Infuse Bone Graft
Bone Grafting (Oral Maxillofacial and Dental)
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Medtronic, Inc. (“Medtronic”) offers RemoteView, which permits a user (“Programmer User”) of the Medtronic CareLink® 2090 Programmer (“Programmer”) to allow the viewing of information presently displayed on the Programmer screen with one or more individuals in remote locations anywhere in the world (“Remote Viewer”), including remote health care professionals or Medtronic representatives.
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“Active Remote Viewer” as referred to herein shall mean a Remote Viewer that has installed the Licensed Software and has at the relevant point in time an active network connection to a Medtronic server via the Licensed Software.
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Bone Grafting (Oral Maxillofacial and Dental)
InfuseTM Bone Graft contains a manufactured bone graft material that is approved for use as a bone graft in 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.
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.
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.
Infuse Bone Graft stimulates the recruitment and differentiation of bone-forming cells inducing new bone formation or healing existing bone. It contains a recombinant version of bone morphogenetic protein-2 (rhBMP-2), which is known to be upregulated in the bone healing process assisting in bone regeneration.
Watch dental procedure videos and learn more about how Infuse Bone Graft works.
Bone morphogenetic proteins (BMP) play a role in the formation of bone and cartilage, the healing of fractures, and the repair of other musculoskeletal tissues.2
The preferred method for obtaining BMP is to manufacture a recombinant version of a naturally occurring BMP using well-established molecular biology technique (e.g., recombinant insulin). This production method results in pure solutions of a single BMP. Recombinant production offers the advantage of tightly controlled manufacturing processes to ensure purity, consistency and sterility.
The mechanism of action includes six steps. Table 1 includes an overview of the steps, and each step is described in detail below.
|TABLE 1: Mechanism of Action for rhBMP-2/ACS*|
|1. Implantation||rhBMP-2/ACS is implanted.|
|2. Chemotaxis||Migration of Mesenchymal Stem Cells and other bone-forming cells to the site of implantation|
|3. Proliferation||rhBMP-2/ACS provides an environment where stem cells multiply prior to differentiation.|
|4. Differentiation||rhBMP-2 binds to specific receptors on the stem cell surface signaling them to differentiate into osteoblasts.|
|5. Bone formation and Angiogenesis||Osteoblasts respond to local mechanical forces to produce new mineralized tissue replacing the ACS. New blood vessel formation is observed at the same time.|
|6. Remodeling||The body continues to remodel bone in response to the local environmental and mechanical forces, resulting in normal trabecular bone.|
Step 1: Implantation
When rhBMP-2 is placed on an absorbable collagen sponge (ACS) and implanted in the body, it produces new bone tissue at the site of implantation. Neither the rhBMP-2 nor the ACS can produce new bone tissue independently. Only when they're used together do they initiate the bone induction process.
Step 2: Chemotaxis
Bone-forming cells migrate to the area of the rhBMP-2/ACS implant. This cell migration stimulated by a chemical response is called chemotaxis. Mesenchymal stem cells (MSC) move from bleeding bone, muscle, and the periosteum to infiltrate the implant.
Step 3: Proliferation
The mesenchymal stem cells around the rhBMP-2/ACS implant increase in number. In-vitro studies have shown that rhBMP-2 can increase the proliferation of several multipotent cell lines, which can differentiate into osteoblasts, or bone-forming cells.3-7
Step 4: Differentiation
Binding to specific receptors on the surface of the MSC, rhBMP-2 causes them to differentiate into bone-forming cells.2, 7 In-vitro studies of rhBMP-2 support the fact that differentiation of mesenchymal stem cells into bone-forming osteoblasts plays an essential role in the induction of new bone.4,6 Pre-clinical studies have shown that rhBMP-2 can cause the differentiation of precursor cells into osteoblasts.3-19.
A 2003 in-vitro study compared the bone-forming activity of fourteen recombinant human bone morphogenetic proteins.20 Three cell lines, representing the different stages of osteoblast differentiation, were each tested. Alkaline phosphatase activity — a measure of the amount of new bone formation — was significantly increased in all three cell lines by BMP-2, BMP-6, and BMP-9. The researchers concluded that BMP-2, BMP-6, and BMP-9 may be the most potent agents to induce osteoblast lineage-specific differentiation of mesenchymal stem cells.
Step 5: Bone formation
As the sponge degrades or dissolves; these stem cells differentiate into osteoblast and begin to form trabecular bone and/or cartilage. Blood vessel formation (angiogenesis) is observed at the same time. The bone formation process develops from the outside of the rhBMP-2/ACS implant towards the center until the entire implant is replaced by trabecular bone.
Preclinical studies support that the bone formation started by rhBMP-2/ACS is self-limiting, forming a predictable amount of bone at the site of implantation. The ability of rhBMP-2 to induce new bone formation depends on its concentration. The rate of bone formation, the amount of bone formed, and the density of the resulting bone are positively correlated with both the concentration of rhBMP-2 and the length of time that rhBMP-2 is present at the implant site.1
Step 6: Remodeling
Remodeling of the trabecular bone induced by rhBMP-2 is consistent with the biomechanical forces placed on it. Radiographic, biomechanical, and histologic evaluation of the induced bone indicates that it functions biologically and biomechanically as native bone. Pre-clinical studies also indicate that the induced bone can repair itself, if fractured, in a manner indistinguishable from native bone healing.1
Find technical manuals in the Medtronic Manual Library, in the product labeling supplied with each product, or by calling Medtronic at 800-961-9055.
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
The commonly accepted mechanism of action as determined by in-vitro and in-vivo studies.
U.S. Food and Drug Administration. Summary of Safety and Effectiveness Data for Infuse Bone Graft/LT-Cage™ Lumbar Tapered Fusion Device (PMA Number P000058). Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf/p000058b.pdf. Accessed March 10, 2006.
Schmitt JM, Hwang K, Winn SR, Hollinger JO. Bone morphogenetic proteins: an update on basic biology and clinical relevance. J Orthop Res. 1999 Mar;17(2):269-278. Review.
Yamaguchi A, Katagiri T, Ikeda T, Wozney JM, Rosen V, Wang EA, Kahn AJ, Suda T, Yoshiki S. Recombinant human bone morphogenetic protein-2 stimulates osteoblastic maturation and inhibits myogenic differentiation in vitro. J Cell Biol. 1991 May;113(3):681-687.
Puleo DA. Dependence of mesenchymal cell responses on duration of exposure to bone morphogenetic protein-2 in vitro. J Cell Physiol. 1997 Oct;173(1):93-101.
Wilke A, Traub F, Kienapfel H, Griss P. Cell differentiation under the influence of rh-BMP-2. Biochem Biophys Res Commun. 2001 Jun 29;284(5):1093-1097.
Katagiri T, Yamaguchi A, Ikeda T, Yoshiki S, Wozney JM, Rosen V, Wang EA, Tanaka H, Omura S, Suda T. The non-osteogenic mouse pluripotent cell line, C3H10T1/2, is induced to differentiate into osteoblastic cells by recombinant human bone morphogenetic protein-2. Biochem Biophys Res Commun. 1990 Oct 15;172(1):295-299.
Bain G, Muller T, Wang X, Papkoff J. Activated beta-catenin induces osteoblast differentiation of C3H10T1/2 cells and participates in BMP2 mediated signal transduction. Biochem Biophys Res Commun. 2003 Jan 31;301(1):84-91.
Kawasaki K, Aihara M, Honmo J, Sakurai S, Fujimaki Y, Sakamoto K, Fujimaki E, Wozney JM, Yamaguchi A. Effects of recombinant human bone morphogenetic protein-2 on differentiation of cells isolated from human bone, muscle, and skin. Bone. 1998 Sep;23(3):223-231.
Gallea S, Lallemand F, Atfi A, Rawadi G, Ramez V, Spinella-Jaegle S, Kawai S, Faucheu C, Huet L, Baron R, Roman-Roman S. Activation of mitogen-activated protein kinase cascades is involved in regulation of bone morphogenetic protein-2-induced osteoblast differentiation in pluripotent C2C12 cells. Bone. 2001 May;28(5):491-498.
Hughes FJ, Collyer J, Stanfield M, Goodman SA. The effects of bone morphogenetic protein-2, -4, and -6 on differentiation of rat osteoblast cells in vitro. Endocrinology. 1995 Jun;136(6):2671-2677.
Boden SD, McCuaig K, Hair G, Racine M, Titus L, Wozney JM, Nanes MS. Differential effects and glucocorticoid potentiation of bone morphogenetic protein action during rat osteoblast differentiation in vitro. Endocrinology. 1996 Aug;137(8):3401-3407.
Thies RS, Bauduy M, Ashton BA, Kurtzberg L, Wozney JM, Rosen V. Recombinant human bone morphogenetic protein-2 induces osteoblastic differentiation in W-20-17 stromal cells. Endocrinology. 1992 Mar;130(3):1318-1324.
Yamaguchi A, Ishizuya T, Kintou N, Wada Y, Katagiri T, Wozney JM, Rosen V, Yoshiki S. Effects of BMP-2, BMP-4, and BMP-6 on osteoblastic differentiation of bone marrow-derived stromal cell lines, ST2 and MC3T3-G2/PA6. Biochem Biophys Res Commun. 1996 Mar 18;220(2):366-371.
Ikeuchi M, Dohi Y, Horiuchi K, Ohgushi H, Noshi T, Yoshikawa T, Yamamoto K, Sugimura M. Recombinant human bone morphogenetic protein-2 promotes osteogenesis within a telopeptide type I collagen solution by combination with rat cultured marrow cells. J Biomed Mater Res. 2002 Apr;60(1):61-69.
van den Dolder J, de Ruijter AJ, Spauwen PH, Jansen JA. Observations on the effect of BMP-2 on rat bone marrow cells cultured on titanium substrates of different roughness. Biomaterials. 2003 May;24(11):1853-1860.
Arpornmaeklong P, Kochel M, Depprich R, Kubler NR, Wurzler KK. Influence of platelet-rich plasma (PRP) on osteogenic differentiation of rat bone marrow stromal cells. An in vitro study. Int J Oral Maxillofac Surg. 2004 Jan;33(1):60-70.
Fromigue O, Marie PJ, Lomri A. Bone morphogenetic protein-2 and transforming growth factor-beta2 interact to modulate human bone marrow stromal cell proliferation and differentiation. J Cell Biochem. 1998 Mar 15;68(4):411-426.
Kim KJ, Itoh T, Kotake S. Effects of recombinant human bone morphogenetic protein-2 on human bone marrow cells cultured with various biomaterials. J Biomed Mater Res. 1997 Jun 5;35(3):279-285.
Lecanda F, Avioli LV, Cheng SL. Regulation of bone matrix protein expression and induction of differentiation of human osteoblasts and human bone marrow stromal cells by bone morphogenetic protein-2. J Cell Biochem. 1997 Dec 1;67(3):386-396.
Cheng H, Jiang W, Phillips FM, Haydon RC, Peng Y, Zhou L, Luu HH, An N, Breyer B, Vanichakarn P, Szatkowski JP, Park JY, He TC. Osteogenic activity of the fourteen types of human bone morphogenetic proteins (BMPs). J Bone Joint Surg Am. 2003 Aug;85-A(8):1544-52. Erratum in: J Bone Joint Surg Am. 2004 Jan;86-A(1):141.
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