The U.S. Food and Drug Administration (FDA) has approved 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 brand approved, the Prestige Cervical Disc, is manufactured by Medtronic Sofamor Danek of Memphis.
"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, director, Center for Devices and Radiological Health, FDA. "This device will help relieve pain and restore function."
Cervical disc degeneration is a common cause of neck and arm pain that can greatly impact quality of life. The disc is a flexible material between the vertebrae that holds the bones together while still allowing for movement.
Because of the demands put on the disc, it sometimes can 'herniate' or wear down causing pain.
If treatments, such as rest, medications, physical therapy and activity modification are not successful, the standard surgical treatment is to remove the disc and then use a graft of bone and plate with screws to fuse the two vertebrae together.
The Prestige Cervical Disc would instead replace the impaired natural disc. It consists of two main pieces of stainless steel that articulate against one another with a ball and trough (groove). 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.
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.