Infuse®Bone Morphogenic Protein

INFUSE® Bone Graft

Oral-maxillofacial surgery

INFUSE® Bone Graft contains a manufactured bone graft material that is approved by the U.S. Food and Drug Administration (FDA) for use in certain maxillofacial bone grafting procedures, such as sinus augmentation and localized alveolar ridge augmentation. It provides an alternative to bone-harvest surgery, a secondary procedure which can be painful for some patients and lengthens the healing process. INFUSE® Bone Graft provides proven, predictable bone formation and is supported by extensive research and clinical results.

Forming new bone with rhBMP-2

The active ingredient in INFUSE® Bone Graft is recombinant human bone morphogenetic protein-2 (rhBMP-2). rhBMP-2 is a manufactured version of a natural protein found in small quantities in the body. The purpose of the protein is to stimulate bone formation. Certain BMPs have been studied for decades because of their inherent ability to heal bone. Of these, rhBMP-2 has been studied more than any other BMP and is FDA-approved for use in certain oral surgeries.

Using INFUSE® Bone Graft in oral-maxillofacial surgeries

One of the primary advantages of INFUSE® Bone Graft is that it is an alternative to autograft—the use of autogenous bone (from the hip, rib, leg, jaw or chin) for implantation into a void or defect elsewhere in the body, such as the bones of the jaw.

During oral surgery with INFUSE® Bone Graft, the rhBMP-2 protein is mixed with sterile water. The solution is then soaked onto an absorbable collagen sponge (ACS), which is made from a material found in bone and tendons. The ACS releases the protein over time in the location where it is placed, providing a scaffold on which new bone can grow. As the graft site heals, the ACS is resorbed and replaced by bone.

In instances of jaw bone resorption, rhBMP-2 may be placed in the section or sections of the jaw bone that need to be built back up in preparation for dental implants.

Contraindications for INFUSE® Bone Graft surgery

• INFUSE® Bone Graft should not be used:

    – In patients with a known hypersensitivity to rhBMP-2, bovine Type I collagen or to any other components of the formulation
    – In the vicinity of a resected or extant tumor
    – In patients with any active malignancy or in patients undergoing treatment for a malignancy
    – In patients with an active infection at the operative site
    – In pregnant women

Additional Safety Information for INFUSE® Bone Graft

• Due to the chemotactic properties of INFUSE® Bone Graft and the angiogenesis associated with new bone formation, facial edema may occur in some (but not all) patients.
• INFUSE® Bone Graft has not been studied in investigational device exemption (IDE) trials with patients who:

    – Are skeletally immature (<18 years of age or no radiographic evidence of epiphyseal closure)
    – Currently are or may become pregnant