Lumbar Tapered Fusion Device Approved For Use In Australia
Memphis, TN - Medtronic, Inc. announced that the Australian Therapeutic Goods Administration (TGA) has approved INFUSE Bone Graft/LT-CAGE, INTER FIX and INTER FIX RP 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. 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 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.
SOURCE: Medtronic, Inc.