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FDA NEWS RELEASE

FOR IMMEDIATE RELEASE
July 17, 2007

Media Inquiries:
Kris Mejia, 301-827-6242
Consumer Inquiries:
888-INFO-FDA


FDA Approves First of a Kind Medical Device to Treat Cervical Degenerative Disc Disease

The U.S. Food and Drug Administration (FDA) approved for marketing the Prestige Cervical Disc, made by Medtronic Sofamor Danek of Memphis — the first artificial cervical (neck) disc for the treatment of cervical degenerative disc disease, one of the most common causes of neck and arm pain.

"The approval of this artificial disc means that people with cervical degenerative disc disease now will have another surgical option for treating this condition," said Daniel Schultz, M.D., director, Center for Devices and Radiological Health, FDA. "This device will help relieve pain and restore function."

The cervical spine (neck region) consists of seven bones (called the vertebrae), which are separated from one another by intervertebral discs. These discs allow the neck to bend and rotate.

The current surgical treatment involves removing a diseased or bulging disc in a patient's neck and fusing two or more bony vertebrae. The Prestige Cervical Disc would instead replace the impaired natural disc.

The PRESTIGE Cervical Disc consists of two main pieces of stainless steel that articulate against one another with a ball and trough (groove) http://www.fda.gov/cdrh/pdf6/p060018.jpg. After a doctor removes the impaired natural disc, the artificial disc is attached to the adjacent vertebrae with bone screws.

FDA based approval on the company's laboratory and animal testing, and on its clinical study of 541 patients. The clinical study showed that the device improved neck and/or arm pain, and was as safe and effective as cervical fusion, a common treatment for degenerative disc disease. The approval decision also took into account the recommendations of the Orthopedic and Rehabilitation Devices Panel of FDA's Medical Devices Advisory Committee, which reviewed the product in September.

As a condition of approval, the company will conduct a post-approval study over the next seven years to evaluate the longer term safety and effectiveness of the device. FDA will continue to monitor the device as part of the agency's overall effort to ensure that products remain safe and effective once they reach the marketplace.

FDA approved the PRESTIGE Cervical Disc as a class III device under the pre-market approval process. FDA's regulation of medical devices is risk-based, with devices classified into low-risk (class I), moderate-risk (class II), or high-risk (class III) categories. The FDA regulatory program includes requirements for registration and listing of products, for high-quality production using good manufacturing practices and for post-market reporting of adverse events.

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