TUESDAY, July 17, 2007 (HealthDay News) -- The Prestige Cervical Disc is the first artificial disc to be sanctioned by the U.S. Food and Drug Administration to treat degenerative disc disease of the neck, the agency said Tuesday in announcing the device's approval.
The neck region, medically called the cervical spine, consists of seven vertebrae that are separated from each other by intervertebral discs. These discs let the neck bend and rotate.
The current standard treatment for degenerative disc disease is a surgical procedure called cervical fusion to remove a diseased disc and to fuse the remaining portions together, the agency said. The Prestige product is meant to replace the disc that's been removed.
The product is manufactured by Medtronic Sofamor Danek of Memphis, Tenn. The FDA said it considered results from the company's clinical study of 541 people, which found the device improved neck and arm pain, and was as safe and effective as cervical fusion.
The company is required, as a condition of approval, to conduct a seven-year study of the device's long-term safety and effectiveness, the FDA said.
To learn more about the cervical spine, visit the American Association of Neurological Surgeons.