Medtronic, Inc. announced that the Bryan Cervical Disc has received a recommendation for approval from the US Food and Drug Administration's (FDA) Orthopedic and Rehabilitation Devices advisory panel.
The panel recommended a variety of conditions that will be considered by the FDA during its ongoing review process.
The panel's decision was based in part on a successfully conducted prospective, randomized controlled clinical trial that showed substantial improvements in several major outcome measures of the study. The panel's recommendation will next be considered by the FDA in its review of the Premarket Approval (PMA) application for the implant. Upon final FDA approval of the PMA application, the Bryan Cervical Disc will be available to patients in the United States.
Analysis of the primary data set was presented to the panel demonstrating that Medtronic's Bryan Cervical Disc achieved statistical superiority in the composite outcome measurement of "overall success" when compared to the traditional fusion control. However, today's panel was reluctant to support a labelling claim of clinical "superiority" based on the analysis presented.
"The panel's decision helps bring us one step closer to being able to offer our patients this important therapy option," said Rick C. Sasso, M.D., of the Indiana Spine Group in Indianapolis. "Motion preservation is extremely important to many active patients and the Bryan Cervical Disc was shown to maintain motion at the treated level. Most importantly the panel recognized that the rigorous clinical study of the device supported that it is safe and effective for its intended use."
The panel recommendation comes on the heels of FDA approval of Medtronic's Prestige Cervical Disc, the first artificial cervical disc approved by the FDA.
The Bryan Cervical Disc, composed of a polyurethane nucleus surrounded by titanium endplates, is designed to replicate normal, physiologic motion of the cervical spine in patients suffering from degenerative disc disease (DDD) in the neck, as defined by the study protocol. The surgical procedure to implant the Bryan Cervical Disc is designed to relieve pressure on nerve roots and the spinal cord which helps alleviate neck and or arm pain.
The Bryan Cervical Disc underwent a multi-centred prospective, randomized, controlled, clinical trial to assess the safety and effectiveness based on comparisons between data collected from skeletally mature patients with single level symptomatic cervical DDD at one level between C3-C7. Cervical DDD was defined in the protocol as a combination of the following: disc herniation with radiculopathy, spondylotic radiculopathy, disc herniation with myelopathy, or spondylotic myelopathy. 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 cervical decompression and fusion procedure with allograft and plate stabilization.