i-FACTOR Bone Graft is ready to use and thus requires no mixing or other preparation prior to use. I-FACTOR Bone Graft products are sterilized after packaging (terminally sterilized), can be stored at room temperature and have a three-year shelf life. i-FACTOR Peptide Enhanced Bone Graft must be used inside an allograft bone ring and with supplemental anterior plate fixation. for use in the spine, and the only one for cervical spine. The investigators want to se whether i-FACTOR improves clinical outcomes compared to using allograft in spinal fusion in the elderly, and thereby find an improved methods operating this diffycult patient population. i-FACTOR Bone Graft is one of two FDA-approved drug-device combination products available in the U.S. i-FACTOR Bone Graft is a peptide bone matrix (PBM) a composite bone substitute consisting of a synthetic collagen fragment (P-15) bound to calcium phosphate. 10,11 According to these special controls, bone grafts intended to fill bony voids or gaps caused by trauma or surgery that are not intrinsic to the bony structure’s. It is an osteoconductive and osteoinductive biomaterial and is approved as a. premarket approval for biologic bone graft in the cervical spine. FDA has published two special controls guidance documents related to bone grafts, 8,9 which comply with the special controls proposed in 21 CRF §888.3045, and 21 CFR §872.3930. Request PDF i-Factor Bone Graft vs Autograft in Anterior Cervical Discectomy and Fusion: 2-Year Follow-up of the Randomized Single-Blinded Food and Drug. Demineralized bone matrix (DBM) is a form of allograft using acidic solution to remove mineral components, while leaving much of the proteinaceous components native to bone, with small amounts of calciumbased solids, inorganic phosphates, and some trace cell debris. I-FACTOR Peptide Enhanced Bone Graft is indicated for use in skeletally mature patients for reconstruction of a degenerated cervical disc at one level from C3-C4 to C6-C7 following single-level discectomy for intractable radiculopathy (arm pain and/or a neurological deficit), with or without neck pain, or myelopathy due to a single-level abnormality localized to the disc space, and corresponding to at least one of the following conditions confirmed by radiographic imaging (CT, MRI, X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height as compared to adjacent levels, after failure of at least 6 weeks of conservative treatment. In November 2015, i-FACTOR Putty became the first to receive U.S.
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