NEW YORK, July 18, 2019 /PRNewswire/ -- Centinel Spine, LLC, the largest privately-held spine company focused on anterior column reconstruction, today 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).
About Centinel Spine, LLC
Centinel Spine®, LLC is the largest privately-held spine company focused on anterior column reconstruction. The company offers a continuum of trusted, brand-name, motion-preserving and fusion solutions backed by over 30 years of clinical success—providing the most robust and clinically-proven Total Disc Replacement and Integrated Interbody™ portfolios in the world.
The company began operations in 2008 through the merger-acquisition of two pioneering medical device companies—Raymedica, LLC and Surgicraft, LTD. In 1988, UK-based Surgicraft launched the first Stand-Alone/No Profile® anterior lumbar interbody fusion device in the world, which was the basis for future generations of the market-leading Integrated Interbody technology platform known today as STALIF®. Today, Centinel Spine still embraces the pioneering culture developed at both originating companies and continues its corporate mission to become the worldwide leading company addressing spinal disease anteriorly with the widest breadth and depth of technology platforms.
The company recently acquired the prodisc® Total Disc Replacement Technology Platform—the most extensive cervical and lumbar motion-preserving reconstruction portfolio available today. With the addition of prodisc, Centinel Spine stands alone as the only company with comprehensive motion-preserving and fusion solutions for both cervical and lumbar anterior column reconstruction.
Centinel Spine derived its name from the "Sentinel Sign", the radiographic confirmation of a successful fusion anterior to the interbody device.
For more information, please visit the company's website at www.CentinelSpine.com or contact:
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SOURCE Centinel Spine