Synergy Disc Replacement has enrolled the first patient in its U.S. Investigational Device Exemption clinical trial. The multicenter, prospective, historically controlled study will be conducted on 175 patients at up to 15 U.S. sites, seeking to demonstrate that the Synergy Disc® device is at least as safe and effective as conventional anterior cervical discectomy and fusion in patients with one-level symptomatic cervical degenerative disc disease.
Synergy Disc is reportedly the first company to provide a physiological center of rotation inflexion and extension, as well as lateral bending and axial rotation.
The Synergy Disc and has been issued more than 55 patents protecting its novel design elements and features of alignment and motion restoration. The company has applied for a CE Mark and has commercialized the technology in select countries in Europe and Australia.