FDA Advisers Endorse Steel Spinal Disks

A stainless steel device meant to replace natural but diseased shock-absorbing disks in the neck should receive government approval, government health advisers said Tuesday.

The two-part device is meant as an alternative to spinal fusion surgery in patients suffering from degenerative disc disease. The manufacturer of the Prestige Cervical Disc System, Medtronic Inc., said its device can help maintain motion and flexibility in patients, while relieving pain.

The Food and Drug Administration's Orthopaedic and Rehabilitation Devices panel unanimously recommended the agency approve the device with conditions. The conditions include a requirement that Medtronic continue to study the device once it's on the market.

The FDA isn't required to follow the advice of its advisory committees, but it usually does.

An FDA review of the device found it just as safe and effective as the surgical fusing of vertebrae in the neck area of the spine. Panel members agreed Tuesday.

Medtronic designed the device to be surgically implanted between the bones that make up the spine, with its plates screwed into the vertebrae themselves. The ball-and-socket connection between the device's two plates allows limited movement.

If the device ultimately wins FDA approval, the Minneapolis company plans to sell the device in multiple sizes.

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On the Net:

Food and Drug Administration: http://www.fda.gov/

Medtronic Inc.: http://www.medtronic.com/