Sam Brusco, Associate Editor07.13.22
Centinel Spine has gained U.S. Food and Drug Administration (FDA) approval for 1-level indications for three additional cervical total disc replacement (TDR) devices: prodisc C Vivo, prodisc C Nova, and prodisc C SK.
prodisc C Vivo and Nova have been used in the U.S. since 2009, and prodisc C Vivo is currently the most frequently implanted TDR outside the U.S., according to the company. prodisc C Vivo has keel-less endplates and convex, superior endplate to match more concave vertebral anatomy, while prodisc C SK and Nova have flat endplates with low-profile keels to better match flat vertebral anatomy.
"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," Jason Tinley, MD, orthopedic spine surgeon and founder of DFW Center for Spinal Disorders told the press. "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."
Centinel Spine is also enrolling for two-level prospective, randomized, multi-centered clinical study evaluating prodisc C Vivo and SK.
prodisc C Vivo and Nova have been used in the U.S. since 2009, and prodisc C Vivo is currently the most frequently implanted TDR outside the U.S., according to the company. prodisc C Vivo has keel-less endplates and convex, superior endplate to match more concave vertebral anatomy, while prodisc C SK and Nova have flat endplates with low-profile keels to better match flat vertebral anatomy.
"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," Jason Tinley, MD, orthopedic spine surgeon and founder of DFW Center for Spinal Disorders told the press. "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."
Centinel Spine is also enrolling for two-level prospective, randomized, multi-centered clinical study evaluating prodisc C Vivo and SK.