INFUSE® Bone Graft
Information for Hospital Administrators
INFUSE® Bone Graft is recombinant human bone morphogenetic protein-2 applied to an absorbable collagen sponge carrier. One of the functions of the protein is to stimulate natural bone formation. Overall, bone morphogenetic protein technology has a lengthy history of extensive research and study dating back more than 50 years.
INFUSE® Bone Graft was cleared by the U.S. Food & Drug Administration in 2002 for use in Anterior Lumbar Interbody Fusion spine surgical procedures. Additional approvals were received in 2004 and 2007 for trauma and oral-maxillofacial (OMF) indications, respectively.
In 2008, INFUSE® Bone Graft received the coveted Prix Galien Award. The distinguished award recognizes those scientific technologies that have revolutionized their field and significantly impacted the practice of science and medicine. In 2015, Infuse Bone Graft/Medtronic Interbody Fusion Device was approved for:
The Infuse Bone Graft/Medtronic Interbody Fusion Device is indicated for spinal fusion procedures in skeletally mature patients for the treatment of degenerative disc disease (DDD) at one level from L2-S1 (the lower part of the back). DDD is defined as a disc that has deteriorated and causes back pain. The disc degeneration is confirmed by history and x-ray studies. Prior to this surgery, patients should have been non-responsive to at least six months on non-operative therapy.