Healthcare Industry News: cervical spine
News Release - May 23, 2007
Medtronic's Bryan(R) Cervical Disc System to Be Reviewed by FDA PanelMEMPHIS, Tenn.--(HSMN NewsFeed)--Medtronic, Inc. (NYSE:MDT ) recently announced the BryanŽ Cervical Disc System will be reviewed by the U.S. Food and Drug Administration's (FDA) Orthopedic and Rehabilitation Devices advisory panel on July 17, 2007.
William Hawkins, president and chief operating officer, made the announcement during Medtronic's fourth quarter earnings conference call on Tuesday, May 22. If the panel votes to recommend approval, the FDA will consider this vote when deciding on full approval. The Bryan Cervical Disc System is the second disc arthroplasty system for the cervical spine to be reviewed by an FDA panel. The first, Medtronic's PrestigeŽ Cervical Disc, is currently under evaluation by the FDA with expected approval later this summer.
The Bryan Cervical Disc is designed to alleviate pain and preserve motion and flexibility while replacing a diseased disc that is removed from a patient's cervical spine. Traditionally, 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 roots and to implant a metal plate to rigidly fuse the vertebrae together.
The Bryan Cervical Disc underwent a multi-center prospective, randomized, controlled, equivalency clinical trial to assess the safety and effectiveness based on comparisons between data collected from 463 skeletally mature patients with single level symptomatic cervical DDD at one level between C3-C7. The investigational group of 242 patients was implanted with the Bryan Cervical Disc, while the control group of 221 patients received a single level anterior interbody fusion procedure with allograft and plate stabilization.
In the clinical trial, cervical DDD was defined as a combination of the following: disc herniation with radiculopathy, spondylotic radiculopathy, disc herniation with myelopathy, or spondylotic myelopathy.
About the Spinal Business at Medtronic
The Spinal and Biologics business of Medtronic, based in Memphis, Tenn., is the global leader in today's spine market and 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, oral maxillofacial 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.
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.
The BryanŽ Cervical Disc System incorporates technology developed by Gary K. Michelson, M.D.
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