MiRus Secures NTAP for Innovative EUROPA™ Cervical System
MiRus Secures New Technology Add-on Payment for EUROPA™ System
MiRus has attained a significant achievement by receiving the New Technology Add-on Payment (NTAP) from the Centers for Medicare and Medicaid Services (CMS) for its EUROPA™ Posterior Cervical Fusion System. This innovative system is designed for the cervical and upper thoracic spine, utilizing proprietary rhenium alloys to enhance surgical outcomes.
Transformative Design of the EUROPA™ System
The EUROPA™ Posterior Cervical Fusion (PCF) System stands out due to its sophisticated design, which centers around a 2.9 mm MoRe rod. This smaller diameter, compared to traditional systems, enables lower profile pedicle screw tulips, contributing to less invasive surgical procedures with reduced hardware prominence, especially in smaller patients. Despite its reduced diameter, the MoRe rod ensures exceptional rigidity, strength, and enhanced fatigue resistance, significantly minimizing the risk of spine rod fractures, an issue often faced with current systems.
Expert Validation and Recognition
Medical professionals have expressed enthusiasm about the potential of the EUROPA™ System. Dr. Han Jo Kim, a professor at the Hospital for Special Surgery, commented on the success he has found using the 4.5mm MoRe rod TL system for complex cases. He emphasized the revolutionary potential of this proprietary alloy, highlighting its lower profile and greater durability, which could reshape the approaches to spine surgery.
Significance of CMS Approval
CMS’s endorsement of the EUROPA™ PCF System as a groundbreaking option for treating cervical spine disorders is pivotal. Mahesh Krishnan, the Chief Commercial Officer of MiRus, noted that this recognition would enable hospitals to obtain reimbursement through the NTAP program, ensuring that Medicare patients gain access to this advanced technology.
Addressing Spine Surgery Challenges
Jordan Bauman, the Vice President of Regulatory and Quality, highlighted the pressing issue of spine implant failures. Currently, the rates of such failures and subsequent revision surgeries are concerningly high. The innovations embedded in the EUROPA™ PCF System are expected to offer spine surgeons the ability to perform less invasive operations with more durable outcomes for their patients.
About MiRus, LLC
Headquartered in Atlanta, Georgia, MiRus is a pioneering life sciences company dedicated to the development and commercialization of unique biomaterials and implants. Their mission is to enhance surgical techniques and improve the safety and longevity of implants, ultimately making surgeries less invasive for patients. For more information, visit their official website.
Frequently Asked Questions
What is the EUROPA™ Posterior Cervical Fusion System?
The EUROPA™ PCF System is an innovative surgical system designed for cervical and upper thoracic spine fusion using advanced materials to improve surgical outcomes.
What are the advantages of the EUROPA™ System?
It features a smaller diameter rod that enhances surgical invasiveness, reduces hardware prominence in patients, and provides superior strength and durability.
How has MiRus been recognized for its innovation?
MiRus received the New Technology Add-on Payment (NTAP) from CMS, validating the effectiveness of the EUROPA™ system in spine surgery.
Who can benefit from the EUROPA™ PCF System?
This system is designed to benefit patients needing cervical spine surgery, offering them less invasive options and improved recovery outcomes.
What is the mission of MiRus?
MiRus aims to transform surgical practices by creating less invasive and more durable medical devices that enhance patient care across various medical conditions.
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