FDA Advisers Endorse Steel Spinal Disks

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FDA Advisers Endorse Steel Spinal Disks

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WASHINGTON (AP) -- 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.

On the Net:

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

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