FDA approves INFUSE® bone graft which improves fracture healing

May 4 2004

Medtronic, Inc. has announced that the U.S. Food and Drug Administration (FDA) approved the use of INFUSE® Bone Graft in the treatment of acute, open fractures of the tibial shaft, a long bone in the lower leg. The approval broadens the indications for INFUSE Bone Graft, a product that has been used since 2002 in spinal surgery with metallic cages to treat tens of thousands of patients.

Approval of INFUSE Bone Graft was based on compelling data from a multi-center, prospective, randomized, clinical study of 450 patients. The study, published in the 2002 issue of the Journal of Bone and Joint Surgery, found that the addition of INFUSE Bone Graft improved healing in acute, open fractures of the tibial shaft when compared to standard treatment alone – a key benefit for both patients and physicians. INFUSE Bone Graft also reduced the need for secondary procedures by 44 percent.

“Because of the associated muscle damage and potential for infection, this type of fracture is difficult to heal,” said Mark Swiontkowski, M.D., orthopaedic surgeon and past president of the Orthopaedic Trauma Association. “INFUSE Bone Graft improves the chances of healing open tibial fractures without the surgeon having to reoperate.”

Open fractures of the tibia present a serious orthopaedic challenge because fracture healing often occurs slowly or not at all (nonunion). Nearly 62 percent of all nonunions occur in the tibia. Consequently, open tibia fractures frequently require additional operations to achieve bone healing, which often impedes a patient’s ability to return to work or normal activity. After severe open fractures, only 28 percent of patients return to their original work.

“INFUSE Bone Graft could rapidly become the standard of care in open tibia fractures,” said Alan Jones, M.D., associate professor and vice chairman in the department of orthopaedic surgery at the University of Texas Southwestern Medical Center at Dallas. “INFUSE Bone Graft enhances healing and seems to have a profound, independent effect on the need for secondary intervention after a fracture.”

Discovered and developed by Wyeth (NYSE: WYE), rhBMP-2 is manufactured in the company’s Andover, Mass., biopharmaceutical facility. In August 2003, Wyeth and Medtronic’s Spinal business reached an agreement on expanding Medtronic’s rights for rhBMP-2 for spine and orthopaedic indications. The Pre-Market Approval (PMA) application, which was based on the study published in the Journal of Bone and Joint Surgery, was originally submitted to the FDA by Wyeth and transferred to Medtronic immediately following FDA approval for this new indication.

INFUSE Bone Graft contains recombinant human bone morphogenetic protein (rhBMP-2), the genetically engineered version of a naturally occurring protein that is capable of inducing bone growth at the site of implantation. To use INFUSE Bone Graft, surgeons reconstitute rhBMP-2 powder with sterile water and apply it to a collagen sponge that is placed over the fracture site after appropriate wound management and fracture stabilization with an intramedullary nail, a metal rod placed inside the broken leg bone. For more information, visit  https://www.medtronic.com/in-en/index.html.