FDA panel sets review date for Medtronic's Bryan cervical disc implant:
This article was originally published in Clinica
Executive Summary
A US FDA advisory panel is to meet on July 17 2007 to review a second artificial cervical disc made by Medtronic, the company has reported. It will vote on whether or not to recommend that the agency approves the total disc replacement (TDR) system, called Bryan. The company's first cervical TDR product, Prestige, came before the FDA's orthopaedic and rehabilitation devices advisory panel last year, and was given a positive recommendation for approval; the FDA is expected to deliver a final verdict on the device this summer, Medtronic said. The FDA has yet to approve a cervical TDR, although lumber TDRs are already available in the US.