FDA Panel Unanimously Recommends Approval of Third Indication for Medtronic's INFUSE Bone Graft.Technology Provides New Alternative to Painful Surgery to Harvest Bone 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 that the 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. Dental Products Advisory Panel has unanimously voted to recommend approval, with a condition the use of INFUSE[R] Bone Graft for certain oral and maxillofacial bone grafting procedures. This will be the third Premarket Approval Application (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 ) voted for panel approval since 2002 for INFUSE Bone Graft. The condition surrounds the wording of the product labeling. If the FDA agrees with the panel's recommendation, the indications in the U.S. for INFUSE Bone Graft will be expanded to include certain dental procedures. The oral surgery standard of care for procedures requiring bone augmentation is to harvest bone from other sites in the patient and implant it where needed. It is estimated that more than 350,000 bone grafting procedures of this type are performed in the U.S. each year. The recommendation for approval of INFUSE Bone Graft is an option for patients to avoid the pain and cost of harvesting bone graft. The PMA submission was primarily based on data from a program of prospective, 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. , controlled clinical trials involving 312 patients to assess the safety and effectiveness of INFUSE Bone Graft. Patients were evaluated for 36 months including evaluations at the time of bone grafting, dental implant and prosthesis prosthesis (prŏs`thĭsĭs): see artificial limb. prosthesis Artificial substitute for a missing part of the body, usually an arm or leg. placement, and longer term functional loading of dental implants. In the pivotal study, INFUSE Bone Graft exceeded its primary endpoint of functional dental implant loading (ability to chew). INFUSE Bone Graft is recombinant human bone morphogenetic morphogenetic /mor·pho·ge·net·ic/ (mor?fo-je-net´ik) producing growth; producing form or shape. protein-2 (rhBMP-2) applied to an absorbable collagen sponge carrier. The purpose of the protein, which occurs naturally in the body, is to stimulate bone formation. It has been previously approved by the FDA for use in certain lumbar spine fusion and 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 fracture repair procedures. Implanted into a bone-deficient site, INFUSE Bone Graft works with the body's own biology to induce normal physiologic bone formation. "We are pleased by the panel's endorsement of this product for this new indication. The clinical and scientific evidence supporting INFUSE Bone Graft has been validated in its proven success in spine and trauma applications, and we look forward to providing this product for oral surgery patients," said Pete Wehrly, senior vice president and president of the Spinal and Navigation business at Medtronic. Philip Boyne, D.M.D., M.S., D.S.c., Professor Emeritus, Department of Oral and Maxillofacial Surgery Oral and Maxillofacial Surgery is surgery to correct a wide spectrum of diseases, injuries and defects in the head, neck, face, jaws and the hard and soft tissues of the oral and maxillofacial region. It is a recognized international surgical specialty.
More information about approved uses of INFUSE Bone Graft can be found at www.infusebonegraft.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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