Protein Device Enhances Bone Healing

The device has been cleared by the U.S. Food and Drug Administration (FDA).

The device consists of rhBMP-2/ACS (recombinant human bone morphogenetic protein-2/absorbable collagen sponge) placed on an absorbable collagen sponge. It is used after stabilization with an intramedullary nail by orthopedic surgeons after proper wound management. The rhBMP-2, a recombinant version of a naturally occurring human protein, was discovered and developed by Genetics Institute, now part of Wyeth (Madison, NJ, USA), which is manufacturing the protein at a Wyeth biopharmaceutical facility in Andover (MA, USA).

The use of the device in more than 400 patients during surgery significantly improved the probability of fracture healing, as evidenced by a reduced need for secondary procedures to promote fracture healing when compared to the standard of care, fracture repair using an intramedullary nail. Medtronic Sofamor Danek (MSD, Memphis, TN, USA) will be marketing the product for tibia fractures, while purchasing the protein from Wyeth, which will receive royalties and milestone payments from MSD.

"This unique protein represents a breakthrough in orthopedic surgery as it can help improve fracture healing, while reducing the chances of infection,” said Joseph Camardo, M.D., senior vice president of Global Medical Affairs and medical director for Wyeth Pharmaceuticals North America. "It clearly represents a novel approach to orthopedic surgeons facing a serious tibia fracture.”




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Medtronic Sofamor Danek