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Home/Spine/Laser Spine Institute Partnering With Spinal Kinetics, Titan Spine
Spine

Laser Spine Institute Partnering With Spinal Kinetics, Titan Spine

November 18, 2015 2 min read Premium comments

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Laser Spine Institute Partnering With Spinal Kinetics, Titan Spine
Logo courtesy of Laser Spine Institute, Spinal Kinetics and Titan Spine
Secondary

Laser Spine Institute has announced that it will partner with two companies for two upcoming clinical trials: Spinal Kinetics and Titan Spine. Patients will be enrolled at Laser Spine Institute’s ambulatory surgery center (ASC) in Tampa, Florida.

According to the news release, “In an FDA-regulated clinical trial studying the M6-C artificial cervical disc, considered by some to be the most advanced technology in motion preservation, Laser Spine Institute will partner with Spinal Kinetics by enrolling patients in the anterior cervical discectomy and fusion (ACDF) control group arm of the trial…”

“The clinical trials with Titan Spine will involve transforaminal lumbar interbody fusion procedures for up to 25 clinical trial patients. The procedure fuses the anterior and posterior columns of the spine through a posterior approach…”

Laser Spine Institute President David Pillsbury, told OTW, “Whether it’s through the introduction of new technology, or just simple improvements in our processes, we hope to be stewards of change with our clinical trials. While our patients will continue to receive our current standard of care, we’re hoping to make a big impact—particularly in pain levels and disability outcomes—in the least invasive way possible.”

John Rosich, National Sales Director-Target Accounts for Titan Spine, told OTW, “Titan Spine has enjoyed a long standing relationship with Laser Spine Institute’s newly appointed Director of Clinical Research, Dr. Reggie Davis, due to his interest in Titan’s proprietary surface technology and the potential benefits it has for his patients. Dr. Davis is the principal investigator for Titan’s TLIF study and became the main conduit between Titan Spine and Laser Spine Institute when he joined their staff several months ago. We are pleased to have Laser Spine Institute as one of the research sites for our clinical study.”

Neal Defibaugh, Vice President of Clinical and Regulatory Affairs, Spinal Kinetics, told OTW, “Laser Spine Institute was selected to participate in our M6-C artificial cervical disc Pivotal Trial as a result of two very important factors. The first is Laser Spine Institute’s recent appointment of Dr. Reginald Davis as Director of Clinical Research for the organization’s strategic clinical trial platform. Dr. Davis’ leadership and experience in clinical research is well known and respected throughout the spinal community and regulatory bodies. The opportunity to have Dr. Davis involved as one of our principal investigators continues our strong commitment to having highly respected physicians and their teams involved in proving the safety and efficacy of the M6-C artificial cervical disc.”

“The second reason for selecting Laser Spine Institute as a study center is its clinical research infrastructure and commitment to pioneering the advancement of new technologies for minimally invasive spinal surgery. As it is for Spinal Kinetics, the focus and priority for Laser Spine Institute is the patient. Providing the most innovative technology and outcomes for the patient is a shared core value. We believe the M6 disc is a technology that will help improve a cervical arthroplasty patient’s quality of life. Spinal Kinetics is very pleased to have Laser Spine Institute as a partner with us in bringing this technology to market.”

React:

Discussion

14
DS
Dr. Sarah MitchellOrthopedic Surgeon · Mayo Clinic

This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?

8
JT
James Thornton, MDSpine Fellow · HSS

Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.

5
RP
R. PatelSports Medicine · Stanford

We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.

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