Healthcare Industry News: bone graft
News Release - January 23, 2006
INFUSE(R) Bone Graft/LT-CAGE(R) Lumbar Tapered Fusion Device Approved for Use in Australiabone graft Replacement for Spinal Fusion
MEMPHIS, Tenn.--(HSMN NewsFeed)--Jan. 23, 2006--Medtronic, Inc. (NYSE:MDT ) announced today that the Australian Therapeutic Goods Administration (TGA) has approved INFUSEŽ bone graft/LT-CAGEŽ, 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. 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 2 (rhBMP-2) and an absorbable collagen sponge (ACS). 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) specifically for use in lumbar spinal fusion procedures to treat degenerative disc disease. INFUSEŽ 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 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.
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.
INFUSEŽbone graft in combination with LT-CAGEŽ, INTER FIX(TM) or INTER FIX(TM) RP Implants and LT-CAGEŽ System incorporate technology developed by Gary K. Michelson, M.D.
The LT CAGEŽ Lumbar Tapered Fusion Device incorporates technology developed by Gary K. Michelson, M.D.
Issuer of this News Release is solely responsible for its
Please address inquiries directly to the issuing company.
Related News ItemsMedtronic Expands ENT Portfolio with FDA Clearance of NIM Vital(TM) Next Generation Intraoperative Nerve Monitoring System and Acquisiton of Ai Biomed Corp.
Medtronic Launches Head-to-Head TAVR Study Comparing the Evolut(TM) TAVR Platform Against the Edwards SAPIEN Valve in Small Annulus Patients
Medtronic Announces First Patient Implanted in ELITE Study of InterStim(TM) Micro