WEST CHESTER, PA — Centinel Spine®, LLC has received European Union Medical Device Regulation (MDR) certification for its prodisc C Vivo and prodisc C Nova Cervical Total Disc Replacement (TDR) systems, securing CE marks under the EU’s highest standards for quality, safety, and performance.
The certification establishes the prodisc C Vivo and prodisc C Nova Match-the-Disc™ platform as the first and only cervical TDR system with two MDR-certified devices. Both implants have been in international clinical use since 2009 and, together, are among the most frequently utilized cervical TDR systems worldwide.
“The path to MDR approval is extremely challenging. Centinel Spine was willing to push forward and do what was necessary to provide European surgeons with continued access to a proven life-changing technology such as prodisc. As a surgeon, having continued access to prodisc C Vivo and prodisc C Nova into the distant future was extremely important to me and the resulting care that I am able to provide to my patients,” said Prof. Dr. Christoph Mehren, head of spinal surgery at Schön Klinik in Munich, Germany.
“This marks a pivotal moment for Centinel Spine as an organization. Securing MDR certification for the prodisc C Vivo and prodisc C Nova total disc replacement devices has been a complex and demanding process, but it underscores our commitment to delivering safe, high-quality, and clinically-proven products. A fundamental pillar of our strategic vision is to improve the lives of as many patients as possible worldwide by expanding access to prodisc technologies. Achieving MDR certification represents a critical milestone in realizing that vision,” said Steve Murray, CEO of Centinel Spine.
Product designs target anatomical fit and immediate fixation: prodisc C Vivo features keel-less insertion with an anatomically contoured superior endplate and lateral spikes; prodisc C Nova uses a flat endplate to match flat vertebral anatomy with a tri-keel design for stability. Both incorporate prodisc CORE technology, the platform behind more than 35 years of clinical use and approximately 275,000 implantations globally.
With MDR certification complete, Centinel Spine is positioned to maintain surgeon access across Europe and reinforce its international footprint under the EU’s latest regulatory framework.
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