FDA Panel Unanimously Recommends Approval Of Medtronic, Inc.'s New PRESTIGE(R) Cervical Disc System
The panel's recommendation will be considered by the FDA in its review of the Premarket Approval (PMA) application for the device. With final approval of the PMA application, the PRESTIGE® Cervical Disc will be available to U.S. patients.
The FDA panel recommendation for approval is subject to additional conditions around labeling and post-approval testing.
The PRESTIGE® Cervical Disc System 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 (DDD) is cervical spine fusion. More than 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® Cervical Disc System underwent a prospective, multi-centered randomized clinical trial to assess the safety and effectiveness based on comparisons between data collected from skeletally mature patients with single level symptomatic cervical DDD at one level between C3-C7. The investigational group of 276 patients was implanted with the PRESTIGE® device while the control group of 265 patients received an anterior plated surgical fusion utilizing bone graft and plate stabilization.
Patients were evaluated preoperatively (within six months of surgery), intra-operatively, and postoperatively at six weeks, three, six, 12, and 24 months, and annually thereafter until the last subject enrolled in the study had been seen for their 24 month evaluation. Complications and adverse events were evaluated throughout the course of the clinical trial. At each evaluation time-point, the primary and secondary clinical and radiographic outcome parameters were evaluated. Success was determined from data collected during the initial 24 months of follow-up.
The PRESTIGE® Cervical Disc System is indicated in patients with cervical DDD. Cervical DDD is defined as intractable radiculopathy and/or myelopathy with symptomatic nerve root and/or spinal cord compression which is documented by patient history and radiographic studies.
"We are pleased with the panel's actions today because it brings this important technology one step closer to availability in the U.S.," said Ken Burkus, M.D. of the Hughston Clinic in Columbus, Ga. "We look forward to working with the FDA to obtain final approval."
About the Spinal Business at Medtronic
Medtronic's spinal business, based in Memphis, Tenn., 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 products and technologies for neurological, orthopedic and spinal 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 www.medtronicspinal.com and its patient-education Web sites, www.back.com, www.iscoliosis.com, www.maturespine.com and www.necksurgery.com.
About Medtronic
Medtronic, Inc. (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.
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 28, 2006. Actual results may differ materially from anticipated results.
Contact: Medtronic, Inc. Public Relations: Bert Kelly, 901-344-0614 or Investor Relations: Jeff Warren, 763-505-2696
Source: Medtronic, Inc.