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MiRus's EUROPA™ Posterior Cervical Fusion System Receives NTAP

In a significant advancement in spinal surgery, MiRus has been awarded the New Technology Add-on Payment (NTAP) by the Centers for Medicare and Medicaid Services (CMS) for its groundbreaking EUROPA® Posterior Cervical Fusion System. This recognition highlights the system's potential to enhance treatment for patients with cervical and upper thoracic spine issues.

Innovation in Design

The EUROPA® PCF System utilizes a unique proprietary material known as MoRe, which is a rhenium alloy. This innovation allows for the incorporation of a 2.9 mm rod that is smaller than those typically seen in the market today. The advantages of using a lower diameter rod are significant, particularly in minimizing invasiveness during surgery. This results in lower-profile pedicle screw tulips, which ultimately leads to lesser hardware prominence in smaller patients.

Despite its reduced size, the MoRe rods maintain superior rigidity, strength, and fatigue resistance. These characteristics are crucial in lowering the risk of spine rod fractures, a common concern with current spinal systems. Indeed, the EUROPA® PCF system's design has earned it the Breakthrough Device Designation from the FDA, marking it as a prominent player in modern orthopedic surgery.

Expert Endorsements

Dr. Han Jo Kim, a Professor of Orthopedic Surgery at the Hospital for Special Surgery in New York, has previously utilized the 4.5mm MoRe rod system for complex spinal cases with promising results. He emphasizes the extraordinary potential of this proprietary alloy in transforming spine surgery, allowing for implants that are not only lower profile but also more durable and resilient.

Mahesh Krishnan, Chief Commercial Officer of MiRus, expressed pride in CMS's recognition of the EUROPA® PCF System as an advanced option for treating spinal ailments. This recognition is crucial because it enables hospitals to receive reimbursements through the NTAP program, thereby ensuring that Medicare patients have access to this revolutionary technology.

Addressing Failures in Spine Surgery

With spine implant failures and the need for revision surgeries remaining at unacceptably high levels, the EUROPA® PCF system presents a promising solution. Jordan Bauman, Vice President of Regulatory and Quality at MiRus, noted that the new system enables spine surgeons to perform more durable and less invasive surgeries for cervicothoracic patients. This is a significant stride in their ongoing mission to deliver less invasive and longer-lasting medical devices across various medical conditions.

About MiRus, LLC

Founded in Atlanta, Georgia, MiRus is dedicated to transforming medical practices by developing and commercializing novel biomaterials and implants. Their focus is on making surgeries less invasive while ensuring implants are both safer and more durable. More information can be found at mirusmed.com.

Looking Ahead

While this announcement is impactful, it's essential to recognize that the EUROPA® Posterior Cervical Fusion System is still in the process of receiving FDA approval. Future developments will need to navigate various challenges and uncertainties associated with product development; however, the potential benefits of the system are clear.

As advancements continue, MiRus is poised to play a vital role in the evolution of spinal surgeries, providing hope for both surgeons and patients alike seeking more effective treatment options.