
INFUSE® Bone Graft (trauma) - INFUSE® Bone Graft aids the treatment of acute, open fractures of the tibial shaft, a bone in the lower leg. INFUSE® Bone Graft is used in addition to wound management and fracture stabilization using an intermedullary nail, also known as an IM nail, a metal rod placed inside of your broken lower leg bone.
A study, published in a 2002 issue of the Journal of Bone and Joint Surgery, found that INFUSE® Bone Graft improved healing in acute, open tibia fractures when compared to standard wound care - a key benefit for both patients and physicians. INFUSE® Bone Graft also reduced the need for secondary procedures by 44 percent.
If you have any questions or need additional information about INFUSE® Bone Graft, you can visit www.infusebonegraft.com or talk to your doctor, who is the only one qualified to diagnose and treat your fracture. As with any surgical procedure, you should find a doctor who is experienced in performing the specific surgery that you are considering.
What is INFUSE® Bone Graft?
INFUSE® Bone Graft consists of two parts - a solution containing rhBMP-2 (recombinant human bone morphogenetic protein 2) and the ACS (absorbable collagen sponge). The protein is a genetically engineered version of a natural protein normally found in small quantities in the body. The purpose of the protein is to stimulate bone formation.
Watch a video about INFUSE® Bone Graft.
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The History of BMP
More than 40 years ago, orthopedic surgeons determined that the protein extracts required for bone to heal, or regenerate, in the body were contained within the bone itself. In 1979, Dr. Marshall Urist, a professor in the Department of Orthopaedic Surgery at the University of California at Los Angeles School of Medicine, coined the term "bone morphogenetic protein" (BMP) to describe these proteins.
Dr. Urist determined that bone contains only trace amounts of naturally occurring BMP, and that isolating enough BMP to be clinically useful would require hundreds of kilograms of donor (cadaveric) bone. Therefore, scientists concluded that producing a recombinant version of BMP was the only practical option for using BMP in routine medical procedures for endochondral bone formation.
To produce a practical version of BMP, scientists isolated one protein (BMP-2) from the bone tissue and used recombinant DNA technology to create genetically engineered cells, which they called recombinant human BMP-2 (rhBMP-2). Through this process, they determined that the cells they created could produce pure, natural human BMP-2 protein, a substance capable of initiating bone growth.
Approximately 20 BMPs with different amino acid structures have been isolated to date, but only six appear capable of initiating bone growth. Of these, BMP-2 has demonstrated the potential to form bone.
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
Caution: For use on or by the order of a physician only.
See the Package Insert for labeling warnings, precautions, and other important information.
Important Safety Information
It is important that you discuss the potential risks, complications, and benefits of the INFUSE® Bone Graft with your doctor prior to receiving treatment, and that you rely on your physician's judgment. Only your doctor can determine whether you are a suitable candidate for this treatment.
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