Becker's Spine Review

18 Executive Briefing clinical outcome in a controlled trial — "it was a very easy next step to take," Dr. Wright said. i-FACTOR Bone Graft was also compelling to Dr. Wright because of how it worked. Combining an osteogenic cell binding peptide (P-15) with a proven carrier to promote bone growth struck him as "a powerful intellectual idea," free of the safety concerns linked to other growth-factor products. Its unique mechanism of action attracts osteogenic cells in the surrounding tissues, which then attach via cellular surface receptor integrins to the P-15 Peptide, similar to a lock and key. The mechanical attachment activates (unlocks) multiple molecular processes that drive bone formation. Comparing fusion rates, safety The kind of evidence Cerapedics furnished for i-FACTOR Bone Graft isn't easy to obtain. In the absence of high-level regulatory requirements around bone graft substitutes, most manufacturers don't go beyond demonstrating safety in a lab environment with animal long bone, Dr. Deol and Dr. Wright said. "There's not a lot of products out there [that] have this level of data. That's why I chose Cerapedics; I think that's the strength of the product," Dr. Wright said. Cerapedics followed a stringent investigational device exemption pathway to make i-FACTOR Bone Graft the only other drug-device combination in the same regulatory class as BMP — which the FDA issued a public health warning against its use in the cervical spine, after surgeons reported complications of respiratory distress, reintubation and death in anterior cervical spine cases. A fair comparison to other bone graft substitutes, however, isn't so simple, considering the wide variation in mechanisms of action, levels of approval, side effect profiles and more. To address the lack of clarity as to how the devices stack up against one another, in January 2019, the International Society for the Advancement of Spine Surgery proposed six major categorizations of bone graft substitutes: nonstructural allograft, demineralized bone grafts, cellular allografts, synthetic bone grafts, autologous cellular grafts, and Class III drug-device combination products. "Bone grafting is an essential part of spinal surgery and an ever-evolving science," ISASS said. "With each new advance, one needs to understand the characteristics of the material, its mechanism of action, the regulatory pathway by which it came to market, and the preclinical and human clinical evidence available on which to base a clinical use decision." Landing in the Class III grouping further underscored i-FACTOR Bone Graft's advantages, according to Dr. Wright. According to Dr. Wright, i-FACTOR has a well-established safety profile based on Level 1 data. "If you really believe that human spine data is the most important criterion for selecting a spine product … [i-FACTOR Bone Graft] is the only product that meets that criteria with an outstanding safety record," he said. The claims hold up in practice In the 325 cases where Dr. Wright has used i-FACTOR Bone Graft, two benefits have stood out to him the most. "One, it works," he said. "The fusion rates are better than I have seen previously with just a synthetic substitute. Two, the safety profile is absolutely exemplary. I haven't had a single complication of swelling, unintended bone growth or any other complication with i-FACTOR Bone Graft." Due to these results — and despite countless pitches from other vendors — Dr. Wright has finally reached a point where he's not on the hunt for any other products or the "next generation." Moreover, he said, i-FACTOR Bone Graft is a viable option for outpatient facilities where ACDF procedures are increasingly performed. Whereas some bone graft substitutes have to be harvested, soaked or otherwise prepared, i-FACTOR Bone Graft takes no time to set up. "For ease-of-use for that ASC, to do those rapid, efficient cases, it hits all the boxes," Dr. Wright said. Despite Cerapedics' investment in the expensive IDE pathway, i-FACTOR Bone Graft provides a lower-cost alternative to growth factors. More importantly, the product's good fusion rates help curtail future costs — which is especially important for facilities participating in bundled payment contracts. "The largest economic impact would be having to redo a fusion," Dr. Deol said. "Downstream, if that inexpensive bone graft doesn't ultimately work, then you just doubled the cost." With Advisory Board projecting that U.S. healthcare spending will surpass $4 trillion in 2020 — and climb to more than $6 trillion by 2028 — managing costs is just one aspect of a surgeon's responsibility, but it's an increasingly pressing one. If such massive figures can be boiled down to one imperative, it's this: identifying the right setting, product and clinical approach for every patient. "We have an obligation, as users or surgeons, to help the healthcare systems decide which products should be paid for, and which are maybe not worth the amount that's been charged," Dr. Wright said. "Even though those other products don't have the same proven efficacy and safety, i-FACTOR Bone Graft has that — and is economically more suitable for an ASC setting." n 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.

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