FDA Panel Unanimously Recommends Approval of Medtronic's New PRESTIGE(R) Cervical Disc System.MEMPHIS Memphis, city, ancient Egypt Memphis (mĕm`fĭs), ancient city of Egypt, capital of the Old Kingdom (c.3100–c.2258 B.C.), at the apex of the Nile delta and 12 mi (18 km) from Cairo. , Tenn. -- Medtronic, Inc. (NYSE NYSE See: New York Stock Exchange :MDT) today announced the PRESTIGE(R) Cervical Disc System has received a unanimous recommendation for approval from the United State's Food and Drug Administration's (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) Orthopedic and Rehabilitation Devices advisory panel. The panel's recommendation will be considered by the FDA in its review of the Premarket Approval (PMA PMA (papillary-marginal-attached), n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation. PMA Progressive muscular atrophy ) application for the device. With final approval of the PMA application, the PRESTIGE(R) 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(R) 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 Degeneration of the intervertebral disc, which is often called "degenerative disc disease" (DDD) of the spine, is a common disorder of the lower spine and for some people can cause low back pain and/or leg pain (sciatica). (DDD) is cervical spine fusion cervical spine fusion Orthopedics The operative fusing of 2 or more cervical vertebrae due to trauma to the spine and/or bone degeneration . 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 Vertebrae Bones in the cervical, thoracic, and lumbar regions of the body that make up the vertebral column. Vertebrae have a central foramen (hole), and their superposition makes up the vertebral canal that encloses the spinal cord. together. The PRESTIGE(R) Cervical Disc System underwent a prospective, multi-centered randomized clinical trial randomized clinical trial, n a clinical study where volunteer participants with comparable characteristics are randomly assigned to different test groups to compare the efficacy of therapies. 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(R) 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 radiographic (rā´dēōgraf´ik), adj relating to the process of radiography, the finished product, or its use. outcome parameters were evaluated. Success was determined from data collected during the initial 24 months of follow-up. The PRESTIGE(R) Cervical Disc System is indicated in patients with cervical DDD. Cervical DDD is defined as intractable radiculopathy and/or myelopathy myelopathy /my·elop·a·thy/ (mi?e-lop´ah-the) 1. any functional disturbance and/or pathological change in the spinal cord; often used to denote nonspecific lesions, as opposed to myelitis. 2. with symptomatic nerve root and/or spinal cord compression Spinal cord compression develops when the spinal cord is compressed by bone fragments from a vertebral fracture, a tumor, abscess, ruptured intervertebral disc or other lesion. 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. |
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