ATLANTA, Dec. 3, 2025 /PRNewswire/ — MiRus is excited to announce that patients who benefit from health coverage through Centers for Medicare and Medicaid Services (CMS) have been the beneficiary recipients of the latest technology called EUROPA® Posterior Cervical (PCF) System, based on it’s proprietary rhenium alloys, for treatment of the cervical and upper thoracic spine. The EUROPA® PCF system had received New Technology Add-on Payment (NTAP) from CMS earlier this year.
MiRus Announces First Cases with EUROPA® Posterior Cervical Fusion System with New Technology Add-on Payment (NTAP)
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With rising cost of healthcare and tightening budgets, hospitals struggle to provide adequate care for the most vulnerable and those in critical need of lifesaving surgery like complex posterior cervical procedures. The EUROPA® PCF system received Breakthrough Device Designation by the FDA which meant this was meaningfully different technology that will benefit a broader range of patients, where currently surgeons struggle with hardware prominence, skipping levels, less biologics, quad rods and connectors and many other compromises they make during spine surgery in the posterior cervical spine.
“This low-profile system, built from next-generation alloys, allows me to instrument both C6 and C7 without having to choose which level to skip in challenging cervico-thoracic reconstructions,” said Jose A. Canseco, MD, PhD, Assistant Professor of Orthopedic Surgery at Thomas Jefferson University. “It lets me avoid bulky quad-rod constructs and cumbersome connectors, which consume valuable real estate in a highly constrained corridor. Instead, I can use a seamless 2.9 mm–to–4.5 mm transition rod, which is particularly advantageous in complex chin-on-chest deformity cases where every millimeter matters.”
Dr. Canseco added, “I’m glad to be able to bring this technology to our community at institutions such as Capital Health, where there is a strong commitment to innovation and improving patient outcomes.”
“We are pleased that CMS has recognized the EUROPA® PCF System as a better option for treating the complex clinical cervical and upper thoracic spine procedures by awarding the NTAP designation. CxOs of hospitals tell us that they want broader adoption of this new technology because they can treat more CMS patients, and avail of the CMS incentives to help hospitals offset cost pressures,” commented Mahesh Krishnan, Chief Commercial Officer.
“We continue to innovate and use the MoRe® Superalloy for various applications in Extremities and Structural Heart that will demonstrate clinical advantage and bring them to broader populations,” continued Mr. Krishnan, “this NTAP is just the beginning of many meaningful contributions that MiRus will make in the upcoming years.”
About MiRus, LLC.
MiRus is a life sciences company headquartered in Marietta, Georgia that has developed and is commercializing proprietary novel biomaterials, implants and procedural solutions for the treatment of spine, orthopaedic and structural heart disease. Inspired by the pioneering material science of NASA for rocket engines, MiRus has created Rhenium based medical alloys that are transforming medicine by making surgeries less invasive and implants safer and more durable. Find out more information about MiRus at www.mirusmed.com.
Statements made in this press release that look forward in time or that express beliefs, expectations or hopes regarding future occurrences or anticipated outcomes are forward-looking statements. A number of risks and uncertainties such as risks associated with product development and commercialization efforts, expected timing or results of any clinical trials, ultimate clinical outcome and perceived or actual advantages of the Company’s products, market and physician acceptance of the products, intellectual property protection, and competitive offerings could cause actual events to adversely differ from the expectations indicated in these forward looking statements. The Siegel TAVR system is an investigational device and not FDA approved.
Contact:
Mahesh Krishnan
Chief Commercial Officer, MiRus
mkrishnan@mirusmed.com
770-317-5564
SOURCE MiRus
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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?
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.
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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