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Preclinical studies demonstrated that Infuse™ Bone Graft produced mature, viable bone, indistinguishable from native bone. These studies also provided information on osseointegration of placed endosseous dental implants, and their long-term survival following functional loading.
Infuse Bone Graft has been extensively studied for both safety and bone-forming effectiveness in models of increasing difficulty from rat through human clinical studies.
The 60 preclinical studies — lower-order animals, followed by eight studies of non-human primates — observed the effects of recombinant human bone morphogenetic protein-2 (rhBMP-2), applied to an absorbable collagen sponge (ACS), in bone formation.
The preclinical studies determined that the higher order animals require higher concentration of rhBMP-2. Infuse Bone Graft is the only autograft alternative tested at the species-appropriate concentration for results that can be replicated.1
Preclinical data indicated rhBMP-2/ACS induces bone with a normal histological appearance and cellular composition:
The data also showed that rhBMP-2/ACS induced bone allows installation, osseointegration, and long-term functional loading of dental implants.
No significant difference exists in osseointegration between rhBMP-2/ACS augmented bone and the immediate adjacent resident bone.
INFUSE® Bone Graft is indicated as an alternative to autogenous bone graft for sinus augmentations, and for localized alveolar ridge augmentations for defects associated with extraction sockets.
The INFUSE® Bone Graft consists of two components–recombinant human Bone Morphogenetic Protein-2 (rhBMP-2) placed on an absorbable collagen sponge (ACS). These components must be used as a system for the prescribed indication. The bone morphogenetic protein solution component must not be used without the carrier/scaffold component or with a carrier/scaffold component different from the one described in the package insert.
INFUSE® Bone Graft is contraindicated for patients with a known hypersensitivity to recombinant human Bone Morphogenetic Protein-2, bovine Type I collagen or to other components of the formulation and should not be used in the vicinity of a resected or extant tumor, in patients with any active malignancy or patients undergoing treatment for a malignancy, in pregnant women, or patients with an active infection at the operative site.
There are no adequate and well-controlled studies in human pregnant women. In an experimental rabbit study, rhBMP-2 has been shown to elicit antibodies that are capable of crossing the placenta. Women of childbearing potential should be warned by their surgeon of potential risk to a fetus and informed of other possible dental treatments. The safety and effectiveness of this device has not been established in nursing mothers. Women of childbearing potential should be advised to not become pregnant for one year following treatment with this device.
INFUSE® Bone Graft has not been studied in consumers who are skeletally immature (<18 years of age or no radiographic evidence of epiphyseal closure).
Please see the package insert for the complete list of indications, warnings, precautions, adverse events, clinical results, and other important medical information.
PMA 050053. PMA 000058. PMA 000054. FDA Summary of Safety and Effectiveness Data