Medtronic, Inc. has received US Food and Drug Administration (FDA) approval to market the Prestige Cervical Disc, the first artificial disc commercially available in the US for use in the neck.
The Prestige Cervical Disc gives some patients who are suffering from degenerative disc disease which can cause intolerable neck and/or arm pain, the potential for motion at the treated level, as well as another option for pain relief and function. Typically, a traditional motion-limiting spinal fusion procedure is indicated for these patients.
"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, Wis. "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 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.
In the largest study ever completed in the cervical spine involving 541 patients, results 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 Prestige Cervical Disc patients showed that they had a statistically superior overall neurological success rate at 24 months.
"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 Prestige Cervical Disc 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 DDD is an Anterior Cervical Discectomy and Fusion (ACDF). More than 200,000 cervical procedures are performed each year to relieve compression on the spinal cord or nerve roots and to implant an interbody graft and metal plate to rigidly fuse the vertebrae together.
The Prestige Cervical Disc underwent a prospective, multi-center, randomized clinical trial to assess its safety and effectiveness based on comparisons between data collected from patients with single-level symptomatic cervical DDD at one level between C3-C7. The investigational group of 276 patients received the Prestige Cervical Disc device while the 265 patients in the control group received an anterior plated surgical fusion utilizing bone graft and plate stabilization.
Medtronic's spinal and biologics business, based in Memphis, Tennessee., is the global leader in today's spine market and is committed to advancing the treatment of spinal conditions. Medtronic's spinal business collaborates with world-renowned surgeons, researchers and innovative partners to offer state-of-the-art therapies for spinal, neurological, orthopaedic and oral maxillofacial conditions.