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Medtronic Announces European Commission Approval of New Indication for InductOs for Spinal Surgery
Business Wire, April 19, 2005
MEMPHIS, Tenn. -- Medtronic Inc. (NYSE:MDT) today announced that the European Commission has approved a spinal fusion indication for InductOs(TM), the surgically implanted product containing recombinant human bone morphogenetic protein (rhBMP-2) that promotes new bone growth, or bone regeneration. With the new indication, InductOs is now available for use with the LT-CAGE(R) Device for single-level anterior (from the front) lumbar spinal fusion in adults with degenerative disc disease who have had at least six months of non-operative treatment for this condition.
With InductOs, patients can avoid the pain and complications associated with treating one aspect of degenerative disc disease by eliminating the surgery needed to harvest bone from the patient's hip, as has been traditionally done in spine fusion procedures. RhBMP-2 is a naturally occurring protein that results in the formation of new bone when implanted in specific, targeted areas in the spine by causing cells to differentiate into bone-forming cells.
Degenerative disc disease affects approximately half of the population age 40 and older and can cause a variety of symptoms, including back pain, nerve root pathology and spinal cord compression. Spinal fusion, a surgery commonly used to treat degenerative disc disease, stabilizes the vertebrae to eliminate the pain caused by a degenerated spinal disc.
InductOs was originally approved in September 2002 by the European Commission for use in the treatment of acute tibia fractures in adults, as an adjunct to standard care using open fracture reduction and intramedullary nail fixation. InductOs is used to increase the probability that tibial fractures will heal faster and reduce the need for additional surgeries to achieve complete healing.
RhBMP-2 has already been used safely and effectively in treating tens of thousands of patients suffering from lumbar degenerative disc disease in the United States where the product is known as INFUSE(R) Bone Graft. RhBMP-2 was introduced by Wyeth, and co-developed by Wyeth and Yamanouchi Pharmaceutical Co., Ltd. The protein is manufactured at a Wyeth biopharmaceutical facility in Andover, Mass.
Medtronic Sofamor Danek
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 today's spine market and is committed to advancing the treatment of spinal disorders. Headquartered in Memphis, Tenn., Medtronic's Spinal business has collaborated with world-renowned surgeons and researchers to develop products and technologies that offer a range of solutions for neurological and spinal conditions. More information about the company and its spinal treatments can be found at www.medtronicsofamordanek.com and its consumer sites, www.back.com, www.iscoliosis.com, www.maturespine.com and www.neckreference.com.
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 30, 2004. Actual results may differ materially from anticipated results.
INFUSE(R) Bone Graft in combination with LT-CAGE(R), INTER FIX(TM) or INTER FIX(TM) RP devices incorporate technology developed by Gary K. Michelson, M.D.
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