Centinel Spine announced Investigational Device Exemption approval from FDA to initiate a two-level clinical trial with prodisc® C Vivo and prodisc C SK anterior cervical total disc replacement devices (TDRs).
The two-level prospective, randomized study will evaluate the devices at multiple sites throughout the U.S., comparing them to an existing TDR currently approved by FDA for two-level indications to validate their safety and effectiveness.
prodisc C Vivo has been used ex-U.S. since 2009. prodisc C SK is a variation of prodisc C Nova, an implant used ex-U.S. since 2010.
prodisc C Vivo and prodisc C SK employ the same mechanism of action as the currently-marketed prodiscC implant that was granted premarket approval in 2007. Their principal difference lies in the way in which the devices interface with the vertebral body; the variations are intended to allow a better match of the implant to a patient's anatomy.
Source: Centinel Spine, LLC