Medtronic Announces European Commission Approval of New Indication for InductOs for Spinal Surgery.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) 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 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. (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 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). 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 cord compression develops when the spinal cord is compressed by bone fragments from a vertebral fracture, a tumor, abscess, ruptured intervertebral disc or other lesion. . Spinal fusion, a surgery commonly used to treat degenerative disc disease, stabilizes the vertebrae Vertebrae Bones in the cervical, thoracic, and lumbar regions of the body that make up the vertebral column. Vertebrae have a central foramen (hole), and their superposition makes up the vertebral canal that encloses the spinal cord. 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 tibia: see leg. 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 tibial pertaining to the tibia. tibial crest a longitudinal prominence on the cranial border of the proximal tibia. Its proximal end (tibial tubercle) has a growth plate separate from the proximal tibia; hyperflexion injuries to 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 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
|
|
||||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion