Infuse Bone Graft is approved for certain spine and orthopedic trauma surgeries. Next-generation, advanced synthetic bone grafts are being increasingly favored by surgeons because they play an active role in the bone healing process and can improve patient outcomes. The active ingredient in Infuse Bone Graft is rhBMP-2. Efficacy of i-Factor Bone Graft versus Autograft in Anterior. i-FACTOR Bone Graft vs Autograft in Anterior Cervical Discectomy and Fusion: 2-Year Follow-up of the Randomized Single-Blinded Food and Drug Administration Investigational Device Exemption Study. Infuse Bone Graft stimulates the growth of bone-forming cells, manufacturing new bone to replace or heal existing bone. scope of this Medical Coverage Policy include bone graft substitutes, bone void fillers. The product will receive limited market release for spine, trauma and orthopaedic applications in Europe and Asia Pacific. Arnold PM, Sasso RC, Janssen ME, Fehlings MG, Heary RF, Vaccaro AR, Kopjar B. Cerapedics (Westminster, Colorado) has CE marked its i-FACTOR Flex bone graft for sale in Europe. Results of the Prospective Randomized Single-blinded Food and Drug Administration Investigational Device Exemption Study. Efficacy of i-Factor™ Bone Graft versus Autograft in Anterior Cervical Disectomy and Fusion. It is used to fill bone cavities, defects, and fractures, and contains pores that. Arnold PM, Sasso RC, Janssen ME, Fehlings MG, Smucker JD, Vaccaro AR, Heary RF, Patel AL, Goulet B, Kalfas IH, Kopjar B. A sterile bioabsorbable device made primarily of animal-derived bone matrix (e.g., bovine) implanted into the body to provide osteoconductive bone-tissue scaffolds to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis). Enhanced cell attachment to anorganic bone mineral in the presence of a synthetic peptide related to collagen. synthetic bone grafts, Actifuse (Baxter, USA), i-FACTOR (Cerapedics. Biomimetic collagen scaffolds for human bone cell growth and differentiation. The gold standard bone graft for augmenting and achieving fusion is iliac crest. Enhanced cell attachment and osteoblastic activity by P-15 peptide-coated matrix in hydrogels. The effect of collagen 1 mimetic peptides on mesenchymal stem cells adhesion and differentiation, and on bone formation at hydroxyapatite surfaces.īiomaterials. Hennessy KM, Pollot BE, Clem WC, Phipps MC, Sawyer AA, Culpepper BK, Bellis SL. Cerapedics is now actively involved in introducing the i-FACTOR Bone Graft technology platform into the rapidly expanding market for osteobiologic products.1. Since approval, ABM/P-15 has been used in an estimated 500,000 procedures.įrom these roots, Cerapedics has reformulated the (ABM/P-15) product and branded it i-FACTOR Peptide Enhanced Bone Graft to capture the unique “attachment factor” mechanism of action. It remains the only dental bone graft substitute with FDA approved claims of superiority over demineralized bone matrix (DBM) allograft and alloplasts. The product received PMA approval in 1999 based on the results of two prospective multi-center investigations. The first P-15 enhanced bone graft substitute was developed for use in the oral cavity by CeraMed Dental – the precursor to Cerapedics – under the leadership of Andrew J. For i-Factor patients, the patient-reported outcome scores were: Neck Disability Index score: 28.3. GMDN Preferred Term Name GMDN Definition Bone matrix implant, animal-derived, bioabsorbable A sterile bioabsorbable device made primarily of animal-derived bone matrix (e.g., bovine) implanted into the body to provide osteoconductive bone-tissue scaffolds to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis). This novel (ABM/P-15) combination acts as an attachment factor for osteogenic cells. Fusion rate was 97.3 percent in the i-Factor group and 94.4 percent in the autograft group. i-FACTOR Bone Graft products are intended to replace or augment the use of autologous bone commonly utilized in spine, trauma, and orthopedic procedures.
Our lead technology platform (i-FACTOR Peptide Enhanced Bone Graft) is the only biologic bone graft that uses a unique small peptide attachment factor (P-15) bound to anorganic bone mineral (ABM).
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