The clinical trial evaluated the safety and effectiveness of prodrive C Vivo and prodisc C SK system by comparing it to an approved total disc replacement (TDR) product as a check for 2-level indications.This is the first IDE study to allow surgeons to choose from two different TDR devices to treat each surgical level separately.The IDE trial involved 431 subjects at 29 locations in the United States.
WEST CHESTER, Pa., Oct. 26, 2023 /PRNewswire/ — Centinel Spine®LLC, (“the Company”), the leading global medical device company addressing cervical and lumbar spine diseases with the world’s most clinically proven total disc replacement (TDR) technology platform (prodisk®), today announced that the Food and Drug Administration (FDA) has accepted the submission of its Premarket Approval (PMA) application submitted for the Investigational Device Exemption (IDE) study evaluating the company’s benefitsdrive C I’m alive and prodisk C SK cervical TDR system. The filing date for the company’s PMA application was September 27, 2023, and the submission is now under substantive review by the FDA.
The prospective, randomized clinical trial was designed to evaluate the safety and effectiveness of the prodrive C I’m alive and prodisk C SK system by comparing it to an approved TDR product as a control for 2-level indications, making it the first and only trial of its kind with two investigational devices and a TDR control. The study completed enrollment in June 2023 and included 431 subjects at 29 US sites and allowed surgeons to select the study device: the prodrive C I’m alive and/or prodisk C S.K—based on patient anatomy, as well as other surgical factors. The ability to individually treat each level of disease at two levels provides surgeons with both more options and opportunities to tailor the intervertebral disc to the patient’s anatomical needs.
One of the lead investigators in the study, orthopedic spine surgeon Dr. Brian Perri of DOCS Health in Los Angeles, CA, commented on this important milestone: “Centinel Spine is once again working to demonstrate innovation, safety and effectiveness in their line of cervical disc replacements through this unique study. I hope for FDA approval soon, which will make Centinel Spine the first company to offer multiple disc designs for two-level procedures and allow the surgeon to select the best cervical total disc replacement for each level treated.
“The proffesionaldisk C Alive and prodisk C SK The 2-level cervical disc clinical trial was unique in two respects,” said Steve Murray, CEO of Centinel Spine. “It is the first cervical study to use total disc replacement devices in both study arms, and it is the only study to offer disc options in the study arm according to surgeon preference based on patient anatomy. This trial is in line with Centinel Spine’s strategy to be the only company providing both cervical and lumbar intraoperative prostate products.disk options for one- and two-level total drive replacement procedures. We look forward to the FDA’s careful review of the PMA submission.”
The proffesionaldrive C I’m alive system has been in clinical use internationally since 2009 and is currently one of the most implanted TDR devices in the world. The device has a keelless fixation and combines a unique anatomically designed superior endplate with lateral spikes to optimize fit and provide immediate fixation. The proffesionaldisk C SK The device features a flat end plate designed for optimized implant positioning, allowing surgeons to explore the individual patient’s anatomy – with a low-profile central keel that provides immediate fixation and allows for a streamlined keel preparation technique.
More information about the clinical trial can be found at www.clinicaltrials.gov using the identifier NCT04012996.
About Centinel Spine, LLC
Centinel spine®LLC is the leading global medical device company addressing cervical and lumbar spine diseases with the world’s most clinically proven total disc replacement (TDR) technology platform (prodisk®). The company’s prodisk technology is the most studied and clinically proven TDR system in the world, validated by more than 540 published articles and more than 250,000 implantations worldwide.
Centinel Spine continues to advance its pioneering culture and corporate mission to become a catalyst for change in the spine industry and change the way spine surgery is experienced. The proffesionaldisk platform remains the only technology with multiple motion preservation solutions for both cervical and lumbar anterior column reconstruction.
For more information, please visit the company’s website at www.CentinelSpine.com or contact:
Varun Gandhi
Finance Director
900 Airport Road, Suite 3B
West Chester, PA 19380
Phone: 484-887-8871
Email: v.gandhi@centinelspine.com
SOURCE Centinel Spine, LLC