Medtronic completes enrollment of Prestige LP Cervical Disc trial

By E. Janene Geiss

Philadelphia, Dec. 7 - Medtronic, Inc. announced Wednesday the completion of enrollment in the Prestige LP Cervical Disc clinical trial, Medtronic's third major artificial cervical (neck) disc trial designed to explore new technologies for the treatment of degenerative spine disease.

The information gathered from this trial will help support an application to the U.S. Food and Drug Administration for future commercial sale of the device in the United States, according to a company news release.

This multi-center clinical trial is being conducted to assess the safety and effectiveness of the disc in the treatment of symptomatic nerve root and/or spinal cord compression associated with degenerative disc disease, officials said.

Each patient enrolled in the study received the Prestige cervical disc, officials said, and are being evaluated by their surgeon at regular intervals for a minimum of two years following the surgery.

The disc is made from a new titanium ceramic composite material that has shown enhanced wear characteristics and improved imaging properties in laboratory testing. The device is available internationally in a variety of sizes to allow evaluating surgeons to closely match the patient's anatomy, officials said.

It is designed to maintain motion and flexibility while replacing a diseased disc that is removed from a patient's cervical spine. Currently, the most common form of surgery for treating cervical degenerative disc disease is cervical spine fusion. Approximately 200,000 cervical procedures are performed each year to relieve compression on the spinal cord or nerve root and to implant a metal plate to rigidly fuse the vertebrae together.

"The Prestige LP Cervical Disc is designed to allow the patient the potential to maintain motion at the treated spinal level," J. Kenneth Burkus, an orthopedic surgeon at the Hughston Clinic in Columbus, Ga., and a lead investigator for the study, said in the release. "Because they do not have to wait for fusion to take place, many patients may return to normal activities sooner and without restrictions, braces or collars."

Medtronic Sofamor Danek, based in Memphis, Tenn., is focused on advancing the treatment of spinal disorders.

Medtronic, Inc. is a Minneapolis medical technology company focused on alleviating pain and restoring health for patients.

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