The artificial cervical neck disc device is designed to be surgically inserted to replace the diseased disc from the cervical spine of the patient. The device helps patients maintain motion and flexibility and relieves pain.
According to the FDA, neck and arm pain is most commonly attributed to cervical degenerative disc disease.
According to the manufacturer, there are more than 200,000 cervical procedures performed annually to relieve the painful compression of the spinal cord or nerve root experienced by patients with this disease. The old procedure used to rigidly fuse the vertebrae together.
"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 of the Center for Devices and Radiological Health with the FDA.
"This device will help relieve pain and restore function," said Schultz.
The Prestige Cervical Disc device is mainly made out of stainless steel with a ball and groove action that is attached to where the diseased disk is removed by using bone screws.
Clinical studies were shown to be as safe and effective as the prior method of cervical fusion.
The FDA's Orthopedic and Rehabilitation Devices advisory panel unanimously recommended approval for the device back in September 2006.
The final approval requires the manufacturer to conduct a post-approval study in the following seven years. This study will be conducted to evaluate further long-term safety and effectiveness of the device, which the FDA will continue to monitor.
The FDA has approved the device with a class III category, which places it in the high-risk category and requires any adverse post-marketing events to be reported.
However, the alternative to surgical fusing is far outweighed by patients who are in excessive long-term pain who are willing to undergo a surgical procedure to insert this disc as a means of remedying this disease.
