Centinel Spine finished enrollment for a 2-level Investigational Device Exemption trial for the Prodisc C Vivo and Prodisc C SK disc replacement devices, the company said June 13.
The trial will include 431 patients across 29 sites in the U.S., according to a news release. The IDE trial is the first to allow surgeons to select from two different disc replacement devices to treat each level.
"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," Centinel Spine CEO Steve Murray said in the release.