Centinel Spine has announced US Food and Drug Administration (FDA) pre-market application (PMA) approval for one-level indications for three additional cervical total disc replacement (TDR) devices—prodisc C Vivo, prodisc C Nova, and prodisc C SK.
The prodisc C Vivo and prodisc C Nova products have been in use outside the US since 2009, and prodisc C Vivo is currently the most frequently implanted TDR outside of the USA, say Centinel Spine.
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, add the company. All of the products incorporate prodisc CORE technology.
Jason Tinley, orthopaedic spine surgeon and founder of DFW Center for Spinal Disorders (Dallas-Fort Worth, USA), said: “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. 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.”
Centinel Spine’s CEO, Steve Murray, added: “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.”