FDA Approval: Recombinant human bone morphogenetic protein-2 (rhBMP-2)

Medtronic recently announced that the FDA Dental Products Advisory Panel has unanimously voted to recommend approval, with a condition the use of INFUSE® Bone Graft for certain oral and maxillofacial bone grafting procedures. INFUSE Bone Graft is recombinant human bone morphogenetic protein-2 (rhBMP-2) applied to an absorbable collagen sponge carrier. The purpose of the protein, which occurs naturally in the body, is to stimulate bone formation. It has been previously approved by the FDA for use in certain lumbar spine fusion and tibial fracture repair procedures. Implanted into a bone-deficient site, INFUSE Bone Graft works with the body’s own biology to induce normal physiologic bone formation.

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