Medtronic has announced that the FDA will be reviewing its Bryan® Cervical Disc System, an implant designed for surgical candidates suffering from cervical degenerative disc disease.
The press release gives an overview of the system:
The Bryan Cervical Disc is designed to alleviate pain and preserve motion and flexibility while replacing a diseased disc that is removed from a patient’s cervical spine. Traditionally, the most common form of surgery for treating cervical degenerative disc disease (DDD) is cervical spine fusion. More than 200,000 cervical procedures are performed each year to relieve compression on the spinal cord or nerve roots and to implant a metal plate to rigidly fuse the vertebrae together.
The Bryan Cervical Disc underwent a multi-center prospective, randomized, controlled, equivalency clinical trial to assess the safety and effectiveness based on comparisons between data collected from 463 skeletally mature patients with single level symptomatic cervical DDD at one level between C3-C7. The investigational group of 242 patients was implanted with the Bryan Cervical Disc, while the control group of 221 patients received a single level anterior interbody fusion procedure with allograft and plate stabilization.
The Bryan Cervical Disc underwent a multi-center prospective, randomized, controlled, equivalency clinical trial to assess the safety and effectiveness based on comparisons between data collected from 463 skeletally mature patients with single level symptomatic cervical DDD at one level between C3-C7. The investigational group of 242 patients was implanted with the Bryan Cervical Disc, while the control group of 221 patients received a single level anterior interbody fusion procedure with allograft and plate stabilization. Press release: Medtronic’s Bryan® Cervical Disc System to be Reviewed by FDA Panel …