- The scientific trial evaluated the security and effectiveness of the professionaldisc C Vivo and professionaldisc C SK system by evaluating it with an permitted whole disc alternative (TDR) product as a management for 2-level indications.
- That is the primary IDE trial permitting surgeons to pick out from two completely different TDR gadgets to deal with every surgical stage individually.
- The IDE trial enrolled 431 Topics at 29 websites throughout the US.
WEST CHESTER, Pa., Oct. 26, 2023 /PRNewswire/ — Centinel Backbone®, LLC, (“the Firm”) the main world medical machine firm addressing cervical and lumbar spinal illness with probably the most clinically-proven whole disc alternative (TDR) expertise platform on this planet (professionaldisc®), as we speak introduced that the Food and Drug Administration (FDA) has accepted the submitting of its Premarket Approval (PMA) utility submitted for the Investigational Machine Exemption (IDE) research evaluating the Firm’s professionaldisc C Vivo and professionaldisc C SK cervical TDR system. The submitting date for the Firm’s PMA utility was September 27, 2023 and the submission is now underneath substantive assessment by the FDA.
The potential, randomized scientific trial was designed to judge the security and effectiveness of the professionaldisc C Vivo and professionaldisc C SK system by evaluating it with an permitted TDR product as a management for 2-level indications, making it the primary and solely trial of its form with two investigational gadgets and a TDR management. The research accomplished enrollment in June 2023 and included 431 Topics at 29 websites all through the U.S. and permitted surgeons to pick out the investigational machine—the professionaldisc C Vivo and/or professionaldisc C SK—based mostly on the affected person’s anatomy, in addition to different surgical components. The flexibility to individually deal with every stage of two-level illness supplies surgeons with each elevated choices and alternatives to match the disc to a affected person’s anatomical wants.
One of many lead investigators within the research, orthopedic spine surgeon Dr. Brian Perri from DOCS Health in Los Angeles, CA, commented on this necessary milestone, “Centinel Backbone is as soon as once more working to display innovation, security, and effectiveness of their line of cervical disc replacements by this distinctive research. I hope for FDA approval quickly—making Centinel Backbone the primary firm to supply a number of disc designs for two-level procedures and permitting the surgeon to pick out the very best cervical whole disc alternative for every stage handled.”
“The professionaldisc C Vivo and professionaldisc C SK 2-level cervical disc scientific trial was distinctive in two methods,” stated Centinel Backbone CEO Steve Murray. “It’s the first cervical trial to have whole disc alternative gadgets in each research arms, and it’s the solely trial providing disc choices within the investigational arm based on surgeon desire based mostly on the affected person anatomy. This trial is consistent with Centinel Backbone’s technique to be the one firm to offer each cervical and lumbar intraoperative professionaldisc choices for one- and two-level whole disc alternative procedures. We look ahead to the FDA’s diligent assessment of the PMA submission.”
The professionaldisc C Vivo system has been in scientific use internationally since 2009 and is at the moment one of the crucial continuously implanted TDR gadgets on this planet. The machine has keel-less fixation and combines a singular anatomically-designed superior endplate with lateral spikes to optimize match and supply rapid fixation. The professionaldisc C SK machine encompasses a flat endplate designed for optimized implant positioning that enables surgeons to handle particular person affected person anatomy—with a low-profile central keel that gives rapid fixation and allows a streamlined keel preparation approach.
Extra details about the scientific trial could be discovered at www.clinicaltrials.gov utilizing the identifier NCT04012996.
About Centinel Backbone, LLC
Centinel Backbone®, LLC is the main world medical machine firm addressing cervical and lumbar spinal illness with probably the most clinically-proven whole disc alternative (TDR) expertise platform on this planet (professionaldisc®). The Firm’s professionaldisc expertise is probably the most studied and clinically-proven TDR system throughout the globe, validated by over 540 revealed papers and greater than 250,000 implantations worldwide.
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. The professionaldisc platform stays the one expertise 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:
Chief Monetary Officer
900 Airport Highway, Suite 3B
West Chester, PA 19380
Electronic mail: firstname.lastname@example.org
SOURCE Centinel Backbone, LLC