Yet, with dangerous results doctors have been using Infuse in unapproved neck (cervical) and lower back fusions. They were not given approval for use in neck surgeries or surgeries originating through the side or back. In 2002, Medtronic received limited approval from the Food and Drug Administration (FDA) to use their synthetic bone protein in specific surgeries on the lower spine that approach from the front only, tibia fractures, sinus augmentation and some dental procedures. This allows doctors to implant a synthetic bone graft instead of using bone from a cadaver or harvesting a graft from a patient’s hip, which can be painful. Infuse contains recombinant human Bone Morphogenetic Protein, which triggers bone growth. Nursing Home / Adult Living Facility Abuse and Neglect.Medical Negligence & Nursing Home Abuse.Women of childbearing age should be warned of potential risks to a fetus and should discuss other possible treatments with their doctor.įor more information about INFUSE Bone Graft please visit. Women of childbearing age should not become pregnant for one year following treatment with the product. This product has also not been studied in nursing mothers. This product has not been tested in pregnant women to determine if it could harm a developing fetus.INFUSE Bone Graft should not be used in the vicinity of a resected or extant tumor, in patients with any active malignancy or patients undergoing treatment for malignancy.INFUSE Bone Graft should not be used in patients with an active infection at the operative site.INFUSE Bone Graft has not been studied in patient who are skeletally immature (This is most likely due to the influx of the patient’s own cells and fluids into the treatment site. The potential for prolonged swelling may occur in some (but not all) patients.Important Information about INFUSE ® Bone Graft: Supported by over 20 years of research and clinical results, including 60 preclinical studies and 5 clinical trials.
Provides proven, predictable bone formation by combining the bone-generating power of rhBMP-2 with a proven carrier, the absorbable collagen sponge.Regenerates 100% vital, vascular de novo bone with no residual graft material remaining to destabilize bone formation.Eliminates the need for a second bone harvest surgery.Winner of the 2008 Prix Galien USA Award for best Biotechnology agent This led to the isolation of bone morphogenetic proteins (BMPs), the only proteins known to induce new bone formation (osteoinduction).Ģ002: INFUSE Bone Graft received approval for use in anterior lumbar spine fusion with Medtronic titanium threaded interbody devices.Ģ004: INFUSE Bone Graft received approval for use in open tibial fractures with intramedullary (IM) nail fixation.Ģ007: INFUSE Bone Graft received approval for use in sinus augmentation and for localized ridge augmentation for defects associated with extraction sockets. Urist discovers that demineralized bone matrix stimulates the formation of new bone tissue in lower-order animal muscle. The history of rhBMP-2 extends back decades, providing a wealth of research and studies to support its ability to induce new bone formation.ġ965: Dr.
Important information about INFUSE ® Bone Graft
Mesenchymal stem cells proliferate, or increase rapidly in number, at the site due to the presence of rhBMP-2, supported by increased angiogenesis at the site.Chemotaxis, or attraction of mesenchymal stem cells to the site, occurs.INFUSE Bone Graft is implanted in the surgical site.The rhBMP-2 mechanism of action initiates the body’s own bone-healing cascade: This particular protein has been proven to be an important element in the body’s own bone-healing cascade, inducing cells to form biologic bone via osteoinduction. The active component of INFUSE Bone Graft - rhBMP-2- is a recombinantly-produced form of a signaling protein naturally occurring in the human body. INFUSE Bone Graft promotes natural bone growth to give you long-term implant success.
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