Medtronic Wins Conditional Approval Recommendation

July 27, 2007

An FDA advisory committee voted 7-1 this month to recommend conditional approval of Medtronic’s Bryan Cervical Disc. The day before the committee meeting, the FDA approved the company’s Prestige Cervical Disc, the first artificial neck disc sold in the U.S., according to Medtronic.

The Orthopaedic and Rehabilitation Devices Advisory Panel met July 17 to discuss and vote on the Bryan device. Medtronic claimed that the Bryan is superior to cervical fusion, the current gold standard for degenerative disc disease, because it maintains patients’ ability to turn their heads from side to side and has a faster recovery time.

The panel recommended approval with conditions, including surgeon training, patient education and postapproval studies.