FDA will ask about Medtronic spinal disc
Jul. 13, 2007

Federal regulators will ask outside medical experts next week whether implanting an artificial spinal disc made by Medtronic is more effective than surgery at treating certain neck injuries. The Food and Drug Administration said in documents posted online that Medtronic's Bryan implant is just as effective as the current surgical procedure for treating worn out spinal discs. But agency reviewers said it is unclear whether the titanium-coated plastic disc is superior to the spinal fusion procedure, in which a surgeon removes the damaged disc and brings together the surrounding vertebrae. Roughly 200,000 people in the U.S. undergo spinal fusion surgery each year, at an average cost of about $34,000, according to an article in the New England Journal of Medicine. Medtronic said the total cost of implanting its device would be comparable.

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