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Medtronic InFuse bone graft

This article was originally published in The Gray Sheet

Executive Summary

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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