Orthopedic medical device developer Synergy Spine Solutions has enrolled the first patient in its 2-Level Investigational Device Exemption trial for the Synergy Disc artificial cervical disc, according to a June 29 news release.
The trial will assess the disc's safety and effectiveness for treating degenerative disc disease in patients with symptomatic conditions at two adjacent vertebral levels from C3 to C7, according to the release.
The study will involve 200 patients across up to 25 sites and will follow a multi-center, prospective, non-randomized, historically controlled design. All patients will receive the Synergy Disc and will be evaluated preoperatively, during surgery, immediately after surgery, and up to 24 months post-surgery.