i-FACTOR™ Bone Graft Technology Platform
i-FACTOR Peptide Enhanced Bone Graft is the only biologic bone graft that utilizes a synthetic small peptide (P-15) bound to an anorganic bone mineral (ABM). This unique P-15/ABM combination acts as an attachment factor for osteogenic cells.
i-FACTOR Bone Graft technology is based on the biological activity of the synthetically derived 15-amino acid peptide found naturally in type I human collagen. Type I collagen is the primary organic component of bone. This 15-amino acid peptide (P-15) is responsible for the attachment, activation, and proliferation of osteogenic cells. These cells have an affinity for (attraction to) and attach to the P-15 found in i-FACTOR Bone Graft in a similar way they would naturally with type I collagen.
Unlike many synthetic growth factors, P-15 will only stimulate a healing response in the presence of bone forming cells. This anchorage-dependent healing response leads to safe, natural, and predictable bone formation.
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. i-FACTOR Peptide Enhanced Bone Graft must be used inside an allograft bone ring and with supplemental anterior plate fixation.
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 Bone Graft is ready to use and thus requires no mixing or other preparation prior to use.
i-FACTOR Bone Graft is currently available in the following form:
- Remove the syringe cap and dispense i-FACTOR Putty by depressing the syringe plunger.
- i-FACTOR Putty may be dispensed directly into the allograft ring or into a separate sterile receptacle where it can be transferred using traditional surgical instrumentation or by hand.
- The central cavity of the allograft should be filled with i-FACTOR Bone Graft.
IMPORTANT: Do not irrigate once implanted.