The trial is designed to guage the protection and effectiveness of the professionaldisc C Vivo and professionaldisc C SK system by evaluating it with an authorised whole disc substitute (TDR) product as a management for 2-level indications.
The trial provides surgeons the distinctive alternative to decide on the disc that most closely fits the affected person’s anatomy.
The two-level professionaldisc C Vivo and professionaldisc C SK trial enrolled 431 Topics at 29 websites throughout america.
WEST CHESTER, Pa., June 13, 2023 /PRNewswire/ — Centinel Backbone®, LLC, (“the Firm”) a number one international medical gadget firm addressing cervical and lumbar spinal illness by offering probably the most sturdy and clinically-proven whole disc substitute know-how platform on the planet (professionaldisc®), right now introduced the completion of enrollment in a first-of-its-kind Investigational System Exemption (IDE) research evaluating the Firm’s professionaldisc C Vivo and professionaldisc C SK cervical Whole Disc Substitute (TDR) system. That is the primary IDE trial permitting surgeons to pick out from two completely different TDR management units to deal with every surgical degree individually.
The potential, randomized medical trial is designed to guage the protection and effectiveness of the professionaldisc C Vivo and professionaldisc C SK system by evaluating it with an authorised TDR product as a management for 2-level indications, making it the primary and solely of its variety with two investigational units and a TDR management. The research contains 431 Topics at 29 websites all through the U.S. and with oversight from the U.S. Food and Drug Administration. The research permits surgeons to pick out the investigational gadget—the professionaldisc C Vivo and/or professionaldisc CSK—based mostly on the affected person’s anatomy, in addition to different surgical components. The flexibility to deal with every degree of two-level illness individually offers surgeons with each elevated choices and alternatives to match the disc to every affected person’s anatomical wants.
Orthopedic spine surgeon Jason Tinley, MD, founding father of the DFW Heart for Spinal Issues in Dallas-Fort Value, Texas, commented, “Every of my sufferers is exclusive of their cervical spine operative signs and anatomy. This IDE research was the primary ever to guage the protection and efficacy of a number of whole disc substitute units that empower surgeons to tailor their surgical answer to the affected person’s wants. I’ve discovered that professionaldiscC Vivo and professionaldisc C SK present a robust means to customise my surgical remedy to every affected person.”
The professionaldisc C Vivo system has been in medical use internationally since 2009 and is at the moment probably the most regularly implanted TDR units on the planet. The gadget has keel-less fixation and combines a novel anatomically-designed superior endplate with lateral spikes to optimize match and supply quick fixation. The professionaldisc C SK gadget contains a flat endplate designed for optimized implant positioning that permits surgeons to deal with particular person affected person anatomy—with a low-profile central keel that gives quick fixation and permits a streamlined keel preparation approach.
In accordance with Pierce Nunley, orthopedic spine surgeon at Specialists Hospital of Shreveport, Shreveport, Louisiana, “In 25 years of analysis this was the one FDA research I’ve ever been in the place I obtained to decide on intraoperatively between two completely different research units. This can be a distinctive facet of this research and we’re studying that ‘one measurement doesn’t match all’ and the place it’s extra acceptable to make use of completely different designs of a tool. This research will assist advance and enhance cervical disc substitute surgical procedure for the advantage of our sufferers.”
“That is the primary research ever to check two completely different spinal units to an authorised TDR product, making it a novel alternative to increase Centinel Backbone’s Match-the-Disc™ cervical whole disc substitute system to the remedy of two-level illness,” mentioned Centinel Backbone CEO Steve Murray. “The continued adoption of this cervical whole disc substitute know-how at one-level propelled Centinel Backbone to report revenues and a high market place within the first quarter of 2023. We look ahead to additional increasing the physique of medical proof supporting this method and to enabling extra surgeons to deal with every affected person’s distinctive wants.”
Extra details about the medical trial will be discovered at www.clinicaltrials.gov utilizing the identifier NCT04012996.
About Centinel Backbone, LLC
Centinel Backbone®, LLC is a number one international medical gadget firm addressing cervical and lumbar spinal illness via anterior surgical entry. The Firm gives a continuum of trusted, brand-name options backed by over 30 years of medical success—offering probably the most sturdy and clinically-proven know-how platforms on the planet.
Centinel Backbone continues to advance its pioneering tradition and company mission to turn into a catalyst of change within the spine business and alter the way in which spine surgical procedure is perceived. Centinel Backbone’s professionaldisc platform stays the one know-how with a number of motion-preserving options for each cervical and lumbar anterior column reconstruction.
For extra data, 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 Telephone: 484-887-8871 Electronic mail: firstname.lastname@example.org