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To treat one of the most common causes of neck and arm pain--cervical degenerative disc disease--FDA approved on July 17, 2007, the first artificial cervical disc.
The PRESTIGE Cervical Disc, made by Medtronic Sofamor Danek of Memphis, will give people with the disease another surgical treatment option, says Daniel Schultz, M.D., Director of FDA's Center for Devices and Radiological Health. “This device will help relieve pain and restore function,” he says.
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.
Cervical degenerative disc disease is currently treated by removing a diseased or bulging disc in a patient's neck and fusing two or more bony vertebrae. The new artificial disc can instead replace the impaired natural disc. After a doctor removes the impaired disc, the artificial disc is attached to the adjacent vertebrae with bone screws.
As a condition of approval, the company will evaluate the device's longer term safety and effectiveness over the next seven years. FDA will continue to monitor the disc as part of its effort to ensure that products remain safe and effective once they reach the marketplace.
To see the PRESTIGE Cervical Disc: http://www.fda.gov/cdrh/pdf6/p060018.jpg .
FDA Press Release (July 17, 2007)
Date Posted: July 18, 2007
