MiRus Receives New Technology Add-on Payment (NTAP) for EUROPA(TM) Posterior Cervical Fusion System
Saturday, August 9, 2025
ATLANTA, Aug. 1, 2025 /PRNewswire/ -- MiRus has received New Technology Add-on Payment (NTAP) from the Centers for Medicare and Medicaid Services (CMS) for the EUROPA(®) Posterior Cervical System, based on it's proprietary rhenium alloys, for treatment of the cervical and upper thoracic spine.
The EUROPA(® )PCF system is built around a 2.9 mm MoRe rod which is much smaller than current commercial systems. The lower diameter rod allows low-profile pedicle screw tulips leading to less invasive surgery and less hardware prominence in smaller patients. Although lower diameter, MoRe rods provide a superior level of rigidity, strength, and fatigue resistance which reduces the risk of spine rod fractures compared to current systems. The EUROPA(®) PCF System was awarded Breakthrough Device Designation by the FDA.
"I have used the 4.5mm MoRe rod TL system for complex cases and have had good results," stated Han Jo Kim MD, Professor of Orthopedic Surgery at the Hospital for Special Surgery, New York "There is tremendous potential in what this proprietary alloy (MoRe) can accomplish in spine surgery, offering implants that are lower profile, more durable and stronger."
"We are pleased that CMS has recognized the EUROPA(®) PCF System as the superior option for treating the cervical and upper thoracic spine, enabling hospitals to receive reimbursement through the NTAP program and ensuring Medicare patients have access to this breakthrough technology," commented Mahesh Krishnan, Chief Commercial Officer.
"Currently the rates of spine implant failures and revision surgeries for patients remain unacceptably high," commented Jordan Bauman, VP of Regulatory and Quality. "with EUROPA(®) PCF, spine surgeons will be able to provide durable and less invasive surgery for their cervicothoracic patients. This is another step forward in our mission to provide less invasive and more durable devices across a broad spectrum of disease states."
About MiRus, LLC.
MiRus is a life sciences company headquartered in Atlanta, Georgia that has developed and is commercializing proprietary novel biomaterials and implants that are transforming medicine by making surgeries less invasive and implants safer and more durable. 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 EUROPA(®) Posterior Cervical System is not FDA approved.
* MiRus(®) , EUROPA(®), MoRe(®) are all trademarks of MiRus, LLC.
Contact:
Pam Cowart
VP of Clinical Affairs
pcowart@mirusmed.com
770-861-4804
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SOURCE MiRus
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