FDA Approves New Treatment for Cervical Degenerative Disc Disease

The Food and Drug Administration recently approved a new surgical procedure for the treatment of cervical degenerative disc disease.

The cervical or neck region of the spine contains seven bones known as vertebrae, separated by intervertebral discs. The intervertebral discs allow the neck to rotate and to bend. Sometimes cervical degenerative disc disease can be provoked by aging bodies alone. Other times the condition is brought about by a twisting or falling injury. Cervical degenerative disc disease is the most common cause of neck and arm pain. Individuals with this condition may also experience numbness, weakness, and/or tingling in the neck, shoulders, and arms.

The surgical procedure used to treat cervical degenerative disc disease is a process by which surgeons remove the damaged or bulging disc and fuse two vertebrae together.

The recent approval of this new surgical procedure by the Food and Drug Administration would allow surgeons to replace the disc with the Prestige Cervical Disc, which acts as another intervertebral disc. The replacement disc is screwed to the adjacent vertebrae with bone screws.

The FDA based its approval for the Prestige Cervical Disc on animal testing and a clinical study done by Medtronic Sofamor Danek in Memphis, the manufacturer of this product. The clinical study consisted of 541 participants, and found that the Prestige Cervical Disc is as effective and safe as the fusion of two cervical vertebrae. The results of the study also indicate that the Prestige Cervical Disc reduced neck and arm pain.

While the FDA approved this device for the treatment of cervical degenerative disc disease, the FDA classified this product as class III, high-risk. The Food and Drug Administration bases all its medical device approvals on risk, with a device classified in class III as high-risk, class II as moderate-risk, and class I as low-risk.

As a condition of the FDA's approval, Medtronic Sofamor Danek has agreed to conduct post-approval studies, determining the long-term effectiveness and safety of the Prestige Cervical Disc.