Healthcare Industry News:  bone graft 

Devices Orthopaedic FDA

 News Release - November 9, 2006

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, Tenn.--(HSMN NewsFeed)--Medtronic, Inc. (NYSE:MDT ) today announced that the FDA Dental Products Advisory Panel has unanimously voted to recommend approval, with a condition the use of INFUSEŽ bone graft for certain oral and maxillofacial bone grafting procedures. This will be the third Premarket Approval Application (PMA) 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, 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 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 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 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 at Loma Linda University & Medical Center has done extensive research in this area since 1991. Boyne adds, "It is a tribute to the approval process that sustained efforts by so many basic scientists and clinicians can be recognized and utilized so that this valuable product may be made available to improve the health status of so many patients."

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.


Source: Medtronic

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