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U.S. Department of Health and Human Services

Advisory Committees

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Orthopaedic and Rehabilitation Devices Panel - July 17, 2007

  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:

  1. There should be no mention of adjacent level motion or disease in product literature or labeling.
  2. 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.
  3. There should be no claim of superiority in the product literature or labeling.
  4. There should be appropriate training for surgeons.
  5. There should be appropriate patient education materials.
  6. 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.”
  7. 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.

Contact: Ronald P. Jean, Ph.D., Executive Secretary, at 240-276-3676 or ronald.jean@fda.hhs.gov.

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