Medtronic announced yesterday that the company received conditional FDA approval for its Prestige® Cervical Disc, the first cervical disc to be marketed in the U.S. Approval is contingent upon a seven-year post-approval study to evaluate long-term safety and effectiveness. The company will also perform a five-year enhanced surveillance study.
The news follows a unanimous approval recommendation from the FDA Orthopedic and Rehabilitation Devices advisory panel back in September of last year. At that time the Panel concluded the device was as effective as, not superior to, fusion. It is not clear from Medtronic's latest press release if there were any superiority claims in Prestige's label, but the Company claims to have clinical evidence demonstrating superiority in neurological success as well as "overall success."
Medtronic is also awaiting news on its other cervical disc in development, the BRYAN. An FDA panel will review the device today. Documents posted to the FDA website last week suggested that the panel is likely to recommend the device as equally effective to fusion, but claims of superiority may not be as easy to come by.
Whether these cervical devices will garner support from payors is yet to be seen. Back in May CMS published a proposal denying coverage for all lumbar artificial discs in the age 60-and-over Medicare population. The question still remains as to whether the supporting clinical and economic evidence for cervical discs can create a compelling coverage story.
