1st Artificial Cervical Disc Approved
FDA OKs the Prestige Cervical Disc as a Treatment for Cervical Degenerative Disc Disease
July 19, 2007 -- The FDA has approved the Prestige Cervical Disc, 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," says the FDA's Daniel Schultz, MD, in an FDA news release.
"This device will help relieve pain and restore function," says Schultz, who directs the FDA's Center for Devices and Radiological Health.
The cervical spine (neck region) consists of seven bones called vertebrae, which are separated from one another by intervertebral discs. These discs allow the neck to bend and rotate.
The current surgical treatment for cervical degenerative disc disease 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 disc consists of two main pieces of stainless steel that act as a joint with a ball and trough (groove). A surgeon removes the impaired natural disc and uses bone screws to attach the artificial disc to the adjacent vertebrae.
Prestige Cervical Disc's Approval
The FDA approved the Prestige Cervical Disc earlier this week based in part on a 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 surgical treatment for degenerative disc disease, according to the FDA.
The FDA also considered the recommendations of the Orthopedic and Rehabilitation Devices Panel of the FDA's Medical Devices Advisory Committee, which reviewed the artificial cervical disc in September.
As a condition of the disc's approval, Medtronic will study the device's safety and effectiveness over the next seven years. The FDA will continue to monitor the device as part of its overall effort to ensure that products remain safe and effective once they reach the marketplace.