US-based medical device company Centinel Spine has completed enrolment in the first investigational device exemption (IDE) study to evaluate two of its total disc replacement (TDR) devices.
Designed to evaluate the prodisc C Vivo and prodisc C SK cervical TDR system, the trial will extend Centinel Spine’s Match-the-Disc cervical TDR system to the treatment of two-level disease.
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Surgeons are able to select the prodisc C Vivo and/or prodisc C SK based on the patient’s anatomy, as well as other surgical factors. The randomised clinical trial will evaluate the safety and effectiveness of the two TDR systems by comparing them with an approved product as a control for two-level indications.
The ability to treat each level of two-level disease individually gives surgeons increased options and opportunities to match the disc to each patient’s anatomical needs. The study includes 431 subjects at 29 sites throughout the US and is being overseen by the US Food and Drug Administration (FDA).
The prodisc C Vivo system has been in international clinical use since 2009 and is one of the most frequently implanted TDR devices. The device has keel-less fixation and combines a unique anatomically designed endplate with lateral spikes to optimise fit and provide immediate fixation.
The prodisc C SK device has a flat endplate designed for optimised implant positioning, allowing surgeons to address individual patient anatomy. It has a low-profile central keel that provides immediate fixation and enables a streamlined keel preparation technique.
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By GlobalDataDFW Centre for Spinal Disorders founder and orthopaedic spine surgeon Jason Tinley commented; “Each of my patients is unique in their cervical spine operative symptoms and anatomy. I’ve found that prodisc C Vivo and prodisc C SK provide a powerful means to customise my surgical treatment to each patient.”
According to a report by GlobalData, the vertebral body replacement market size was valued at $356.7m in 2022. This is forecast to increase to $519.4m by 2033.
