NEW YORK: Centinel Spine, LLC, the largest privately-held spine company focused on anterior column reconstruction, announced that it received Investigational Device Exemption (IDE) approval from the Food and Drug Administration (FDA) to initiate a two-level clinical trial with two different prodisc C Anterior Cervical Total Disc devices - prodisc C Vivo and prodisc C SK.
The clinical trial will compare the prodisc devices with an approved total disc replacement (TDR) product as a control in order to validate their safety and effectiveness. The prodisc C Vivo product has been used since 2009 and is the most frequently implanted total disc replacement outside the US. The prodisc C SK implant is a variation of the prodisc C Nova device, an implant successfully used outside of the United States since 2010. The company plans to begin the clinical trial immediately in multiple centers across the United States that have significant experience with TDR procedures.
The prodisc C Vivo and prodisc C SK products utilize the same mechanism-of-action as the currently marketed prodisc C implant, a product that was granted PMA approval in 2007 and continues to be successfully used today throughout the United States. The prodisc C Vivo and prodisc C SK products principally differ from prodisc C in the way in which the devices interface with the vertebral body. The interface variations will enable surgeons to better match the implant to a patient's anatomy.
The two-level IDE clinical trial will be a prospective, randomized, multi-centered clinical study evaluating the prodisc C Vivo and prodisc C SK products at multiple sites across the United States. The goal of the IDE clinical trial will be to compare prodisc C Vivo and prodisc C SK with an existing TDR device currently approved by the FDA for two-level indications.
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, says Centinel Spine Chairman & CEO, John Viscogliosi. 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, says Armen Khachatryan, orthopedic surgeon at The Disc Replacement Center in Salt Lake City, UT. 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, Dr. Khachatryan adds.
For additional information, including inclusion/exclusion criteria, please see the FDA clinical trials website at www.clinicaltrials.gov (NCT number 04012996).
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