Good News for People with Neck Disc Degenerative Disease

The U.S. Food and Drug Administration (FDA) announced in a press release that it has approved the Prestige Cervical Disc to treat one of the most common causes of neck and arm pain - cervical degenerative disc disease. The Prestige Cervical Disc can be used for current surgical treatment to remove a diseased or bulging disc in the patient's neck and for the fusion of two or more bony vertebrae. The Prestige Cervical Disc would replace the impaired natural disc.

Dr. Daniel Schultz, Director for the FDA Center for Devices and Radiological Health says, "The approval of this artificial disc means that people with cervical degenerative disc disease now will have another surgical option for treating this condition. This device will help relieve pain and restore function." The Prestige Cervical Disc is made by Medtronic Sofamor Danek of Memphis, Tennessee.

The cervical spine in the neck region consists of seven bones, or vertebrae, that are separated by intervertebral discs. Those discs allow the neck to bend and rotate, but can bulge and degenerate, causing severe pain when the bones rub against one another. The Prestige Cervical Disc is the first approved artificial medical device that consists of two main pieces of stainless steel that "articulate against one another with a ball and trough." After the doctor removes the degenerative or bulged disc, the artificial disc can be attached to the vertebrae with bone screws.

According to Spine-health.com, patients with cervical disc degeneration might experience numbness, tingling, and weakness in the neck, arms, or shoulders as a result of nerves in the neck area becoming irritated or pinched. A pinched nerve in the C6-C7 discs could result in arm weakness, wrist drop and altered sensation in fingers. Cervical disc degeneration can also contribute to spinal stenosis, and other progressive conditions, as well as sudden disc herniation. Surgery to replace and fuse neck discs and vertebrae have included the patient's choice of using a bone graft, usually from the hip or a replacement piece from a cadaver, along with a metal plate for fusion. Bone grafting, in itself, can be a painful, invasive procedure.

If the doctor determines that further testing is needed after a physical exam, then X-Rays, an MRI and possibly a CT scan will be taken. These diagnostic images can confirm if and where degeneration is occurring. They can also identify conditions such as calcification or arthritis, that could be causing the painful symptoms.

The clinical study of this device included the company's lab testing, animal testing, and testing with 541 patients. The FDA's approval was also based on recommendations of the Orthopedic and Rehabilitation Devices Panel of FDA's Medical Devices Advisory Committee. As a condition of the approval, the company must conduct a seven-year post-approval study to determine the longer term safety and effectiveness of the product. The FDA approved the Prestige Cervical Disc as a class III device, meaning there is high-risk of using the product during the pre-market approval process.

Sources:

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01668.html

http://www.spine-health.com/topics/cd/overview/cervical/cerv05.html