Centinel Spine, LLC, the largest privately-held spine company focused on anterior column reconstruction, today announced that the first implantation took place in an Investigational Device Exemption (IDE) study monitored by the Food and Drug Administration (FDA).
| NEW YORK, Aug. 22, 2019 /PRNewswire/ -- Centinel Spine, LLC, the largest privately-held spine company focused on anterior column reconstruction, today announced that the first implantation took place in an Investigational Device Exemption (IDE) study monitored by the Food and Drug Administration (FDA). The two-level IDE clinical trial is a prospective, randomized, multi-centered clinical study evaluating two different cervical total disc replacement (TDR) devices at multiple sites across the United States.
The ongoing clinical trial compares the prodisc C Vivo and prodisc C SK devices with an approved 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 TDR product outside of the United States. 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. Multiple centers that have significant experience with TDR procedures are participating in the study. 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 endplates. The interface variations will enable surgeons to better match the implant to a patient’s anatomy. “The first study implantation is an important first step towards obtaining sales and marketing approval of the prodisc C Vivo and prodisc C SK products in the United States. The prodisc platform is already the most clinically studied and proven TDR technology in the world with more than 450 papers, and this study will add to the body of evidence,” 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.” “This case was the perfect justification of the intent behind the design of these devices. The patient had severe neck pain and radiating neurologic symptoms, associated with disc degeneration and spinal stenosis, that worsened despite months of non-operative treatment.” says Jason Tinley, MD, orthopedic spine surgeon and founder of DFW Center for Spinal Disorders in Dallas-Fort Worth, TX. “I was able to select the most stable and least invasive implant that best suited the patient’s anatomy, providing me with a significant advantage as I seek to optimize patient clinical results and preserve spinal motion with arthroplasty,” Dr. Tinley adds. For additional information and inclusion/exclusion study criteria, please refer to 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: Varun Gandhi
SOURCE Centinel Spine |
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