Spine submission from Medtronic
This article was originally published in The Gray Sheet
Executive Summary
PMA submission for rhBMP-2 bone growth stimulator in posterior lumbar spinal fusion is announced Sept. 29 at the North American Spine Society meeting in Philadelphia. The recombinant bone morphogenetic protein - to be delivered via the Amplify matrix - is the active component in Medtronic's InFuse bone graft for tibia fractures, which entered the U.S. market in May 2004 (1"The Gray Sheet" May 17, 2004, p. 3). The PMA is supported by a randomized, prospective clinical study that enrolled more than 460 participants, Medtronic says...