Centinel Spine now has four FDA-approved cervical total disc replacement (TDR) devices for 1-level indications, offering the broadest spectrum of solutions to address surgeon preference and individual patient anatomy.
- Centinel Spine continues its leadership in total disc replacement, becoming the first-and-only company with a portfolio that allows matching the disc to patient anatomy.
- The variety of cervical TDR endplate configurations, coupled with the proven and well-documented prodisc® CORE technology, represents a major advancement in patient care.
- The prodisc technology is the most studied and clinically-proven TDR system in the world, validated by over 540 published papers.
West Chester, PA, September 7, 2022 – Centinel Spine®, LLC, a leading global medical device company addressing cervical and lumbar spinal disease through anterior surgical access, today announced the first implantation of its prodisc® C Vivo Cervical Total Disc Replacement (TDR) product. In July, the company received U.S. Food and Drug Administration approval for 1-level indications for prodisc C Vivo, prodisc C SK, and prodisc C Nova. Along with the currently available prodisc C implant, which remains the most studied TDR technology, Centinel Spine now has the broadest offering of cervical TDR solutions in the world to address surgeon preference and individual patient anatomy.
The first prodisc C Vivo procedure was performed in Dallas-Fort Worth, TX by orthopedic spine surgeon Jason Tinley, MD, founder of DFW Center for Spinal Disorders.
ACCORDING TO DR. JASON TINLEY
DFW Center for Spinal Disorders, Dallas-Fort Worth, TX:
“This patient had severe left-sided neck pain radiating into the forearm and thumb and a left C5/6 disc herniation. Having the intraoperative options of a convex dome with spikes (prodisc C Vivo) versus a flat endplate component with keel (prodisc C) gave me the modularity to maximize endplate contact and stability, thus decreasing bone removal, risk of heterotopic ossification, subsidence, or implant failure. Ultimately, this allows me to best restore motion while also minimizing risk.”
Centinel Spine CEO Steve Murray stated, “This is a historic milestone for the company, and we appreciate the support from our surgeon partners. Total disc replacement is one of the fastest growing global segments in all of orthopedics, and we continue innovating in this area to advance patient care. With our recent regulatory achievements, we are now able to offer surgeons a unique range of options to match the disc to patient anatomy.”
The prodisc C Vivo system has been in clinical use internationally since 2009 and is currently one of the most frequently implanted TDR devices outside of the U.S. The device has keel-less fixation and combines a unique anatomically-designed superior endplate with lateral spikes to optimize fit and provide immediate fixation. Similar to all prodisc products, the prodisc C Vivo device incorporates prodisc CORE technology, the basis behind the predictable clinical outcomes of the prodisc platform after 30 years and over 225,000 implantations worldwide*.
* Data on file
About Centinel Spine, LLC
Centinel Spine®, LLC is a leading global medical device company addressing cervical and lumbar spinal disease through anterior surgical access. 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 technology platforms in the world for total disc replacement (prodisc®) and Integrated Interbody™ fusion (STALIF®).
Centinel Spine continues to advance its pioneering culture and corporate mission to become a catalyst of change in the spine industry and alter the way spine surgery is perceived. Centinel Spine remains the only company with comprehensive motion-preserving and fusion solutions for both cervical and lumbar anterior column reconstruction.
For more information, please visit the company’s website at www.CentinelSpine.com or contact:
Chief Financial Officer
900 Airport Road, Suite 3B
West Chester, PA 19380