Centinel Spine Finishes Enrollment in prodisc C IDE Trial

Centinel Spine has completed enrollment in an investigational device exemption (IDE) study evaluating its prodisc C Vivo and prodisc C SK cervical total disc replacement (TDR) system. According to Centinel, it’s the first IDE trial that allows surgeons to choose from two different TDR control devices to treat each surgical level individually.
 
The trial is evaluating safety and effectiveness of prodisc C Vivo and prodisc C SK by comparing it with another approved TDR as a control for 2-level indications. 431 subjects are being evaluated at 29 U.S. sites with oversight from the FDA.
 
The study allows surgeons to choose the prodisc C Vivo and/or prodisc C SK based on the patient’s anatomy and other factors. Treating each level of two-level disease individually provides increased options and opportunities to match the disc to anatomical needs.
 
Orthopedic spine surgeon Jason Tinley, MD, founder of the DFW Center for Spinal Disorders in Dallas-Fort Worth, Texas, told the press, “Each of my patients is unique in their cervical spine operative symptoms and anatomy. This IDE study was the first ever to evaluate the safety and efficacy of multiple total disc replacement devices that empower surgeons to tailor their surgical solution to the patient’s needs. I’ve found that prodisc C Vivo and prodisc C SK provide a powerful means to customize my surgical treatment to each patient.”
 
prodisc C Vivo has been used internationally since 2009, and according to Centinel is one of the most frequently implanted TDR devices in the world. It has keel-less fixation and combines an anatomically designed superior endplate with lateral spikes. prodisc C SK has a flat endplate to optimize positioning so individual patient anatomy can be addressed, as well as a low-profile central keel for immediate fixation and streamlined keep preparation technique.
 
According to Pierce Nunley, orthopedic spine surgeon at Specialists Hospital of Shreveport, Shreveport, La., “In 25 years of research this was the only FDA study I have ever been in where I got to choose intraoperatively between two different study devices. This is a unique aspect of this study and we are learning that ‘one size doesn’t fit all’ and where it is more appropriate to use different designs of a device. This study will help advance and improve cervical disc replacement surgery for the benefit of our patients.”
 
“This is the first study ever to compare two different spinal devices to an approved TDR product, making it a unique opportunity to extend Centinel Spine’s Match-the-Disc cervical total disc replacement system to the treatment of two-level disease,” said Centinel Spine CEO Steve Murray. “The continued adoption of this cervical total disc replacement technology at one-level propelled Centinel Spine to record revenues and a top market position in the first quarter of 2023. We look forward to further expanding the body of clinical evidence supporting this system and to enabling more surgeons to treat each patient’s unique needs.”