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Medtronic, Inc. (NYSE:MDT), has received U.S. Food and Drug Administration (FDA) approval for the expanded use of INFUSE(R) Bone Graft with certain sizes of the INTER FIX(TM) and INTER FIX(TM) RP Threaded Fusion Devices.
INFUSE Bone Graft was approved in July 2002 by the FDA for use with the LT-CAGE(R) Lumbar Tapered Fusion Device. The use of INFUSE Bone Graft with INTER FIX and INTER FIX RP Threaded Fusion Devices required an FDA Premarket Approval (PMA) supplement and expands the use of this novel growth factor in treating back pain.
Using INFUSE Bone Graft with the INTER FIX and INTER FIX RP Threaded Fusion Devices reduces the pain and complications associated with treating degenerative disc disease by eliminating the second surgery required to harvest bone from a patient's hip for implantation in the spine, as is done in traditional spinal fusion procedures.
INFUSE Bone Graft contains recombinant human bone morphogenetic protein...