FDA to review Medtronic spinal disc

FDA to review Medtronic spinal disc

	Published : Fri, 13 Jul 2007 17:31 By : Agencies Print this Story

WASHINGTON (AP) - 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 cost of implanting its device would be comparable.

FDA will ask a panel of outside experts on Tuesday whether the device should be approved, and whether Medtronic should be able to claim it represents an improvement over currently available options.

The Minneapolis-based company states the device is superior because it maintains patients' ability to turn their heads from side to side, something not possible after spinal fusion.

While company studies showed the disc to be 10 percent more effective than surgery, FDA reviewers say further analyses of the data show the device may not be that effective. About 15,000 people outside the U.S. have already been implanted with the device, according to Medtronic.

The Bryan disc is the second spinal device from Medtronic to go before FDA's panel of orthopedic experts in the last year.

In September, the panel voted unanimously for approval of a similar device from Medtronic made from stainless steel, though the agency has yet to issue a final decision. The panel said that the Prestige disc should not be labeled as superior to surgery. If FDA ultimately agrees with that assessment, some analysts say it will probably limit sales of the device.

Both the Prestige and Bryan discs are approved for use in Europe.

Medtronic, the largest medical device maker in the world, had revenues of $2.8 billion last year, with roughly 20 percent coming from sales of spinal devices.

Shares of Medtronic Inc. fell 64 cents, or 1.20 percent, Friday to $52.56.