Centinel Backbone now has 4 PMA authorised cervical Whole Disc Alternative (TDR) units, providing the broadest spectrum of options to deal with surgeon choice and particular person affected person anatomy.
The number of cervical TDR endplate configurations, coupled with the confirmed and well-documented professionaldisc® CORE expertise, permits for optimization of implant match and surgical outcomes.
The newly authorised professionaldisc C Vivo and professionaldisc C Nova merchandise have in depth medical utilization outdoors of the U.S. since 2009.
The professionaldisc expertise is essentially the most studied and clinically-proven TDR system on this planet, validated by over 540 revealed papers.
WEST CHESTER, Pa., July 13, 2022 /PRNewswire/ — Centinel Backbone®, LLC, a number one international medical machine firm addressing cervical and lumbar spinal illness by means of anterior surgical entry, at present introduced U.S. Food and Drug Administration (FDA) Pre-Market Utility (PMA) Approval for 1-level indications for 3 further cervical whole disc substitute (TDR) units: professionaldiscC Vivo, professionaldiscC Nova, and professionaldiscC SK. Together with the presently out there professionaldiscC implant, which continues to be extensively used all through the U.S., Centinel Backbone now has the broadest providing of cervical TDR options on this planet to deal with surgeon choice and particular person affected person anatomy.
The TDR market is anticipated to stay the quickest development phase inside the backbone business, rising globally in extra of 11% CAGR and reaching $2.69B by 2026 (Synthetic Disc Market Insights, Aggressive Panorama and Market Forecast-2027, DelveInsight Enterprise Analysis LLP, 2022). The professionaldisc platform has been a pioneering TDR expertise and a serious contributor to this development with steady innovation over the previous 30 years. Centinel Backbone is the one firm providing a number of cervical TDR choices for surgeons to pick from based mostly on every affected person’s anatomy on the surgical stage.
The professionaldiscC Vivo and professionaldiscC Nova merchandise have been in use outdoors the U.S. since 2009, and professionaldiscC Vivo is presently essentially the most ceaselessly implanted TDR outdoors of the U.S. The professionaldiscCVivo product has keel-less endplates together with a convex, superior endplate to match extra concave vertebral anatomy, whereas the professionaldiscC SK and professionaldiscCNova implant designs have flat endplates with low-profile keels to raised match flat vertebral anatomy. All of those merchandise incorporate professionaldiscCORE expertise, the idea behind the predictable medical outcomes of each professionaldisc machine after 30 years and over 225,000 implantations, worldwide.
“The FDA approval of the professionaldisc C Vivo, Nova, and SK units provides the surgeon a brand new stage of modularity and stability for cervical disc substitute,” says Jason Tinley, MD, orthopedic backbone surgeon and founding father of DFW Middle for Spinal Issues in Dallas-Fort Value, TX. “The affected person can now obtain an implant that finest conforms to their anatomy intraoperatively, with variable endplate traits that finest swimsuit the surgeon’s choice of method,” Dr. Tinley provides.
Centinel Backbone’s CEO, Steve Murray, acknowledged, “Anatomic cervical whole disc choices present surgeons the good thing about choosing implants to optimally match the disc to every affected person. That is distinctive and represents a serious development in spinal reconstruction. PMA approval for these three further units is a major accomplishment and we sit up for bringing the brand new prodisc choices to the market in This autumn 2022.”
Centinel Backbone additionally continues to enroll for a two-level potential, randomized, multi-centered medical examine evaluating professionaldiscC Vivo and professionaldiscC SK.
About Centinel Backbone, LLC
Centinel Backbone®, LLC is a number one international medical machine firm addressing cervical and lumbar spinal illness by means of anterior surgical entry. The corporate provides a continuum of trusted, brand-name, motion-preserving and fusion options backed by over 30 years of medical success—offering essentially the most sturdy and clinically-proven expertise platforms on this planet for whole disc substitute (professionaldisc®) and Built-in Interbody™ fusion (STALIF®).
Centinel Backbone continues to advance its pioneering tradition and company mission to grow to be a catalyst of change within the backbone business and alter the way in which backbone surgical procedure is perceived. Centinel Backbone stays the one firm with complete motion-preserving and fusion options for each cervical and lumbar anterior column reconstruction.
For extra info, please go to the corporate’s web site at www.CentinelSpine.com or contact:
Varun Gandhi Chief Monetary Officer 900 Airport Highway, Suite 3B West Chester, PA 19380 Cellphone: 484-887-8871 E mail: email@example.com