Medtronic neck disc as good as fusion-US FDA staff

Fri Jul 13, 2007 11:05am EDT
 
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(Adds Medtronic, FDA staff comments, background)

WASHINGTON, July 13 (Reuters) - Medtronic Inc.'s (MDT.N) Bryan cervical disc worked as well as spinal fusion surgery for treating damaged discs in the neck, U.S. regulatory reviewers said in documents released on Friday.

Food and Drug Administration staff said a Medtronic study showed the Bryan disc was "non-inferior" to spinal fusion and potential risks from both treatments were similar.

The FDA released the staff analysis ahead of an advisory panel meeting on Tuesday to review the device. Outside experts on the panel are expected to vote on whether to recommend approval.

Spinal fusion surgery can relieve pain but restricts movement. Artificial discs are designed to replace diseased discs while preserving the ability to bend.

FDA reviewers said they may ask the advisory panel about how well the Bryan disc preserved motion, and whether data support Medtronic's claim that the overall success of the device proved superior to fusion.

Medtronic in a separate summary said the Bryan disc maintained motion at the treatment site, while movement in adjacent areas was similar to fusion. The Bryan disc "is as safe and effective as the current standard of care," the company said.

The Medtronic and FDA summaries were posted on the FDA Web site here.

((Reporting by Lisa Richwine, editing by Mark Porter; Reuters Messaging: lisa.richwine.reuters.com@reuters.net; +1 202 310-5691)) Keywords: MEDTRONIC DISC/

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