Please see the package insert for the complete list of indications, warnings, precautions, adverse events, clinical results, and other important medical information.Īn electronic version of the package insert may be found at /manuals. INFUSE ® Bone Graft has not been studied in consumers who are skeletally immature (<18 years of age or no radiographic evidence of epiphyseal closure). Women of childbearing potential should be advised to not become pregnant for one year following treatment with this device. The safety and effectiveness of this device has not been established in nursing mothers. Women of childbearing potential should be warned by their surgeon of potential risk to a fetus and informed of other possible dental treatments. In an experimental rabbit study, rhBMP-2 has been shown to elicit antibodies that are capable of crossing the placenta. There are no adequate and well-controlled studies in human pregnant women. INFUSE ® Bone Graft is contraindicated for consumers 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 consumers with any active malignancy or consumers undergoing treatment for a malignancy, in pregnant women, or consumers with an active infection at the operative site. In its June annual report, Medtronic noted that it had set aside more than 140 million for INFUSE litigation, and has paid 68 million in fiscal years 20. 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. These components must be used as a system for the prescribed indication. The INFUSE ® Bone Graft consists of two components–recombinant human Bone Morphogenetic Protein-2 (rhBMP-2) placed on an absorbable collagen sponge (ACS). 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. BRIEF SUMMARY OF INDICATIONS, CONTRAINDICATIONS, WARNINGS, AND PRECAUTION FOR INFUSE BONE GRAFT FOR CERTAIN ORAL MAXILLOFACIAL AND DENTAL REGENERATIVE USES
0 Comments
Leave a Reply. |