Medtronic Submits Application to FDA for Posterior Spinal Indication for rhBMP-2; New Formulation and Carrier, Called AMPLIFY(TM) rhBMP-2 Matrix, Could Broaden the Protein's Indications for the Third Time in Three Years.PHILADELPHIA -- Medtronic, Inc. (NYSE NYSE See: New York Stock Exchange :MDT) today announced the submission of a pre-market 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 to the U.S. Food and Drug Administration (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. ) for the use of rhBMP-2 for posterior (back) lumbar spinal fusion surgeries. The new formulation and carrier, called the AMPLIFY(TM) rhBMP-2 Matrix, have been designed to meet the needs of these challenging spinal fusion cases. The PMA submission was based on data from a randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , prospective, clinical study involving more than 460 patients. The announcement came today during the North American Spine Society (NASS Nass (năs), river, 236 mi (380 km) long, rising in the Coast Mts., W British Columbia, Canada, and flowing SW to Portland Inlet of the Pacific Ocean. It is navigable for 25 mi (40 km) and has valuable salmon fisheries. ) meeting in Philadelphia. More than 250,000 lumbar spinal fusions are performed each year to stabilize 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. and help eliminate the pain caused by 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). in the spine. "We have a real commitment to evidence-based medicine, and rhBMP-2 has more level 1 clinical data than any other bone grafting technology," said Pete Wehrly, president and vice president of Medtronic's Spinal and Navigation businesses. "A new spinal indication could allow more patients to benefit from this revolutionary bone-healing technology." rhBMP-2 is a bone morphogenetic protein Bone Morphogenetic Proteins (BMPs) are a group of growth factors and cytokines known for their ability to induce the formation of bone and cartilage. Types Originally, seven such proteins were discovered. that stimulates new bone growth, or bone regeneration. Since its initial release in July 2002 as the active component in INFUSE(R) Bone Graft, rhBMP-2 has been used to treat more than 150,000 patients. Originally approved for anterior lumbar interbody fusion (ALIF) procedures, the indications for INFUSE Bone Graft were expanded in May 2004 to include the treatment of certain tibial tibial pertaining to the tibia. tibial crest a longitudinal prominence on the cranial border of the proximal tibia. Its proximal end (tibial tubercle) has a growth plate separate from the proximal tibia; hyperflexion injuries to fractures. INFUSE Bone Graft is currently the only bone graft replacement to receive PMA approval by FDA specifically proving efficacy for treating degenerative disc disease in the lumbar spine. The product currently has regulatory approval in more than 37 countries. About Medtronic Sofamor Danek Medtronic Sofamor Danek, 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 disorders. Medtronic's Spinal business collaborates with world-renowned surgeons, researchers and innovative partners to offer state-of-the-art products and technologies for neurological 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.medtronicsofamordanek.com and its consumer 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 29, 2005. Actual results may differ materially from anticipated results. |
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