Wyeth BMP-2 Should Be Limited To “Problem” Fractures – Panel
This article was originally published in The Gray Sheet
Executive Summary
Wyeth's InductOs recombinant human bone morphogenic protein-2 indications for use should be limited to "problem" fractures, according to FDA's Orthopaedic and Rehabilitation Devices Panel
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Long-awaited PMA approval granted for treating acute, open fractures of the tibial shaft with the product, which combines recombinant human bone morphogenetic protein (rhBMP-2) and an absorbable collagen sponge. Developed and manufactured by Wyeth and marketed by Medtronic Sofamor Danek, InFuse is inserted after a fracture has been stabilized with an intermedullary nail. Previously approved for use with a spinal fusion cage for degenerative disc disease (InFuse/LT-Cage) and intended to enhance bone healing, the product was recommended for broader approval by FDA's Orthopaedic & Rehabilitation Devices Panel in 2002 (1"The Gray Sheet" Nov. 25, 2002, p. 15). Since July 2003, the device has been marketed in Europe as InductOs...
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