Centinel Spine said yesterday that it won an investigational device exemption from the FDA for a clinical trial of its Prodisc cervical disc implants.
New York City-based Centinel acquired the Prodisc assets from Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Synthes in December 2017 for an undisclosed amount. The FDA IDE covers a two-level study of the company Prodisc C Vivo and Prodisc C SK cervical implants for total disc replacement procedures, compared with an already-approved two-level TDR device.
“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,” chairman & CEO John Viscogliosi said in prepared remarks. “The goal of Centinel Spine is to provide surgeons with multiple clinically proven TDR implant options to match a patient’s anatomy.”
“Once available, the combination of endplate configurations for prodisc C Vivo and prodisc C SK will provide surgeons with the ability to adapt the implant used to the patient’s anatomy,” added Dr. Armen Khachatryan of Salt Lake City’s Disc Replacement Center. “Suiting the implant morphology to the patient anatomy provides me with a significant advantage as I seek to optimize patient clinical results and preserve spinal motion with arthroplasty.”