Friday, October 27, 2023
Centinel Spine®, LLC, a prominent global medical device company specializing in cervical and lumbar spinal disease solutions, has achieved a significant milestone. The Food and Drug Administration (FDA) has officially accepted their Premarket Approval (PMA) application. This application relates to an Investigational Device Exemption (IDE) study focused on evaluating the prodisc C Vivo and prodisc C SK cervical Total Disc Replacement (TDR) system.
The unique aspect of this prospective clinical trial is its comparison of these devices to an FDA-approved TDR product for 2-level indications. This study is the first of its kind, involving two investigational devices and a TDR control.
This comprehensive study, which concluded its enrollment in June 2023, comprised 431 subjects from 29 U.S. sites. Importantly, it granted surgeons the flexibility to select between the prodisc C Vivo and prodisc C SK based on individual patient anatomy and other surgical considerations. This tailored approach significantly broadens the treatment options for patients with two-level spinal conditions.
The prodisc C Vivo system, which has been in clinical use since 2009 and is widely recognized as one of the most frequently implanted TDR devices globally, boasts a keel-less fixation design. It combines a superior endplate with lateral spikes, ensuring an optimal fit and immediate fixation.
In parallel, the prodisc C SK device features a flat endplate that facilitates precise implant positioning. This allows surgeons to address each patient's unique anatomy. Additionally, the device incorporates a low-profile central keel for immediate fixation and a streamlined keel preparation technique, making it a valuable addition to Centinel Spine's innovative product portfolio.
Source: prnewswire.com
