Healthcare Industry News:  bone graft 

Devices Orthopaedic FDA

 News Release - March 13, 2007

Medtronic Receives Approval to Market INFUSE Bone Graft for Certain Oral Maxillofacial and Dental Regenerative Applications

MEMPHIS, Tenn.--(HSMN NewsFeed)--Medtronic, Inc. (NYSE:MDT ) today announced that it has received regulatory approval from the U.S. Food and Drug Administration (FDA) to begin marketing INFUSEŽ bone graft for certain oral maxillofacial and dental regenerative bone grafting procedures. This will be the third Pre-Market Approval (PMA) 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 bone grafts, or bone harvested from other parts of the patient such as the tibia (shin), ilium (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 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, an oral and maxillofacial surgeon with University Oral and Maxillofacial Surgery in Charlotte, North Carolina. "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 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 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.


Source: Medtronic

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