FDA Approves Medtronic's Prestige Cervical Disc, the First Artificial Disc for the Neck

According to Medtronic, Inc., they've received approval from the U.S. Food and Drug Administration (FDA) to market the Prestige® Cervical Disc which is the first artificial disc that has been created for the neck.

Individuals who suffer from degenerative disc disease which causes neck or arm pain can greatly benefit from receiving the Prestige® Cervical Disc.

Medtronic has agreed to conduct a seven-year study as part of the FDA approval. The study will evaluate the long term effectiveness and safety of the Prestige® Cervical Disc. In addition, Medtronic will conduct a five-year study.

According to the Chief of Neurosurgery and Director of Neurosciences at Baptist Hospital in Miami, Dr. Sergio Gonzalez-Arias, the Prestige® Cervical Disc is designed to allow motion at the level of treatment. As an alternative to spinal fusion, the Prestige® Cervical Disc is a breakthrough treatment.

According to a study regarding the cervical spine which included 541 patients, the Prestige® Cervical Disc in comparison to spinal fusion, was far superior in neurological success. In addition, those patients who received the Prestige® Cervical Disc had fewer revision surgeries. The neurological success rate was 24 month.

Dr. Todd Lanman, Chief of Neurosurgery at Century City Doctors Hospital in Los Angeles, said that he believes the Prestige® Cervical Disc will greatly help his Hispanic patients since many Hispanic workers have neck problems as a result of their work and suffer from degenerative disc disease (DDD).

The Prestige® Cervical Disc is made of a stainless steel two-piece ball-and trough configuration which functions like a joint. It is available in a number of sizes for a variety of patients. The device offers the greatest potential for neck mobility.

Although Anterior Cervical Discectomy and Fusion (ACDF) is the most common surgical treatment for cervical DDD, the Prestige® Cervical Disc actually replaces a diseased disc and allows for flexibility and motion. Over 200,000 spinal fusion surgeries are performed yearly.