Centinel Spine, LLC, a leading global medical device company addressing cervical and lumbar spinal disease through anterior surgical access, today announced U.S. Food and Drug Administration (FDA) Pre-Market Application (PMA) Approval for 1-level indications for three additional cervical total disc replacement (TDR) devices: prodisc C Vivo, prodisc C Nova, and prodisc C SK. Along with the currently available prodisc C implant, which continues to be widely used throughout the U.S., Centinel Spine now has the broadest offering of cervical TDR solutions in the world to address surgeon preference and individual patient anatomy.
The TDR market is expected to remain the fastest growth segment within the spine industry, growing globally in excess of 11% CAGR and reaching $2.69B by 2026 (Artificial Disc Market Insights, Competitive Landscape and Market Forecast-2027, DelveInsight Business Research LLP, 2022). The prodisc platform has been a pioneering TDR technology and a major contributor to this growth with continuous innovation over the past 30 years. Centinel Spine is the only company offering multiple cervical TDR options for surgeons to select from based on each patient’s anatomy at the surgical level.
The prodisc C Vivo and prodisc C Nova products have been in use outside the U.S. since 2009, and prodisc C Vivo is currently the most frequently implanted TDR outside of the U.S. The prodisc C Vivo product has keel-less endplates including a convex, superior endplate to match more concave vertebral anatomy, while the prodisc C SK and prodisc C Nova implant designs have flat endplates with low-profile keels to better match flat vertebral anatomy. All of these products incorporate prodisc CORE technology, the basis behind the predictable clinical outcomes of every prodisc device after 30 years and over 225,000 implantations, worldwide.
“The FDA approval of the prodisc C Vivo, Nova, and SK devices offers the surgeon a new level of modularity and stability for cervical disc replacement,” says Jason Tinley, MD, orthopedic spine surgeon and founder of DFW Center for Spinal Disorders in Dallas-Fort Worth, TX. “The patient can now receive an implant that best conforms to their anatomy intraoperatively, with variable endplate characteristics that best suit the surgeon’s preference of technique,” Dr. Tinley adds.
Centinel Spine’s CEO, Steve Murray, stated, “Anatomic cervical total disc options provide surgeons the benefit of selecting implants to optimally fit the disc to each patient. This is unique and represents a major advancement in spinal reconstruction. PMA approval for these three additional devices is a significant accomplishment and we look forward to bringing the new prodisc options to the market in Q4 2022.”
Centinel Spine also continues to enroll for a two-level prospective, randomized, multi-centered clinical study evaluating prodisc C Vivo and prodisc C SK.
Source: Company Press Release
