INFUSE(R) Bone Graft/LT-CAGE(R) Lumbar Tapered Fusion Device Approved for Use in Australia; Bone Graft Replacement for Spinal Fusion.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 MDT abbr. Mountain Daylight Time MDT (in the US and Canada) Mountain Daylight Time MDT n abbr (US) (= mountain daylight time) → ) announced today that the Australian Therapeutic Goods Administration The Therapeutic Goods Administration or TGA is the regulatory body for therapeutic goods (including medicines, medical devices, gene technology, and blood products) in Australia. (TGA) has approved INFUSE(R) Bone Graft/LT-CAGE(R), INTER FIX(TM) and INTER FIX RP(TM) devices for spinal fusion. This approval means INFUSE Bone Graft will be available nationwide in Australia. The INFUSE Bone Graft/LT-CAGE Device was designed to aid in the treatment of degenerative disc disease Degeneration of the intervertebral disc, which is often called "degenerative disc disease" (DDD) of the spine, is a common disorder of the lower spine and for some people can cause low back pain and/or leg pain (sciatica). . It consists of two parts - a small, hollow, threaded, tapered metal cylinder and a bone graft substitute. The LT-CAGE Lumbar Tapered Fusion Device is intended to restore the degenerated disc space to its original height, relieving pressure on the nerves. Two of the cages are placed side-by-side during surgery. The cages are filled with INFUSE Bone Graft, which consists of recombinant human Bone Morphogenetic Protein Bone Morphogenetic Proteins (BMPs) are a group of growth factors and cytokines known for their ability to induce the formation of bone and cartilage. Types Originally, seven such proteins were discovered. 2 (rhBMP-2) and an absorbable collagen sponge (ACS (Asynchronous Communications Server) See network access server. ). The protein is a genetically engineered version of a natural protein normally found in small quantities in the body. The protein stimulates bone formation. During surgery the protein solution is soaked into the ACS. The ACS acts as a scaffold for the formation of new bone. Over time the ACS resorbs, or disappears, in the body. "INFUSE Bone Graft/LT-CAGE allows Australian spinal surgery patients access to a treatment that eliminates painful bone graft harvesting whilst at the same time creating a fusion," said Dr. Peter McCombe of St Andrew's War Memorial Hospital, Brisbane, Australia. INFUSE Bone Graft is the only bone graft replacement to receive a U.S. 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 ) specifically for use in lumbar spinal fusion procedures to treat degenerative disc disease. INFUSE(R) Bone Graft also can make spinal fusion easier on patients by eliminating the traditional bone harvesting from a patient's hip. Degenerative disc disease occurs when discs in the spine are deteriorating or damaged, and can be extremely painful and debilitating de·bil·i·tat·ing adj. Causing a loss of strength or energy. Debilitating Weakening, or reducing the strength of. Mentioned in: Stress Reduction 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. Approximately 250,000 people last year required spinal fusion surgery to relieve their low back pain. Patients seeking information on INFUSE Bone Graft/LT-CAGE can visit www.back.com. About Medtronic Sofamor Danek Medtronic Sofamor Danek, based in Memphis, Tenn., is the global leader in today's spine market and is committed to advancing the treatment of spinal disorders. Medtronic's Spinal business collaborates with world-renowned surgeons, researchers and innovative partners to offer state-of-the-art products and technologies for neurological 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.medtronicsofamordanek.com and its consumer 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 Quarterly Report on Form 10-Q for the quarter ended October 28, 2005. 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 Implants and LT-CAGE(R) System incorporate technology developed by Gary K. Michelson Gary K. Michelson, founder of Karlin Technology, is a surgeon turned inventor. On April 22, 2005, Medtronic Inc. paid US$ 1.35 billion to settle a patent lawsuit and also to acquire his spine surgery-related patents. External links
The LT CAGE(R) Lumbar Tapered Fusion Device incorporates technology developed by Gary K. Michelson, M.D. |
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