ATLANTA, Aug. 1, 2025 /PRNewswire/ — MiRus has acquired New Know-how Add-on Fee (NTAP) from the Facilities for Medicare and Medicaid Companies (CMS) for the EUROPA® Posterior Cervical System, based mostly on it’s proprietary rhenium alloys, for therapy of the cervical and higher thoracic backbone.
The EUROPA® PCF system is constructed round a 2.9 mm MoRe rod which is far smaller than present industrial methods. The decrease diameter rod permits low-profile pedicle screw tulips resulting in much less invasive surgical procedure and fewer {hardware} prominence in smaller sufferers. Though decrease diameter, MoRe rods present a superior degree of rigidity, energy, and fatigue resistance which reduces the chance of backbone rod fractures in comparison with present methods. The EUROPA® PCF System was awarded Breakthrough Gadget Designation by the FDA.
“I’ve used the 4.5mm MoRe rod TL system for advanced circumstances and have had good outcomes,” said Han Jo Kim MD, Professor of Orthopedic Surgical procedure on the Hospital for Particular Surgical procedure, New York “There’s great potential in what this proprietary alloy (MoRe) can accomplish in backbone surgical procedure, providing implants which can be decrease profile, extra sturdy and stronger.”
“We’re happy that CMS has acknowledged the EUROPA® PCF System because the superior choice for treating the cervical and higher thoracic backbone, enabling hospitals to obtain reimbursement by the NTAP program and making certain Medicare sufferers have entry to this breakthrough know-how,” commented Mahesh Krishnan, Chief Business Officer.
“At the moment the charges of backbone implant failures and revision surgical procedures for sufferers stay unacceptably excessive,” commented Jordan Bauman, VP of Regulatory and High quality. “with EUROPA® PCF, backbone surgeons will have the ability to present sturdy and fewer invasive surgical procedure for his or her cervicothoracic sufferers. That is one other step ahead in our mission to supply much less invasive and extra sturdy gadgets throughout a broad spectrum of illness states.”
About MiRus, LLC.
MiRus is a life sciences firm headquartered in Atlanta, Georgia that has developed and is commercializing proprietary novel biomaterials and implants which can be remodeling medication by making surgical procedures much less invasive and implants safer and extra sturdy. www.mirusmed.com.
Statements made on this press launch that look ahead in time or that categorical beliefs, expectations or hopes relating to future occurrences or anticipated outcomes are forward-looking statements. A variety of dangers and uncertainties equivalent to dangers related to product improvement and commercialization efforts, anticipated timing or outcomes of any medical trials, final medical final result and perceived or precise benefits of the Firm’s merchandise, market and doctor acceptance of the merchandise, mental property safety, and aggressive choices may trigger precise occasions to adversely differ from the expectations indicated in these ahead wanting statements. The EUROPA® Posterior Cervical System isn’t FDA authorized.
* MiRus® , EUROPA®, MoRe® are all logos of MiRus, LLC.
Contact:
Pam Cowart
VP of Scientific Affairs
pcowart@mirusmed.com
770-861-4804
SOURCE MiRus