Centinel Spine LLC announced it received investigational device approval from the FDA to begin a two-level clinical trial for its prodisc C anterior cervical total disc devices: prodisc C Vivo and prodisc C SK.
According to a company press release, the prospective, randomized, multicentered clinical study will compare the prodisc devices with an FDA-approved total disc replacement (TDR) device to validate effectiveness and safety. Centinel Spine will begin the clinical trial immediately at multiple centers in the United States. The interface variations between the prodisc C Vivo and prodisc SK will reportedly allow for surgeons to better match the patient’s anatomy to the implant.
“Approval of the prodisc C Vivo and prodisc C SK products in the United States will enable Centinel Spine to provide the widest range of TDR products to surgeons and patients in the world. The prodisc platform is the most clinically studied and proven TDR technology on the planet,” John Viscogliosi, Centinel Spine chair and CEO, said in the release. “The goal of Centinel Spine is to provide surgeons with multiple clinically proven TDR implant options to match a patient’s anatomy.”