Spineart USA's Baguera C cervical disc prosthesis has marked its 100th surgery in combined single-level and two-level U.S. investigational device exemption clinical trials.
Baguera C is an investigational device designed to reconstruct the cervical disc after discectomy for symptomatic cervical disc disease, according to a Nov. 16 news release. The IDE trials are examining the safety and efficacy of the Baguera C disc compared to the Mobi-C cervical disc. Up to 300 patients at 30 study sites are planned to be enrolled.
Armen Khachatryan, MD, of the Disc Replacement Center in Salt Lake City, is the leading enroller for the single-level trial. Hyun Bae, MD, of the Foundation for Spinal Restoration in Santa Monica, Calif., is the leading enroller of the two-level trial.