The Orthopaedic and Rehabilitation Devices Panel (the Panel) met on Tuesday, July 17, 2007 at the Hilton Washington DC North/Gaithersburg located at 620 Perry Parkway in Gaithersburg, Maryland. The Panel met in order to provide advice and a recommendation on the approvability of the Premarket Approval (PMA) application submitted by Medtronic Sofamor Danek, Inc., for the Bryan Cervical Disc Prosthesis (P060023). This device is a novel cervical disc prosthesis composed of a polyurethane nucleus, titanium shells with porous coating and a polyurethane sheath. The Bryan Cervical Disc is indicated in skeletally mature patients with cervical degenerative disc disease (DDD) at one level from C3-C7.
The meeting began with the Chief of the Orthopedic Spine Devices Branch within the Division of General, Restorative and Neurological Devices giving the panel an update of orthopaedic-related PMA approvals, reclassification petitions, guidances and FDA staff changes since the last meeting. The sponsor and FDA presentations focused on pre-clinical testing and clinical data collected on the subject device. Pre-clinical data presented included wear, migration, expulsion and reliability test results. The clinical data were collected in a randomized, multi-center study intended to assess the safety and effectiveness of the Bryan Cervical Disc by demonstrating non-inferiority to a control spinal fusion treatment. Overall success consisted of a composite endpoint including: at least 15 points of improvement on the neck disability index (NDI); maintained/improved neurological status; no serious adverse events related to the surgery/device; and, no additional surgeries classified as a failure. The Bryan Cervical Disc study results were found to be non-inferior to the spinal fusion control out to 24 months.
The Panel voted (7-1-0) to recommend that the PMA application for the Bryan Cervical Disc be found “Approvable with Conditions.” The recommended conditions of approval are summarized as follows:
- There should be no mention of adjacent level motion or disease in product literature or labeling.
- A rabbit animal study should be performed on animals confirmed to be free of other conditions (e.g., protozoans), to investigate the effects of particulates on the kidneys.
- There should be no claim of superiority in the product literature or labeling.
- There should be appropriate training for surgeons.
- There should be appropriate patient education materials.
- The indications for use should be revised to: “The Bryan Cervical Disc is indicated for skeletally mature patients as an alternative for reconstruction following single level surgical decompression for radiculopathy or myelopathy between C3 and C7.”
- A postapproval study should be conducted out to 10 years, and should analyze effects on adjacent levels, heterotopic ossification and kyphosis. In addition, explant analysis should be conducted with 1 reviewing center.
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