Centinel Spine received FDA premarket approval Oct. 14 for two-level use of its prodisc C Vivo and prodisc C SK cervical disc replacement devices.
The decision is based on a 480-patient clinical study conducted at 31 U.S. sites — the largest to support a PMA for a cervical TDR device to date, according to an Oct. 14 news release from the device maker.
The two implants showed non-inferior outcomes compared to an approved control device and achieved a composite clinical success rate of 87.1%, the highest reported for an approved cervical system at two levels.
The approval allows surgeons to match implant design to patient anatomy. The prodisc C Vivo uses a keel-less design with lateral spikes, while the C SK features a flat endplate with a low-profile central keel.
Nearly 20,000 of the devices have been implanted in the U.S. since they were cleared for one-level use in 2022. Both incorporate Centinel Spine’s prodisc CORE technology, which has been used in more than 275,000 procedures worldwide.
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