WEST CHESTER, PA — Centinel Spine®, LLC has received U.S. Food and Drug Administration (FDA) Premarket Approval for two-level indications of its prodiscC Vivo and prodiscC SK cervical total disc replacement (TDR) devices — a regulatory milestone that expands treatment options for patients suffering from degenerative cervical spine conditions.
The approval allows both devices to be used for the reconstruction of vertebral discs from C3 to C7 following discectomy at one or two contiguous levels. The decision builds on the company’s July 2022 FDA approval for one-level use and reflects the successful completion of a landmark Investigational Device Exemption (IDE) Clinical Study, which demonstrated superior outcomes compared to existing TDR systems.
Since the original one-level approval, nearly 20,000 prodiscC Vivo and prodiscC SK levels have been implanted in the U.S. by more than 1,100 surgeons. The company’s prodisc Match-the-Disc™ System is now the first and only cervical TDR platform offering two distinct devices approved for both one- and two-level procedures.
“This is a historic milestone for Centinel Spine and further advances treatment options for spine surgeons and their patients,” said CEO Steve Murray. “This 2-level approval advances the concept of uniquely matching the disc to each level of the patient’s cervical spine and is a major step forward in total disc replacement.”
The IDE study enrolled 480 patients across 31 centers, with data from 433 subjects forming the basis for FDA approval — the largest cohort ever used to support a cervical TDR PMA. At 24 months, patients treated with the prodiscC Vivo and prodiscC SK demonstrated a composite clinical success rate of 87.1%, the highest among two-level cervical TDR devices currently approved. More than 93% of participants reported significant improvement in neck function, while nearly 97% avoided secondary surgical interventions at the treated levels.
Spine surgeons involved in the trial emphasized the clinical importance of design versatility. Dr. Jad Khalil of Michigan Orthopaedic Surgeons described cervical disc arthroplasty as “a great alternative to traditional fusion surgery,” noting that the system’s ability to match implant design to individual anatomy “provides a more tailored approach to the procedure.”
The prodiscC Vivo, in use internationally since 2009, features a keel-less insertion and anatomically contoured endplate for optimized fit and fixation. The prodiscC SK offers a low-profile central keel and flat endplate to improve alignment and ease of implantation. Both devices are built on the company’s established prodisc CORE technology, with more than 275,000 implants performed worldwide.
With this approval, Centinel Spine remains the only company in the U.S. offering total disc replacement solutions cleared for one- and two-level use in both the cervical and lumbar spine — marking another step forward in motion-preserving spinal care.
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