FDA Clearance Received For First Cervical Artificial Disc

Main Category: Neurology / Neuroscience
Also Included In: Medical Devices / Diagnostics;  Regulatory Affairs / Drug Approvals
Article Date: 29 Aug 2007 - 1:00 PDT

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People who have suffered for years from degenerative discs in their neck now have an option that may relieve the pain in their neck and arm, allow quick recovery and enable them to lead active and productive lives. On July 17, the Food and Drug Administration (FDA) cleared the Prestige ST Cervical Disc System.

Used extensively in Europe, FDA clearance of the Prestige disc from Medtronic follows a unanimous recommendation for approval from the FDA advisory board. The artificial disc for the cervical (neck) region is expected to impact more than 200,000 Americans who suffer from degenerative disc disease.

Currently, the most common treatment for patients with degenerative discs in the cervical spine is spinal fusion. In this procedure a surgeon removes the damaged disc then implants a bone graft and metal plate to fuse the vertebrae together. During artificial disc replacement surgery, the damaged disc is removed and replaced with an artificial disc, a stainless-steel device with a ball-in-trough design intended to allow for replication of normal motion. The disc stays in place with bone screws. The hospital stay for this procedure is approximately 1-2 days. Patients can begin rehabilitation and return to daily activities soon after surgery. In fact, patients receiving the Prestige ST artificial disc returned to work in 45 days, 16 days earlier than the fusion patients.

"Compared to spinal fusion, this surgery allows patients to maintain normal neck motion, and study has shown a lower rate of additional surgery for degeneration of adjacent segments," says Noam Stadlan, M.D., CINN neurosurgeon (CINN.org). "Unlike with fusion, patients who've received the disc don't have to bother with a hard collar following surgery."

"Study results show that artificial cervical disc patients regain function faster, and have a higher rate of neurological success as measured by muscle tone, strength, sensation, as well as responsiveness of reflexes than those who undergo spinal fusion," says Dr. Dean Karahalios, CINN neurosurgeon. "Furthermore, the study demonstrated that at two year follow-up the overall success rate for the artificial disc group was 79.3% compared to the fusion group at 67.8%. These reasons are compelling enough for potential candidates to consider the option of an artificial disc."

The Chicago Institute of Neurosurgery and Neuroresearch is one of the nation's leading organizations for the diagnosis, treatment and rehabilitation of people with brain and spine disorders. Originally founded in 1987, CINN is one of the Midwest's largest teams of neurosurgeons, physiatrists and neurologists known for their pioneering treatments in minimally invasive techniques. Through a network of seven hospitals throughout Chicagoland, CINN is a market leader in treating patients with brain tumors and spine disorders.

http://www.cinn.org
http://www.neuro-ortho.org