A Medical Device Daily
NuVasive (SAN DIEGO) reported the first-in-human use in the U.S. of its NeoDisc cervical disc replacement device. Randall Dryer, MD, treated the first patient at the Central Texas Spine Institute (Austin, Texas), on Sept. 15.
The procedure was part of a multicenter clinical trial to evaluate the safety and efficacy of NeoDisc by comparing the outcomes of patients to traditional anterior cervical discectomy and fusion. The company said the implantation comes ahead of its guidance to begin enrollment by the fourth quarter.
The trial includes about 500 patients across 20 clinical investigation sites. The company's Gradient Plus cervical plate in a fusion procedure will serve as the control arm. Enrollment is estimated to be completed in 12-18 months.
Dryer said, “The procedure is extremely straightforward and will be familiar to any surgeon who has performed cervical fusion. I am pleased to say that the patient recovered rapidly from the procedure and was discharged after an overnight stay.”
When compared to a traditional cervical fusion with anterior plating, Dryer said, “The procedure can be performed more quickly because it requires less technical steps.”
NeoDisc is designed to treat patients earlier in the degenerative cascade, prior to a fusion procedure, and is designed to replace a degenerative cervical disc nucleus, partial annulus and anterior longitudinal ligament, while maintaining range of motion and leaving the natural vertebral endplates intact. Its design features an embroidered polyester jacket around a silicone core, with fixation flanges.