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:

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i-FACTOR Putty combines a unique anorganic bone mineral (ABM) and small peptide (P-15) that acts as an attachment factor for specific integrins on osteogenic cells. This novel mechanism of action enhances the body’s natural bone healing process resulting in safe, predictable bone formation. The Putty handling characteristics allow it to be used in an allograft ring.

 

Handling Instructions

  • 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.

 

Size and Ordering Information

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