First Device to Treat Cervical Degenerative Disc Disease Approved by FDA

The U.S. Food and Drug Administration (FDA) has approved a new device, the first of its kind, to treat Cervical Degenerative Disc Disease.

Medtronic Sofamor Danek, based in Memphis, makes the Prestige Cervical Disc. The new device is the first artificial cervical disc for Cervical Degenerative Disc Disease.

The Cervical Degenerative Disc Disease is a common disorder of the cervical (neck) vertebrae and it causes neck and back pain. The most common cause of the Cervical Degenerative Disc Disease is aging. As the body ages the cervical discs loose the tissue that surrounds them, or dry out, and lose their ability to act as cushions between the vertebrae. This leads to chronic pain in the neck that radiate to the shoulders and to the back of the patient.

Treatment of this condition is usually non-surgical with a combination of medication and physical therapy. However, when there is no relieve of pain for 3-4 months surgical options are recommended.

With today's approval of the new Prestige Cervical Disc there is an alternative option in the treatment of Cervical Degenerative Disc Disease. The device is an ingenious one. It is made of consists of two pieces of stainless steel that fit each one with a ball and trough (groove). The surgery consists of removal of the affected cervical disk and implantation of the Prestige Cervical device by screwing it to the other neck bones (vertebrae).

The U.S. Food and Drug Administration has a complex process for approval and registration of devices such as the one approved today. It is a process based on risk evaluation. After a complete evaluation of many factors a risk is established for the device and the approved if conditions are met. Requirements include high quality and productions standards, good manufacturing practices (GMP), good laboratory practices (GLP), and market follow-up for possible adverse reactions or conditions developed after the device is used. Under this risk evaluation risk three categories are possible: low-risk (class I), moderate-risk (class II), or high-risk (class III).