July 24, 2007 – Medtronic’s FDA-cleared Prestige Cervical Disc is the first artificial disc commercially available in the U.S. for use in the neck. The Prestige Cervical Disc may offer patients who suffer from degenerative disc disease the potential to preserve motion at the treated level, as well as offer pain relief and function, the company says.
"The patented ball-and-trough of the Prestige Cervical Disc is designed to permit motion at the treated level," said J. Kenneth Burkus, M.D., an orthopedic surgeon at the Hughston Clinic in Columbus, Ga. "Now patients suffering from cervical degenerative disc disease (DDD) have an alternative to motion limiting spinal fusion."
The company reports that study results involving 541 patients showed that the Prestige Cervical Disc had superior outcomes in neurological success, as well as overall success, a measurement that includes several safety and effectiveness outcomes, when compared to spinal fusion. The study also showed equivalent Neck Disability Index measures and fewer revision surgeries for patients who received the Prestige Cervical Disc. Post-operative examination of the disc patients showed that they had a statistically superior overall neurological success rate at 24 months.
"As an active mom and an amateur triathlete, the Prestige Disc gave me back my life," said Stacey Brickson, a patient enrolled in the clinical study from Madison, WI. "I had so much pain and disability from an auto accident that I could not even lift my head off a pillow before I got the Prestige Disc, and I was too active to even think about a spinal fusion," she added.
As part of the FDA-approval conditions, Medtronic has agreed to conduct a seven-year post approval study to evaluate long-term safety and effectiveness. Medtronic is also going to perform a five-year enhanced surveillance study.