The 2018 Excellence in Surgical Products Awards will be presented in the November/December issue of Surgical Products. Leading up to the publication of that issue, nominees will be featured on the Surgical Products website.
Product description and innovation synopsis:
i-FACTOR Peptide Enhanced Bone Graft is based on proprietary biomimetic small peptide (P-15) technology that has a novel mechanism of action (attract, attach, and activate) that induces osteoblast cell proliferation and differentiation to accelerate new bone formation in patients with degenerative disc disease. The technology consists of a 15-amino acid sequence (cell-binding domain of human type I collagen placed on an anorganic bone mineral [ABM] carrier). This unique drug-device combination creates a surface-bound mechanism of action that enhances the body’s natural bone healing process.
What sets this product apart from others available in the industry?
Historically, the gold standard was using a bone graft obtained from the patient’s pelvis to promote fusion (autograft). This approach presents risks such as infection, nerve damage, bleeding, and chronic pain around the graft site. Other alternatives include bone morphogenetic proteins (BMPs), demineralized bone matrix (DBM), and stem cell therapies. While these products are commonly used by surgeons, the P-15 technology is supported by Level 1 human clinical data and has the potential to offer a safe, effective and economical alternative that surgeons need and that aligns with the values of healthcare systems.
How does this product benefit the surgical team and aid in better outcomes?
Completed clinical research indicates that i-FACTOR is statistically superior to autograft in overall patient success. For example, study results published in the peer-reviewed journal Spine involving 319 patients who underwent anterior cervical discectomy and fusion surgery showed that i-FACTOR was superior to autograft in composite overall success one-year post-surgery. These results were used to support FDA approval of i-FACTOR in this indication. i-FACTOR is also supported by three additional published peer-reviewed clinical studies from international usage. Recently, a second Level 1 investigational device exemption (IDE) study was initiated for use in transforaminal lumbar interbody fusion.