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. A pivotal, noninferiority, US FDA Investigational Device Exemption study demonstrated the. fractures, congenital pseudoarthrosis, and osseous defects from trauma, infection, and tumors ( 157 ). to treat various disorders, including delayed union and nonunion of. first recorded bone implant was performed in 1668. It remains the only dental bone graft substitute with FDA approved claims of superiority over demineralized bone matrix (DBM) allograft and alloplasts. Background: i-Factor Bone Graft (Cerapedics Inc, Westminster, Colorado) is a composite bone substitute material consisting of P-15 synthetic collagen fragment adsorbed onto anorganic bone mineral suspended in an inert biocompatible hydrogel carrier. Bone grafting is a very old surgical procedure. i-FACTOR Bone Graft is a bone graft substitute material for use in the repair of bony voids or. The product received PMA approval in 1999 based on the results of two prospective multi-center investigations. Only 2 FDA Class III PMA Approved Spinal Bone Grafts. 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. This novel (ABM/P-15) combination acts as an attachment factor for osteogenic cells. i-FACTOR bone graft received the CE Mark, a regulatory conformity marking for products on the European market, in late 2008. i-FACTOR™ Bone Graft is ready to use and thus requires no mixing or other preparation prior to use.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). Hydrogel Carrier- i-FACTOR Putty uses car-boxymethylcellulose (CMC), an inert and bio-compatible hydrogel, to aid in the handling and placement of the ABM/P-15 particles at the graft site. We are extremely pleased and excited about the FDA’s approval of i-FACTOR bone graft for cervical spinal fusions, a large and growing market segment that, up until now, has been lacking the optimal. 190, 192 This bone graft combination of ABM and P-15, also known as i-Factor, is claimed to facilitate bone formation. The proportion of i-FACTOR bone graft subjects with overall success was significantly higher than that of the autograft subjects (p 0.0382). I-FACTOR™ Bone Graft products are sterilized after packaging (terminally sterilized), can be stored at room temperature and have a three-year shelf life. ABM consists of smooth, porous particles of pure deproteinated hydroxyapatite. Joint reconstruction requiring a bone void filler.Treatment of non-union or traumatic fresh fractures.Spinal fusion incorporating interbody fusion devices i-FACTOR Peptide Enhanced Bone Graft is the only biologic bone graft in orthopedics that incorporates a small peptide as an attachment factor to stimulate the. I-Factor Bone Graft (Cerapedics, Inc., Westminster, CO) is a compound formed by peptide P-15 bound to an anorganic bone mineral of bovine origin that is composed of porous and smooth hydroxyapatite (ABM) particles.I-FACTOR™ Bone Graft products are intended to replace or augment the use of autologous bone commonly utilized in spine, trauma, and orthopedic procedures such as: This enables i-FACTOR™ Flex FR to provide significant new application options while retaining the safety and efficacy of P-15 technology. This novel mechanism of action increases the body’s natural bone healing process and thus leads to reliable. Fifty-two percent of patients in the I-FACTOR group had leaking of bone graft on X-ray at the six-week post-operative time point compared to 10 of the non-i-FACTOR group. This unique ABM/P-15 combination acts as a binding link for osteogenic cells.
Purified silk fibers, an inert carrier, provide enhanced: i-FACTOR is the only bone graft substitute on the market that binds a small, synthetically produced peptide (P-15) to an inorganic bone mineral (ABM). I-FACTOR™ Flex FR, with purified silk, retains the safety and biocompatibility of P-15 technology while providing superior out of packaging handling and in-vivo cohesive properties.
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