INFUSE BONE GRAFT PRECLINICAL EVIDENCE Bone Grafting (Oral Maxillofacial and Dental)

INFUSE BONE GRAFT INDUCES MATURE, VIABLE BONE GROWTH

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.

PRECLINICAL DATA SHOWS SAFE AND EFFECTIVE BONE FORMATION1

Bone Grafting Oral Maxillofacial Infuse Preclinical Safety Pyramid Graphic

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


INFUSE BONE GRAFT INDUCES BONE SIMILAR TO AUTOGRAFT

Preclinical data indicated rhBMP-2/ACS induces bone with a normal histological appearance and cellular composition:

  • Induced bone similar to bone induced by autograft
  • Sinus floor augmentation with rhBMP-2/ACS induces histologic and histometric evidence of bone formation comparable to particulate cancellous bone and marrow in the rabbit model1
  • Excellent bone density was observed in core specimens removed from sites treated with rhBMP-2/ACS

INDUCED BONE ALLOWS OSSEOINTEGRATION AND FUNCTIONAL LOADING

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.

  • The bone-implant interface was compatible with that previously seen in ungrafted natural osseous ridges.
  • The maintenance of bone density and optimal remodeling patterns after functional loading indicate the potential value of implant-born function on BMP-reconstructed bone.

INDICATIONS, CONTRAINDICATIONS, WARNINGS, AND PRECAUTION FOR INFUSE BONE GRAFT FOR CERTAIN ORAL MAXILLOFACIAL AND DENTAL REGENERATIVE USES

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 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.

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.

An electronic version of the package insert may be found at www.medtronic.com/manuals.


1

PMA 050053. PMA 000058. PMA 000054. FDA Summary of Safety and Effectiveness Data