Memphis, TN–(HISPANIC PR WIRE – BUSINESS WIRE)–August 27, 2007–Medtronic, Inc. (NYSE:MDT) announced that it has received U.S. Food and Drug Administration (FDA) approval to market the Prestige(R) Cervical Disc, the first artificial disc commercially available in the U.S. 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 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.
“The patented ball-and-trough of the Prestige Cervical Disc is designed to permit motion at the treated level,” said Sergio Gonzalez-Arias, M.D., Chief of Neurosurgery and Director of Neurosciences at Baptist Hospital in Miami. “Now patients suffering from cervical degenerative disc disease (DDD) have an alternative to motion limiting spinal fusion.”
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.
“This approval will have an impact on my Hispanic patients,” said Todd Lanman, M.D., Chief of Neurosurgery at Century City Doctors Hospital in Los Angeles. “Many Hispanic workers that come to me are in labor intensive positions and neck problems can jeopardize their jobs. The Prestige Cervical Disc is a great treatment option for those patients who come into my office suffering from degenerative disc disease.”
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.
More information about the Prestige Cervical Disc can be found at http://www.necksurgery.com or http://www.prestigedisc.com.
About the Spinal and Biologics Business at Medtronic
The Spinal and Biologics business at Medtronic, based in Memphis, Tenn., is the global leader in today’s spine market and is committed to advancing the treatment of spinal conditions. The 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. Medtronic is committed to developing affordable, minimally invasive procedures that provide lifestyle friendly surgical therapies. More information about the company and its spinal treatments can be found at http://www.medtronicspinal.com and its patient-education Web sites, http://www.back.com, http://www.iscoliosis.com, http://www.maturespine.com and http://www.necksurgery.com.
Medtronic, Inc. (http://www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.
*Individual patient results may vary.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s Annual Report on Form 10-K for the year ended April 27, 2007. Actual results may differ materially from anticipated results.