Medtronic Receives Approval to Market INFUSE Bone Graft for Certain Oral Maxillofacial and Dental Regenerative Applications.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 it has received regulatory approval from 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. ) to begin marketing INFUSE[R] Bone Graft for certain oral maxillofacial and dental regenerative bone grafting procedures. This will be the third 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 receiving FDA approval since 2002 for the INFUSE Bone Graft technology. It is estimated that more than 350,000 bone grafting procedures to generate or regenerate bone in sinus augmentations and localized alveolar ridge augmentations for defects associated with extraction sockets are performed in the United States each year. Autogenous autogenous /au·tog·e·nous/ (aw-toj´e-nus) autologous. au·tog·e·nous or au·to·gen·ic adj. 1. Of or relating to autogenesis; self-generating. 2. bone grafts, or bone harvested from other parts of the patient such as the tibia (shin), ilium Ilium: see Troy. (hip) or chin, are currently the standard grafting procedure used for these patients. INFUSE Bone Graft offers surgeons and their patients an alternative to autogenous bone grafting, possibly reducing patients' pain, limiting scarring and reducing surgical time. INFUSE Bone Graft is also an alternative for bone grafting procedures that do not commonly use autogenous bone grafts such as for alveolar ridge augmentation associated with extraction site procedures. 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 fracture repair procedures. Implanted into a bone-deficient site, INFUSE Bone Graft works with the body's own biology to induce normal bone formation. "Patients come to see us with a multitude of problems and it's our job to help patients discover methods to achieve their goals," said Daniel Spagnoli, Ph.D., DDS (1) (Digital Data Storage) See DAT. (2) (Data Dictionary System) See QuickBuild and OpenDDS. (3) (Dataphone Digital S , an oral and maxillofacial surgeon Oral and maxillofacial surgeon A dentist who is trained to perform surgery to correct injuries, defects, or conditions of the mouth, teeth, jaws, and face. Mentioned in: Jaw Wiring with University 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.
Charlotte is the largest city in the state of North Carolina and the 20th largest city in the United States. . "When we talk to an individual, we have to think about more than the structural problem. We also consider the psychological and social aspects of missing teeth. INFUSE Bone Graft encourages bone growth to make it possible for them to have the corrective dental work that gives my patients a chance to have confidence, to feel good about their smile, to function well and to be able to enjoy a meal," he added. FDA approval for the selected use of INFUSE Bone Graft for certain oral maxillofacial and dental regeneration applications was based on five clinical studies involving 312 patients. This is the largest amount of clinical trial data for any similar product to date. In 2005, two of the studies supporting INFUSE Bone Graft approval were published in the journals of the professional associations of Oral and Maxillofacial Surgeons and Periodontists. Each study won the highest peer-granted awards of the respective professional groups, the Daniel M. Laskin Award and the E. Bud Tarrson Research Award, for the best clinical research paper of the year. "I know of no other studies on any oral maxillofacial applications that had such rigorous testing. INFUSE Bone Graft (rhBMP-2/ACS) has the most comprehensive, multi-centered, 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. Level I clinical data of any bone growing protein currently available," said Gilbert Triplett, Ph.D., DDS, chairman of the Dentistry Department at Baylor University Medical Center Baylor University Medical Center (BUMC) is located at 3500 Gaston Avenue in east Dallas, Texas (USA). Its medical services are often listed in the annual U.S. News & World Report compilation of Best Hospitals. in Dallas. Medtronic expects to have product available for surgeons trained in the indicated procedures by March 26. Patients and surgeons can learn more about the uses of INFUSE Bone Graft at www.infusebonegraft.com. About the Spinal Business at Medtronic The Spinal and Biologics business based in Memphis, Tenn., is the global leader in today's spine market and is committed to advancing the treatment of spinal conditions. The 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. 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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