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FDA APPROVES EXPANDED USE OF MEDTRONIC'S INFUSE BONE GRAFT.

Medtronic, Inc. (NYSE:MDT), has received U.S. Food and Drug Administration (FDA) approval for the expanded use of INFUSE(R) Bone Graft with certain sizes of the INTER FIX(TM) and INTER FIX(TM) RP Threaded Fusion Devices.

INFUSE Bone Graft was approved in July 2002 by the FDA for use with the LT-CAGE(R) Lumbar Tapered Fusion Device. The use of INFUSE Bone Graft with INTER FIX and INTER FIX RP Threaded Fusion Devices required an FDA Premarket Approval (PMA) supplement and expands the use of this novel growth factor in treating back pain.

Using INFUSE Bone Graft with the INTER FIX and INTER FIX RP Threaded Fusion Devices reduces the pain and complications associated with treating degenerative disc disease by eliminating the second surgery required to harvest bone from a patient's hip for implantation in the spine, as is done in traditional spinal fusion procedures.

INFUSE Bone Graft contains recombinant human bone morphogenetic protein (rhBMP-2), the genetically engineered version of a naturally occurring protein that is capable of initiating bone growth, or bone regeneration, in specific, targeted areas in the spine. It is the only bone graft replacement currently approved by the FDA specifically for treating degenerative disc disease in the lumbar spine. The elimination of the hip graft harvesting procedure enables surgeons to avoid causing pain in one part of the body to cure it in another.

"Studies utilizing INFUSE Bone Graft as well as continued use in my practice show significant patient benefits," said Kenneth Burkus, M.D., an orthopedic surgeon at the Hughston Clinic in Columbus, Ga., and key clinical investigator for INFUSE Bone Graft. "This revolutionary technology is well on its way to becoming the new gold standard as an autograft replacement."

Degenerative disc disease occurs when discs in the spine are deteriorating or damaged, and can be extremely painful and debilitating in patients who generally lead active lives. Pain emanates from the damaged discs themselves or is caused by the discs or bone impinging on nearby nerve roots or the spinal cord. By the age of 50, approximately 85 percent of the population will show some evidence of disc degeneration. Spinal fusion, a commonly used surgical method of treating degenerative disc disease after conservative treatments have failed, essentially "welds" two vertebrae together to eliminate the pain caused by a damaged disc in the spine.

To use INFUSE Bone Graft, surgeons reconstitute the rhBMP-2 powder with sterile water and then apply it to collagen sponges. The sponges are inserted inside INTER FIX and/or INTER FIX RP Threaded Fusion Devices, a pair of which is then implanted between the vertebrae. The thimble-like cages stabilize the spine while it is fusing and also maintain the proper height between the vertebrae.

"It's exciting to see the FDA expand the use of INFUSE Bone Graft with other devices," said Michael DeMane, president of Medtronic's Spinal business. "This, along with the recent add-on payment approved by the Center for Medicare and Medicaid Services (CMS), specifically for patients who undergo spinal fusion surgery using INFUSE Bone Graft and cages, is a significant step forward in expanding patient access to this important therapy option."

Medtronic, Inc., headquartered in Minneapolis, is the world's leading medical technology company, providing lifelong solutions for people with chronic disease. Medtronic Sofamor Danek, the company's Spinal business, is the global leader in spinal technology. Headquartered in Memphis, Medtronic's Spinal business develops and manufactures products that treat a variety of disorders of the cranium and spine, including traumatically induced conditions, degenerative conditions, deformities and tumors.

The INTER FIX and INTER FIX RP Threaded Fusion Devices incorporate technology developed by Gary K. Michelson, M.D.

For more information, call 763/505-2635 or visit http://www.back.com and http://www.medtronicsofamordanek.com.
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Publication:Biotech Equipment Update
Geographic Code:1USA
Date:Feb 1, 2004
Words:625
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