MiRus has announced that its EUROPA® Posterior Cervical Fusion (PCF) System has been granted New Technology Add-on Payment (NTAP) status by the Centers for Medicare and Medicaid Services (CMS), marking a key advancement in spine surgery options. The system’s usage of MoRe, the company’s patented rhenium-based alloy, and its proven ability to treat disorders affecting the cervical and upper thoracic spine are the reasons for this recognition. The 2.9 mm rod used in the EUROPA® PCF system is made of MoRe and is significantly smaller than rods used in traditional systems. This smaller rod design enables lower-profile tulips in pedicle screws, supporting less invasive surgical procedures and minimizing hardware prominence—an essential benefit for patients with smaller anatomies.
Despite its reduced diameter, the MoRe rod exhibits enhanced strength, stiffness, and fatigue resistance. These qualities offer a meaningful reduction in the likelihood of rod breakage, an issue often encountered with existing spine systems. The innovative nature and clinical potential of the EUROPA® PCF System earned it the Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA), further reinforcing its impact on the field of spinal surgery.
Dr. Han Jo Kim, a Professor of Orthopedic Surgery at the Hospital for Special Surgery in New York, highlighted the effectiveness of MiRus’ MoRe rods, noting successful outcomes in complex cases using the 4.5 mm rod system. He emphasized the material’s promise in offering stronger, more durable, and lower-profile spinal implants that align with the evolving needs of surgical practices.
MiRus executives echoed this sentiment, celebrating the NTAP designation as a significant achievement that supports both patient access and hospital reimbursement. They underscored the ongoing challenge of high revision rates and implant failures in spine surgery, expressing confidence that the EUROPA® PCF System would allow surgeons to deliver more durable, less invasive treatments for cervicothoracic spine conditions, ultimately advancing the quality of care.
