Centinel Spine, LLC, the leading global medical device company addressing cervical and lumbar spinal disease with the most clinically-proven total disc replacement (TDR) technology platform in the world, announced that the Food and Drug Administration (FDA) has accepted the filing of its Premarket Approval (PMA) application submitted for the Investigational Device Exemption (IDE) study evaluating the Company’s prodisc C Vivo and prodisc 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 prodisc C Vivo and prodisc C SK system by comparing it with 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 sites throughout the U.S. and permitted surgeons to select the investigational device—the prodisc C Vivo and/or prodisc C SK—based on the patient’s anatomy, as well as other surgical factors. The ability to individually treat each level of two-level disease provides surgeons with both increased options and opportunities to match the disc to a patient’s anatomical needs.
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One of the lead investigators in the study, orthopedic spine surgeon Dr. Brian Perri from 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—making Centinel Spine the first company to offer multiple disc designs for two-level procedures and allowing the surgeon to select the best cervical total disc replacement for each level treated.”
“The prodisc C Vivo and prodisc C SK 2-level cervical disc clinical trial was unique in two ways,” said Centinel Spine CEO Steve Murray. “It is the first cervical trial to have total disc replacement devices in both study arms, and it is the only trial offering disc options in the investigational arm according to surgeon preference based on the patient anatomy. This trial is in line with Centinel Spine’s strategy to be the only company to provide both cervical and lumbar intraoperative prodisc options for one- and two-level total disc replacement procedures. We look forward to the FDA’s diligent review of the PMA submission.”
SOURCE : PRNewswire