screw technology that will have the same "game changing" impact on screw placement as the advent of the multi-axial screw.
Biomet Spine says it has a new screw technology that will have the same "game changing" impact on screw placement as the advent of the multi-axial screw.
With the specter of draconian cuts mandated for Medicare and physician reimbursements in January 2013, Medicare comes out and increases orthopedic and spine related procedure reimbursements by over 4%. What’s this mean for surgeons, hospitals and device companies? Read it here.
Medicare has a new high-tech fraud war room. The agency opened the $3.6 million command center in a commercial office park in Baltimore at the end of July.
The FDA's Orthopaedic and Rehabilitation Devices Panel is meeting on September 21, 2012 to discuss and make recommendations about classification of posterior cervical screws.
The first head-to-head retrospective comparison of AxiaLIF to the traditional ALIF procedure showed statistically similar fusion rates. But, interestingly, the AxiaLIF procedure had fewer adverse events. See what the TranS1 study showed.
Just when it seems Wright Medical has put their legal problems behind them, the DOJ pulls them over again and issues the company a subpoena covering 12 years of records related to the company's Profemur hip device.
Zimmer Holdings, Inc. and Genzyme Corp have been in a Boston federal court for the last year fighting over the patent for hyaluronic acid injection treatments for arthritic knees. On August 3, 2012, a jury ruled in Zimmer’s favor by declaring Genzyme's patent invalid.
Zimmer Holdings, Inc. and Genzyme Corp have been in a Boston federal court for the last year fighting over the patent for hyaluronic acid injection treatments for arthritic knees. On August 3, 2012, a jury ruled in Zimmer’s favor by declaring Genzyme's patent invalid.
Wright Medical Group, Inc. reported $123.3 million in revenue for the second quarter. While that number was down 5% on a constant currency basis over the previous year's quarter, the underlying story is all about the company's plan to turn around a business that has been beset with regulatory and sales problems.
Wright Medical Group, Inc. reported $123.3 million in revenue for the second quarter. While that number was down 5% on a constant currency basis over the previous year's quarter, the underlying story is all about the company's plan to turn around a business that has been beset with regulatory and sales problems.
Now that second quarter orthopedic sales results are in, we thought we’d bring you the second quarter Premarket Approvals (PMA) Original and Supplemental Approvals from the FDA.
DePuy Synthes Spine has made its first official FDA 510(k) clearance announcement. The FDA has given clearance for the use of the company's Expedium, Viper, and Viper2 Spine Systems on patients with adolescent idiopathic scoliosis.
The news from Orthofix International NV over the last month has been mostly about legal settlements as the company cleans up problems related to marketing activities under previous leadership.
A government body charged with keeping some of the most sensitive secrets in science and medicine began to spy on its own employees to see who they were talking to and what they said. Is this East Germany in the 1960s? Nope, it’s the FDA in 2009. Read the sordid details here.
NuVasive, Inc.'s 2012 second quarter revenue of $154.4 million was up 16.1% on a reported basis from the previous year. The company also reported a profit of $2.9 million on a GAAP basis.
Weaker than anticipated reconstructive sales brought Zimmer Holdings Inc.’s reported sales down by 1.1% during the second quarter of 2012. Sales increased 1.8% on a constant currency (cc) basis.
The Orthopedic Capital of the World got just a little bigger last week when Iconacy Orthopedic Implants LLC received a $162, 763 tax abatement to open for business in Warsaw, Indiana
Michael Cobb, the Rhode Island physician's assistant who took kickbacks from former Orthofix Inc. managers between 2004 and 2011, has been sentenced to jail. On July 19, U.S. District Judge George A. O’Toole sentenced Cobb to one year incarceration (six months in prison, six months home confinement), to be followed by two years of supervised release and a $3, 000 fine.
EMERGE Medical launched another torpedo in the battle over generic medical devices when a new deal to distribute their products to Cardinal Health's 60, 000 locations was announced on July 18. In March EMERGE signed a deal with Premier, the second largest healthcare GPO in America.
The Association for Medical Ethics is Charles Rosen, M.D.’s platform for misleading and biased pontificating. Dr. Rosen sits on the editorial board of a non-peer reviewed journal. An article in the journal say physicians in PODs can’t be trusted. The physicians from the American Association of Surgeon Distributors hit back. It was an unfair fight. See what we mean.
The rise in the rate of retractions in scientific journals is due to the reality of the need to publish or perish and the existence of “grandiosity, perfectionism, and sociopathy” in the scientific community. Those are the findings in a recent study published in Academic Medicine and reported by our friends at Retraction Watch.
A disappointing second quarter and lowered expectations hammered MAKO Surgical's stock and resulted in the resignation of the company's sales leader. Company founder, Maurice R. Ferré, M.D., keeps the faith and vows to improve execution. Read the numbers here.
As the third orthopedic company to report revenue for the second quarter, (after DePuy Synthes Companies and Biomet, Inc.), we are beginning to see a clearer picture of the overall orthopedic market.
The FDA is in hot water with Congress over an email surveillance program targeted at scientists who were complaining about review procedures. The episode raises questions over privacy and retaliation.
The FDA needs your suggestions. The agency has proposed a new "Pre-Submission" program that would allow industry to ask questions about regulatory requirements during product development and early protocol planning. This could lower regulatory hurdles, so we recommend you offer your suggestions.
A “White Coat of Silence” makes it hard for well qualified doctors to testify against negligent colleagues. So says the orthopedic surgeon who successfully sued AAOS when his membership was suspended after providing expert testimony against another AAOS member in a medical negligence trial.
OTW has learned that the North American Spine Society has undertaken an internal review of the process leading up to the publication of the controversial June 2011 Spine Journal edition accusing InFuse researchers of financial bias. We asked NASS for confirmation. Read what we found.
Spinal Restoration has completed enrollment of its clinical study of the Biostat System. The company hopes the study shows the system's fibrin sealant, featured on CBS's Sunday Morning in May, can help people with lower back pain attributable to disruption of the internal structure within the intervertebral disc.
The President signed the new device user fee law on July 9. For $609 million over the next five years, industry has been promised a better and faster medical device review process. Let the tracking begin.
Stryker's voluntary recall of its modular-neck hip stems in July 6 is causing some to wonder if the FDA has another hip controversy on its hands. See what the recall is about and what it might mean for other hip makers. Don't know about patients yet.
With 6, 000 lawsuits and counting, experts from around the world, every major orthopedic society, an unprecedented FDA panel and patients with failed hip implants. Recipe for change? Hardly. In fact, from a market standpoint, this FDA meeting may have been irrelevant. Here’s why.
A Japanese anesthesiologist has set a new record for retractions, according to our friends at Retraction Watch. Overall, retractions in scientific journals are up. What’s going on? Is science getting less honest? Read it here.
A group of Tunisian researchers have been accused, for a second time, of plagiarism. Now the Indian Journal of Dermatology has imposed a lifetime ban on the authors. Is a publishing “death sentence” appropriate? See what Retraction Watch reported and what the Committee on Publication Ethics (COPE) has to say about bans.
The House repealed the 2.3% medical device tax on June 7. Senate leaders said it was DOA in the Senate and the White House said the President would veto the bill. But, Democratic Senators from medical device manufacturing states want to dump the tax. Read what our political and markets experts say about its chances.
First The Wall Street Journal reported that the former Stryker Corporation CEO was gunning for a job with his old employer, Johnson & Johnson. It is reported that with the DePuySynthes merger completed and rumors of Steve MacMillan "looking like a good fit" to run the new ortho business, would his two-year non-compete agreement with Stryker stand in the way?
After profiling Dr. Kaul’s humanitarian work in the Congo, we heard from our readers about his troubles in New Jersey. After investigating further, we realized that there was much more to Dr. Kaul than we realized. And it was deeply concerning. Here, then, is the rest of the story.
When a researcher lies about getting IRB approval, his papers will be retracted. But what if the research evidence still has value? That’s the dilemma behind this week’s “Retraction of the Week” from the journal Circulation of four papers by Hideaki Senazki, M.D. Let us know what you think.
PODs stifle innovation and cost the healthcare system money in the long run, says Pat Miles of NuVasive. Not so says John Steinmann, M.D. founder of the first POD. They save the system money by removing “obscene” profit margins. Who wins and loses when physicians own their own means of distribution? You decide.
It doesn’t take industry funding to trigger biased research—as we learned with Carragee’s The Spine Journal BMP issue. Bias is abundantly prevalent among scientists with NO industry ties. To illustrate this, we present a new weekly feature: The Scientific Journal Retraction of the Week. Let us know what you think.
The New England Journal of Medicine is celebrating its 200th birthday by taking a fascinating look back to a truly unimaginable time. We’ve surely come a very long way. Does the past have lessons for today? It does. After all, those who ignore the past are doomed to repeat it.
The Blues of Illinois say there is a lack of evidence to justify spinal fusion for DDD and other indications. Spine’s best minds fire back in this OTW exclusive story by accusing the insurer of shoddy literature work and using unscientific guidelines. Read it here.
Ortho sales tanked in the aftermath of The Great Recession. But 2012 is a new year. First Quarter sales reports from the “big five” were generally better than expected. Who won the sales competition for hips, knees and extremities for the quarter? Read it here.
Between 1950 and 2009, health care spending as a percent of U.S. GDP quadrupled. Those dollars paid for a Golden Age of Medicine. In the current era of fiscal conservancy could this Golden Age of innovation and science be at risk? A recent NEJM article tackled this very question. Here’s what they said.
Synthes, Inc. is suing John Marotta, a former employee who makes and sells generic implants, for breach of contract. Marotta and his firm, Emerge Medical, Inc., are countersuing, accusing Synthes of trying to create a monopoly. What’s at stake? We find out.
Is LDR going public? The company just hired Bob McNamara as the new CFO. McNamara has "extensive" experience with Initial Public Offerings, according to a company announcement.
A phony consulting agreement, laundered pay-offs, backdated time sheets and a cast of characters named DZ, RM, JM, Dr. P and Dr. S, star in the latest federal prosecution of medical device reps and, allegedly, docs gone bad. Read the details here.
Biomet made an unexpected $280 million bid to acquire DePuy Orthopaedics' trauma business. Our Publisher Robin Young was quoted in Ft. Wayne’s Journal Gazette saying that Biomet should show profits before going shopping. Why a surprise? Read here.
Are Physician-Owned Distributorships legal, ethical and do they reduce overutilization? Bill Kolter of Biomet and Dr. John Steinmann, founder of the first POD; square off in a very interesting and highly informative debate this week. Who wins? You be the judge.
The British Hip Society issued a warning against large diameter metal-on-metal hip implants. Will their American colleagues heed the warning? AAOS, FDA, hip device manufacturers and Wall Street all weigh in on the unusual British action.
Dave Dvorak has been named the new Chair of AdvaMed. The job was supposed to go to Steve MacMillan, who had to bail out after losing his AdvaMed board seat when he left Stryker. Dvorak cleaned up Zimmer and now he's picking up after MacMillan. He's the new leader of all medical device makers.
Blue Cross Blue Shield of Minnesota announced recently that it will not pay for ANY part of a surgery if BMPs are used off-label. Dangerous precedent? After inquiries from OTW, the insurer started to back down saying it will consider “immediate revisions” to the policy. But was BCBS trying to practice medicine?
Stryker Corporation and Stephen MacMillan have agreed to a separation agreement worth millions. He gets severance pay, stock options, extended medical benefits, office space and outplacement services.
Wright Medical Technology, Inc. is King of the Foot and Ankle Hill. A recent survey by PearlDiver Technologies, Inc. shows that surgeons view Wright Medical, followed closely by Arthrex, Inc. as the most favorable suppliers for their specialty. Read what the PearlDiver data uncovered.
John Tongue, M.D., the new AAOS president, says elected officials are not telling the truth about the need to limit benefits (rationing) to broaden access to healthcare for everyone. He had no such problem at the recent AAOS meeting. Read why he says orthopedics can win when rationing comes.
Three wrongful termination lawsuits offer an unprecedented look inside the company’s DPA troubles. Last week OTW looked at allegations against the Wright Board. This week we look at the specific complaints about Wright’s compliance program. Fasten your seatbelts. It ain’t pretty.
Stephen MacMillan, the dean of orthopedic executives, has resigned immediately as Chairman, President and CEO of Stryker Corporation.
Three former employees terminated by Wright Medical in the middle of the company’s monitoring program with the feds have filed lawsuits against Wright Medical claiming they were terminated for reporting compliance problems to the Board. OTW read the complaints. Here’s what we found.
Stryker’s MacMillan and JNJ’s Weldon both pointed to the world’s aging population as a major factor which could pull orthopedics out of the Great Recession. How might that happen? Hear what they told analysts.
Wright Medical Group, Inc. has induced Daniel Garen to take over the organization's beleaguered compliance program and immediately become Senior Vice President and Chief Compliance Officer of the company.
In 2008, the U.S. Healthcare system and the Medtech industry caught the “discretionary spending flu.” Four years later, how’s the patient doing? BMO Analyst Joanne Wuensch has diagnosed the patient and gives her prognosis. Conclusion; there is still some coughing, but the patient is getting out of bed.
Dan Webber has been promoted to lead Pioneer Surgical. The company's CFO is now also president and CEO.
What happens when two of the largest orthopedic company’s merge? If it’s San Francisco and if it’s DePuy buying Synthes then the answer is sales reps jumping to greener pastures. The inevitable lawsuit was filed three days after Christmas. Bottom line; Synthes is shocked! Shocked! Details here.
Which stories were the most read on the pages of OTW in 2011? The birth of an orthopedic superpower, the death of a young engineer, dangerous accusations of clinical bias, disruptions, mutiny and the reflections of an inventive genius made the list. See which stories our readers picked.
The FDA endured a lot of criticism in 2011. The agency was accused of stifling innovation and driving entrepreneurs overseas. The agency responded with a plan of action to improve performance and, in December, entered into a novel collaboration with industry. Read about their agreement with Minnesota’s LifeScience Alley.
Former Medtronic and AGA executive Don O'Hearn to lead K2M sales in the Americas.
The orthopedics device and provider community experienced a "Mediscare" on Friday, December 2. News swept through Wall Street’s trading desks that Medicare was going to require 100% pre-authorization for a range of orthopedic procedures. See what happened and find out what it means for surgeons.
Physicians have been the target of antitrust prosecutions by the Justice Department and the Federal Trade Commission for years. Now the government wants to hear from physicians about potential antitrust market practices by hospitals and insurers in their communities. Read what the lawyers want you to look for.
Marilyn Tavenner is taking over as Administrator of the Centers for Medicare and Medicaid Services (CMS).
Can bundled payments reign in rising health care spending including surgeon payments? New study sheds light on where cost savings in hip and back care might lie. Guess what? It’s not with the surgeon.
“Who are we to believe, ” was on the minds of physicians as they attended the Annual Meeting of North American Spine Society in Chicago. Past presidents and a former editor of The Spine Journal give us their take on the current state of the Society and whether or not the Society’s ethics agenda has pitted member against member.
A recent study found discrepancies and a general lack of transparency in spine fusion payment policies. Some payer policies, for example, are based on guidelines that are not even publicly available for review. Read what the spine experts told OTW about the study.
Medtronic side stepped a direct confrontation with Eugene Carragee, M.D., and The Spine Journal over allegations of “biased and corrupted” Infuse research. But a lawsuit filed in Florida against Medtronic citing Carragee may set up a confrontation in a courtroom. Read what English v Medtronic is all about.
Gary Moore died at St. Dominic's Hospital in Jackson, Mississippi on April 7, 2011. The Wall Street Journal says it is partly due to the surgeon’s ownership in a medical device company. But the facts don’t match the accusation. It’s another bungled, misleading story from WSJ. We set the record straight.
Bryan McMillan is the new head of a reorganized Orthofix spine business.
Columbia University used the wrong data to conclude that fees paid U.S. orthopedic surgeons to perform hip surgery is a “main driver” of higher health care spending in the U.S. AAOS and PearlDiver found the right numbers and here they are. In fact, U.S. surgeons are paid less than many EU surgeons.
After a tumultuous spring and summer, Wright Medical enters the fall with a plan to restructure, settle their fight with the feds, hire a new leader, and get back to business. It’s been a heck of a ride. So where does Wright stand now?
Will the 2.3% medical device tax squeeze the neck of the orthopedic goose laying golden eggs? Or will it prime the pump so that more patients have coverage and money to pay for orthopedic procedures. AdvaMed’s new study argues the former. Read the argument here.
Mike Mahoney is leaving Johnson & Johnson (J&J) to replace Ray Elliott as president and CEO of Boston Scientific Corp.
There’s more action than ever at the FDA. What are the top ten regulatory initiatives at the FDA that should keep you awake at night? Ralph Hall, the well known law professor and FDA critic, tells us. Read it here.
David Floyd has a new job – keeping Warsaw, Indiana as the "Orthopedic Capital of the World, " as the first CEO of OrthoWorx.
After a year of anemic international sales growth, Stryker Corporation has replaced its Group President, International. Ramesh Subrahmanian, Merck's former leader in the Asia Pacific region, will take over for Andrew Fox on September 1.
Omar Ishrak, the new CEO of Medtronic, didn’t mince words in his debut with Wall Street analysts about mistakes made by previous leaders. He laid it bare and described his vision. By the end of the day, the value of the company had risen $2 billion. What did he say?
The 20-year united physician front on advising Medicare on relative medical procedure values is cracking as the provider slice of pie of the federal budget shrinks. See what’s driving primary care physicians threats to blow up the whole AMA/CMS payment system.
Six Georgia physicians are suing CMS. Their complaint? Medicare is illegally setting physician fees in cahoots with the AMA. This lawsuit is tackling physician service values and payment schedules. What’s a physician’s service worth? Is the Physician Fee Schedule unconstitutional? Here’s what we found in this first of a two-part story.
A 2% cut to federal spending over the next decade required in the debt ceiling legislation includes Medicare. Combine that with a mandated 29.5% cut to physician fees by year’s end, and there will be blood on the floor. Who’s blood? Read it here.
One of the most famous and commercially successful orthopedic surgeons of his generation speaks out about the current state of the relationship between industry and surgeons. Trust us; Gary Michelson, M.D. does not pull punches.
Spine companies and surgeons are lining up to meet the latest insurer challenge to certain fusion procedures. Blue Cross Blue Shield of Minnesota wants to exclude ALIF, AxiaLIF, XLIF and DLIF procedures from coverage. We’ve seen this story before. Read what the players have to say.
The FDA's top device regulator, Jeff Shuren, M.D., has a new boss. Former Dartmouth Medical School Dean Stephen P. Spielberg, M.D. has been named to a newly created FDA position of deputy commissioner for medical products and tobacco.
In February 2009 an anonymous blogger by the name of Musculoskeletal Man began scorching surgeons for being greedy and spine companies for producing “me too” products. We’ve been asked if we know his identity. We just might.
Gary Michelson, M.D., won the largest patent award in history. His inventions for spine surgery allowed surgeons with ordinary skills to get the same results as high skilled surgeon. We revisit an OTW interview with the retired surgeon and see what he’d done with his money.
Christophe Lavigne, the cofounder, president and CEO of Austin, Texas-based LDR, has been named a 2011 Ernst & Young Entrepreneur of the Year award winner for the Central Texas Region.
The entire landscape for proving a “false claim” for Medicare reimbursement has been altered as a Boston appeals court reinstates Susan Hutcheson’s whistleblower lawsuit against Blackstone Medical. How are they related?
Indiana-based DePuy Orthopaedics, Inc. has promoted Andrew Ekdahl to be its new president. He replaces David Floyd, who left the company at the end of March.
A bipartisan group of U.S. Senators want the Office of Inspector General to investigate the growth of Physician-Owned Distributorships and let them know if federal legislation is needed to keep them legal and ethical. Some POD owners agree. Read what the Senators found in their own investigation.
Usually personal injury lawyers sue device companies on behalf of clients. This time, “Man Bites Dog, ” as Zimmer sues lawyers fishing for clients by making false claims about the NexGen Knee System. Zimmer bit back and forced retractions. Read what it was all about.
Olympus Biotech, formed in 2010 after acquiring OP-1 from Stryker, has named Oliver Burckhardt as president.
Biologics for ankle fusion got a shot in the arm when the FDA’s Orthopedic Panel voted to recommend approval for BioMimetic’s Augment. It wasn’t pretty. It was dramatic, close and contentious. We were there when CEO and founder Lynch made his “Hail Mary” pitch.
At a time of industry consolidation, Medtronic reaches into GE Healthcare to pluck out a new chairman and CEO for itself. Omar Ishrak, Ph.D., was named to the Medtronic post on May 11. Will he join in on the industry consolidation momentum?
When the watering hole shrinks, all the animals begin to look at each other differently. That may be a perfect metaphor to describe how various medical societies are approaching the next version of the “Doc Fix.” See what they told Congress recently.
The Wall Street Journal’s claim that a California physician-owned distributorship (POD) paid surgeons to use products, has claimed its first victim—Omega Solutions. Two law firm giants on opposite sides of the POD argument weigh in with their arguments. Read it here.
On April 27, Stryker announced who will lead the company's new Neurotechnology and Spine Group. It's Kevin Lobo, the former head of Johnson & Johnson's Ethicon-Endo Surgery business.
Physicians are in danger of becoming “medical sharecroppers” on the “ACO Plantation” if they don’t organize and petition the government. That’s the message from a former hospital lawyer. As May Day approaches, physicians have never been more in need of collective action.
On March 21, 2010, a large number of Stryker managers and sales reps in Arizona and Las Vegas resigned to take jobs with Zimmer Spine. Stryker immediately filed a lawsuit against Zimmer and their former employees and accuses Zimmer of corporate raiding. We’ve got the details.
Susan Alpert, M.D., Ph.D., a former director of the FDA's Office of Device Evaluation and, since 2005, the Senior Vice President and Chief Regulatory Officer at Medtronic, Inc. is retiring at the end of April.
Curtis Dickman, M.D., said fellow Phoenix surgeon Tony Yeung, M.D., was a “danger to the public.” Yeung sued him. Their fight is bouncing around the courts and offers important lessons for any physician considering filing a complaint against a colleague. Read the details of the legal battle here.
Vicente Trelles is joining his former partner Bob Vaters at Orthofix in the newly created position of Senior Vice President, World Wide Operations and Shared Services.
Nine former employees of Smith & Nephew’s Visionaire team in Memphis are being sued by the company for conspiring to take company secrets and start their own business. A former colleague blew the whistle on them. See what the Complaint and Affidavits have to say.
The U.S. Senate has passed major patent reform legislation to move America from a “first-to-invent” to a “first-to-file” system. It must still pass the House. What’s this mean to the orthopedic inventor “tinkerer?” Will there be race to patent office? Read what a patent lawyer told OTW.
Nawal Nawana, a 13-year Johnson & Johnson veteran, has been named the new President of the DePuy's spine franchise. He replaces Gary Faschetti, who was recently promoted to DePuy Group Chairman.
Profound economic changes for orthopedic surgeons and vendors were on display at the February 2011 AAOS Annual Meeting in San Diego. Surgeons wanted to know who will represent their best interest in the post reform era. See what Dan Berry, M.D., the new AAOS president told us.
Jim St. John is the new Vice President International Sales at Pioneer Surgical. He has lived in Europe for over 12 years, speaks 5 languages and has 25 years of experience in the spine industry.
Anulex received a warning from the FDA on February 11 for the alleged off-label promotion of Xclose, the company’s 510(k) cleared anulus tissue repair device. Did the agency over-reach or did the company over-sell?
David Floyd is leaving DePuy Orthopaedics to pursue interests outside of DePuy and Johnson & Johnson. Having grown up in Warsaw, Indiana, the orthopedic capital of the world, those interests will undoubtedly be many and centered on his family.
The Obama Administration unveiled its proposed 2012 healthcare federal budget on Valentine’s Day with a two-year “Doc Fix” for physicians. OTW looks under the hood of the proposal and reports on the opportunities and challenges for the orthopedic community.
The FDA wants to set up a priority review program to get innovate and promising medical devices to patients quicker. But what are those technologies and devices? A new report tells us.
An increasing number of spine surgeons are having fusion procedures denied by insurers. The reason cited by the insurers? The Milliman Care Guidelines. Who and what is Milliman? OTW digs in.
Centinel Spine, Inc. expanded the company's sales team at the end of January by hiring Bill Pfost and Dan Martin, as the new National VP of Sales and Area VP of Sales, respectively.
Medical device developers have repeatedly warned that an outdated regulatory scheme was stifling innovation in America, depriving patients of cutting-edge medical technology and pushing jobs overseas. On January 19, the FDA responded. What are these changes and will they work?
Hallett Mathews, M.D., MBA, has left Medtronic Spine and Biologics to join the Viscogliosi Brothers as President of VB Professional Services.
Reforming payments to physicians is seen by many as the best way to improve quality and control costs. Healthcare economist Paul Ginsburg, Ph.D., lays out how the new healthcare law tries to get us there and how there will be winners and losers in the physician community.
Bob Vaters has been recognized and promoted for his good work at Orthofix International.
From Haiti to healthcare reform to the farewell of the independent surgeon and defining medical necessity, 2010 was a remarkably eventful year. AAOS and OTW look back.
Ken Reali has been named TranS1's new CEO. Outgoing CEO, Rick Randall becomes the Executive Chairman of the Board of Directors.
While federal judges issue highly publicized different rulings on “ObamaCare, ” physicians are also waiting to hear if a provision limiting their ownership in hospitals violates their right to due process and equal access of the law. Read how the cases all fit together.
Dan Gladney is Lanx, Inc.'s new leader. Has the company finally put its CEO house in order?
Joe Ross is the new Vice President of U.S. Marketing at LDR Spine. He joins LDR during a time of growth and new product launches.
Nine societies put up a united front in the face of North Carolina's Blue Cross/Blue Shield’s proposed change in lumbar fusion reimbursement policy. Can this united front bring reason and clinical relevance to Blue Cross/Blue Shield? See what nine societies said.
A proposal by a North Carolina insurer to stop paying for certain types of fusion surgeries has prompted some spine surgeons to call for drawing a line in the sand before other states follow suit. Read what’s behind the politics of the spine community’s response.
Are Americans suffering from a “Device Gap” due to unreasonable regulatory requirements? Do Europeans do it better? A new study says yes and we better act before we lose our Golden Medical Device Industry Goose.
Could the next few years be a period of "creative destruction, " as this fragmented fee-for-service system morphs into a more coordinated system of care? The answer is yes and the reason is A-C-O. Who will control ACOs—physicians or hospitals?
The fate of what some call “Obamacare” will be decided by numbers. The 2010 election changed the math in Congress, Governor’s Offices and Statehouses. See what our experts say is the most likely fate of “Obamacare” and what lies ahead in 2012.
The Veterans Administration has bestowed its highest science honor on University of California-Irvine orthopedic surgeon, Thay Q. Lee, M.D. The U.S. Department of Veterans Affairs (VA) announced the appointment of Lee as a senior career scientist.
NuVasive’s sales grew 27% in the third quarter but lowered guidance for the future. Why? Insurer pushback may cause the spine market to contract by 10 to 20%. Company CEO Alexis Lukianov said the industry is at a tipping point. Read what he told analysts.
Biomet founder, Dane Miller, Ph.D., was named the August M. Watanabe Life Sciences Champion of the Year at this year's seventh annual Indiana Life Sciences Summit in Indianapolis.
Can Jeff Shuren, M.D., the FDA’s top device regulator “part the clouds” hanging over the most expensive 510(k) process in history? Will his intention to rescind ReGen Biologic’s clearance result in another regulatory pathway for the device deemed safe by two FDA panels? Read it here.
The absence of Synthes from NASS’s 25th birthday party was an indication of the times and state of Spine. What does Synthes’ decision tell us about the evolving relationship between industry and spine care providers and what does it mean for the future of NASS?
Do AAOS and NASS disagree over the evidence of the effectiveness of vertebro- and kyphoplasty? AAOS issued new clinical guidelines for the procedures that don’t match NASS’s guidelines. Where does the truth lie and is there new evidence on the horizon?
There was little controversy at a MEDCAC meeting over the quality of evidence involving the benefits and harms of BMPs. However this marked the first time the committee considered cost effectiveness. Read what the committee and tech assessment had to say about the price of pain.
The rising influence of hospitals in making purchasing decisions about medical devices is a result of a confluence of changing market forces, healthcare reform and a tougher regulatory environment. The consequence is the waning influence of the surgeon. What’s it mean for device makers?
Jeff Shuren, M.D., the FDA’s top device regulator, has improved his bench by appointing cardiologist Bill Maisel, M.D., to head up a new Science Council within the agency. Get to know Maisel and what the new Council will do here.
Medtronic lost 4.7% of market share in spine this last quarter. Revenue declined over 9%. What happened? The company’s CEO Bill Hawkins acknowledged the pain and said people won’t defer procedures forever and Medtronic will be back. How will they do it? Read here.
FDA recommendations to retool the 510(k) program will likely add to industry’s burden to bring innovative products to market. In Part Two of our three part series, law professor Ralph Hall and AAOS member Bill Mihalko, M.D., give their opinions on what these recommendations will mean for industry and physicians.
The FDA’s 510(k) clearance program has been 99.78% successful in keeping unsafe products from reaching the public. On August 3, the agency released 70 recommendations to retool the program. If the program works, why does it need an overhaul? Read the first of our three-part series.
Orthopedics now has a seat at the highest level of national manufacturing policymaking. Stryker's Steven MacMillan has been named to the 2010 federal Manufacturing Council by U.S. Secretary of Commerce Gary Locke.
CMS’s Coverage Advisory Committee will meet on September 22 to consider and vote on the on- and off-label evidence for paying for BMPs. Read what Steve Phurrough, M.D., the former coverage director at CMS, predicts will happen.
Depending on your political views, Donald Berwick, M.D., the new head of CMS, is either a medical socialist or thoughtful quality guru who will help fix an out of control federal health care budget. How his views will impact federal health care spending is unknown. See what we found.
Marc Viscogliosi has been recognized by M&A Advisor as a winner of the publication’s '2010 40 UNDER 40' awards.
Robert Goldberg, M.D., wanted his day in court. He got it and lost. Now he’s amending a whistleblower suit to make his case in a new court—the court of public opinion. He’s accusing former colleagues of cheating Medicare. The government hasn’t joined in. His former colleagues say he has a vendetta. It’s an Ortho Rumble, Chicago style.
Sam Figg, a senior orthopedics industry veteran, is the new director of research of Fort Wayne, Indiana-based PearlDiver Technologies.
We are entering a new era as reviewers at insurance carriers require more evidence before approving spinal procedures. One reviewer, Gaetano Scuderi, M.D., has some lessons for his colleagues on navigating this new environment. Read them here.
Zimmer and one of its physician/consultants had a very public divorce over differences regarding the company’s NexGen knee. The New York Times printed the physician’s side. This week we offer the company’s response. What’s needed to avoid these situations in the future? Read on..
A group of physicians says that the new health care law denies their rights to own and operate their own hospital. They have rebelled and gone to court to fight for every American physician’s right to due process and equal protection under the law.
Johnson & Johnson conducted its bi-annual device meeting with analysts on June 3. What’s new for the DePuy franchise? Products, strategies and, surprisingly, a self described “opportunity” for the company in a tougher regulatory environment. Read what Mike Mahoney, DePuy’s happy warrior had to say.
Brad Bishop was named the first Executive Director of Warsaw, Indiana-based OrthoWorx on June 3. He will take his post on June 23.
What do patients think about their surgeon’s relationship with device companies? We know what prosecutors and Senator Grassley think. Now, thanks to a survey from the Mayo Clinic, we have the first hard evidence of what patients think. There’s good news and bad news.
Jeff Shuren, M.D., came to a Town Hall Meeting in Minnesota to sell a more open, consistent and transparent FDA. Minnesota is home to more than 300 medical firms. So he also got an earful. How did he respond? Read on.
Promising to meld medicine, science and government, William R. Martin III, M.D., becomes the new Medical Director of the American Academy of Orthopaedic Surgeons.
Providers and manufacturers who want the clearest “picture” of the total economic costs of orthopedic devices and procedures, now have a tool to measure the cost effectiveness of their work. See the presentation from the folks at Zimmer that won a “Best of Category” award at AAOS.
The last two SAS meetings suffered from declining attendance and questions abound about the future of the Society. Former NASS president and newly elected SAS President Tom Errico, M.D., makes a spirited case for an international society for spine surgeons. Is SAS growing up or down? According to Errico…the answer is both.
What Pandora’s Box of legal issue governing patent rights over stem cell therapies for promoting bone growth will be unleashed by NuVasive’s lawsuit against Orthofix? We won’t know for a while, but read here to learn what the fuss is about.
Tom "Tiger" Buford has joined Active Implants Corporation as Vice President, Global Research & Development. We hope he keeps his blog!
CareFusion claims Medtronic/Kyphon cheated in achieving a near monopoly in the kyphoplasty market. They have launched their own product and are suing Medtronic for antitrust violations. Then Stryker joined the fun. It’s a whole new ballgame in kyphoplasty.
Dr. Richard Deyo says complex spine surgeries in the elderly for lumbar stenosis are growing much faster than simple fusion surgeries. Why? Partly because of money, ego, and marketing. NASS’ Dr. Ray Baker and his colleagues agree with the data, but not the conclusion.
MAKO Surgical Corp. has filled two newly created senior vice president slots.
The health care reform bill will make everybody a winner. So says Bill Frist, cardiologist, hospital owner, and former leader of Republicans in the U.S. Senate. But, what does he know? It also means more patients, more units sold, longer wait times and more Sunshine. We have the key orthopedic issues here.
Donald Berwick, M.D., MPP, FRCP and CEO of the Institute for Healthcare Improvement, will reportedly, be appointed by President Obama to be the new head of CMS. The expected appointment is already controversial.
For the second time the FDA’s Ortho Panel found ReGen’s knee device to be safe. But the panel wasn’t convened to consider evidence. This was Act II of the political theater that has industry nervous about cleared devices. See what the panelist and industry had to say at the meeting.
The passage of the Presidency of the American Academy of Orthopaedic Surgeons from Joseph Zuckerman, M.D., to John Callaghan, M.D., mirrors the nation’s debate over the future of health care in the U.S. Read what they told OTW in New Orleans.
Clearly ReGen is not getting a fair shake but has the FDA crossed a critical line and denied ReGen legal and statutory due process? If so, then the FDA’s “redo” of ReGen Biologics' device clearance is a “very dangerous” precedent and requires broad industry comment and action.
Dr. Donna-Bea Tillman is leaving her post at the FDA as the director of the office of device evaluation. She will join Microsoft's development efforts in medical information technology systems.
The debate over the government’s medical response to Haiti and the involvement of civilian surgeons continues. Without civilian surgeons, thousands of injured might have gone untreated. How will this debate impact how surgeons join relief efforts in the future? See what we found.
Are physician-owned distributorships (PODs) illegal shell entities that simply direct remuneration to physicians, or are they a legal way to reduce health care costs, increase hospital profits and give physicians some control over their own means of production? Where you stand depends on where you sit.
Surgeons came home from Haiti disillusioned and angry over U.S. government relief efforts. Military surgeons say their civilian colleagues have little experience in disaster medicine and should leave it to the pros. They find common ground in OTW. See what good has come from this.
The devastating earthquake in Haiti offered one of the greatest challenges of our lifetime to the orthopedic community of care givers, professional societies and device companies around the world. How did the community respond? Read it here.
Jeffrey Shuren, M.D., J.D., has been named the permanent head of the device division at the Food and Drug Administration.
NASS jumped into the XLIF reimbursement fray by telling insurance carriers that the procedure was not experimental or investigational. As in the vertebroplasty situation, the Society defended its position as the authoritative voice for defining high quality, evidence-based spine care. Read their rationale here.
Ken Reali, former Sr. VP and General Manager of Smith & Nephew's Biologics and Spine Business, is TranS1's new president and COO.
Jeff Paulsen is Zimmer's new Group President, Global Business. He is the former president of Stryker's orthopedic reconstructive division.
Combatants in the healthcare debate will spend over $1 billion to make sure they have a seat at the table and not end up an item on the menu. See who is spending big, raking in campaign contributions and who may end up on the menu before it’s all over.
Disruption of surgeon/industry relationships, a dysfunctional FDA and the introduction of comparative effectiveness may have caused companies to slow their development of new products in 2009. But as the year came to an end, the flow of development resumed. How will we remember 2009?
Think it’s tough to get a new technology through the FDA? Try getting it through the Taliban. The human drive for innovation can take place in the most unexpected times and places. Read how Afghan surgeon Lt. Col. Mohammad Wardak, M.D., created the Afghan Device.
NuVasive fights back and says there are no coding or reimbursement issues for its XLIF procedure. But questions about future reimbursements and a slew of short sales have cut the company’s market cap by almost $600 million in the last two months. Read what company CEO Lukianov told analysts on November 30.
Cigna is about to review its previous coverage decision that said NuVasive’s XLIF was “unproven.” Their review is being watched to see if other carriers will follow suit and whether or not another effort will be made to create a new CPT code for the procedure.
Michael Lambert became NuVasive's new Chief Financial Officer on November 9.
Ray Baker, M.D., NASS’ new president and a new generation of society leaders are making a clear statement about the future of spine care. So why are some observers asking whether NASS represents the best interest of surgeons? Interesting times at NASS.
The FDA Ortho panel said no to another spine device in November. A “fog of data” left panel members in a state of inconclusiveness. Did Zimmer’s PMA application do a disservice to the Dynesys dynamic stabilization system? What happened? Read it here.
Stryker’s indictment over the allegedly illegal marketing of OP-1 is just the latest in a series of adverse events for the company and its bone growth product. The indictment may also be vindication for a surgeon accused of being less than truthful by a U.S. Senator.
The FDA is considering clawing back the clearance it granted to ReGen Biologic’s Menaflex implant. It accuses ReGen of being “aggressive” and caused the agency to ignore its own rules. ReGen has been demonized in the process and all device manufacturers have to ask, who is next?
Ninety-five of 344 presentations made by physicians at AAOS’ 2008 meeting failed to disclose industry ties. What caused this failure and what is the Academy doing to assure that the 2010 meeting is “disclosure compliant”? AAOS President Joseph Zuckerman, M.D., explains it all to OTW readers in a recent interview.
CMS is considering revisions to its spine fusion procedure ICD codes. Those codes are the “devil in the details” of reimbursement. CMS hasn’t heard from the little guys, says an industry consultant. If your technology involves words like DLIF, XLIF, or AxiaLIF, read on and submit your comments to CMS by November 20.
Frank Herrington joined Custom Spine this past March as Vice President of Sales for the Southeast Region. On September 8, the company announced that he was being promoted to Senior Vice President of Sales and Marketing.
OP-1 is the same as InFuse? Apparently Senator Chuck Grassley thinks so. In an attempt to bully a surgeon and an institution, the good senator is bucking an FDA panel and other experts to question why Dr. David Polly used InFuse instead of OP-1.
Warsaw, Indiana, has been one of the most successful little communities in America. Now it wants to change. Is mythical “Orthoville” about to become “OrthoWorx?” What’s causing the good citizens of Warsaw to redefine their community and future? Read it here.
Family is coming first for Kevin O'Boyle. O'Boyle, who has been NuVasive's financial chief as the company grew from a small spine company to a publicly traded powerhouse over the last six years, is planning on leaving NuVasive by the end of the year.
Joe Zuckerman, M.D., and the AAOS publicly chastised the president of the United States after he made an inaccurate statement about surgeons at a recent town hall meeting. Why did Joe take on the leader of the free world? Read it here.
Take charge of your own compliance management. That’s the lesson from spine surgeon David Polly, M.D. It’s also the advice of legal expert Mark DuVal. Read DuVal’s 10-point checklist for keeping yourself safe in the crosshairs of public scrutiny.
David Polly, M.D., Chief of Spine Surgery at the University of Minnesota, has also felt the sting of adverse headlines and investigators from Senator Grassley’s office. His discussion of the role of the surgeon at research institutions and how to reconcile modern funding for studies and surgeon consulting relationships with objective medicine is refreshing, enlightening and, most of all, accurate. This is one of the best reviews of this subject we’ve ever published.
Hansen Yuan, M.D., resigned from the Board of Directors of NuVasive, Inc. on August 8, 2009. He resigned before his term was due to expire at the company’s 2011 annual meeting.
Vertebroplasty offers no benefit over a "control intervention" procedure in treating VCFs. That's the conclusion of two new studies and adds fodder to the debate over comparative effectiveness and payer coverage. What are the implications for patients, hospitals and suppliers? Find out here.
UCLA's investigation of Jeff Wang, M.D., is exposing potential institutional mismanagement and confiscatory rules that affect legitimate consulting contracts coming to its best and brightest researchers. Why is the institution attacking one of the profession's brightest stars? Read it here.
Former prosecutor Christopher Christie awarded tens of millions of dollars in no-bid contracts to political friends like John Ashcroft to monitor orthopedic companies. Now Democrats accuse him of taking money from those friends to fill his campaign coffers.
Anthony Viscogliosi trotted the globe while economies were crashing and raised $144 million for small bones and ankles. The Summer of 2009 is when the value of orthopedics was recognized. See what Tony says this means for orthopedics.
Ray Elliott, the former boss of Zimmer who believed that an engagement with Wall Street Analysts and competitors was a full-body contact sport, is back as head of a medical device company.
Healthcare reform is moving towards a frantic finish after the Fourth of July congressional recess. The debate about the need for reform is over. The debate now is over winners and losers. Read our update.
Prosecutors accuse Synthes executives of conducting an illegal clinical trial, promoting off-label use of a bone filler that resulted in the death of three people, and lying about it to FDA investigators. Read our take on the 58-page indictment.
Are Tony Yeung, M.D., and his band of spine endoscopic MIS brethren prepared to go mainstream? Their 22nd meeting in Phoenix provided insights to the future of their society and their subspecialty. Read our take on the meeting.
Michael Mainelli, Jr., is the new President and CEO of Memphis-based Active Implants Corporation.
Craig Corrance, the twenty-year spine industry vet had only been in his chair as president of Centinel Spine for about eight months when a recruiter for Applied Spine Technologies (AST) came calling earlier this year.
Dr. Maurice Muller, “Orthopedic Surgeon of the Century, ” and architect of modern internal fixation is remembered by friends and colleagues in Orthopedics This Week. His contributions to orthopedics are breathtaking and his legacy is enduring. What made him special? Read it here.
When New Jersey’s attorney general launched a high-profile investigation over the financial disclosures of ProDisc clinical investigators in 2008, the truth took a hit in the media. Now Synthes and New Jersey are at peace. What happened?
Motion preservation of the spine is no longer a revolutionary concept. Demonstrating its socioeconomic benefits and convincing private and public payers to reimburse for the procedures will be SAS' next big challenge. Who will be the champion?
Jeff Bierman says bone stimulation device makers cheated the government out of millions by selling, not renting the devices to patients. Now his whistleblower case is unsealed and the U.S. Attorney in Boston is issuing subpoenas. Now what?
Reasonable and necessary isn't going to cut it anymore if the $1.1 billion provision in the stimulus package for creating a comparative effectiveness research tool becomes federal policy. Who will win and lose? Read it here.
