Centinel Spine, the leading global medical device company focused exclusively on treating cervical and lumbar spinal disease with the most complete and clinically-proven total disc replacement (TDR) technology platform in the world announced EU Medical Device Regulation (MDR) certification for the prodisc C Vivo and prodisc C Nova Cervical Total Disc Replacement systems. The achievement underlines Centinel Spine’s commitment to providing safe, high-quality, proven products.
The Company has successfully completed the registration and certification process for its leading International cervical TDR products in accordance with the new MDR of the European Union. The prodisc C Vivo and prodisc C Nova Cervical Total Disc Replacement systems are now compliant and CE-marked in accordance with the highest European standards of quality, safety, and performance for medical devices. MDR certification ensures medical devices are safe and comply with the latest most stringent regulatory requirements of the European Union.
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Speaking about the MDR certification, Prof. Dr. Christoph Mehren, head of the spinal surgery department at Schön Klinik hospital in Münich, Germany, stated, “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.”
Centinel Spine CEO Steve Murray adds, “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.”
The prodisc C Vivo and prodisc C Nova devices have been in clinical use internationally since 2009 and, together, are one of the most frequently utilized TDR systems in the world. The prodisc C Vivo device offers keel-less insertion and combines a unique anatomically-designed superior endplate with lateral spikes to optimize fit and provide immediate fixation. The prodisc C Nova device features a flat endplate designed to better match flat vertebral anatomy, along with a unique tri-keel design that offers immediate fixation. Both devices incorporate prodisc CORE technology, the basis behind the predictable clinical outcomes of every prodisc device after over 35 years and 275,000 implantations, worldwide.*
