Cutting Edge Spine has received FDA 510(k) clearance for its EVOS System. The system, according to the press release, offers an array of interbody implants manufactured with polymers known as Peek-Optima Natural and Peek-Optima HA Enhanced.
FDA Clears Cutting Edge Spine’s Implants
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“With the approval of the EVOS system, we are proud to be first-to-market in the U.S. with an HA [hydroxyapatite] enhanced Peek Lumbar Interbody system, ” said Randy Roof, president of Cutting Edge Spine. “The innovative polymer, Invibio’s Peek-Optima HA Enhanced, has been compounded with hydroxyapatite, an osteoconductive material, to enhance bone apposition. Our partnership with Invibio made it possible, and was key to obtaining FDA clearance, ” he added.
John Devine, M.D., Director of Invibio Biomaterial Solutions, said, “Supporting Cutting Edge Spine in every phase of the development of the new clinically impactful EVOS system now entering the U.S. market, also allowed us to contribute to a solution that we believe will have positive impact on the quality of life of patients with clinical conditions.”
John Souza, Sr., Director of Research and Development at Cutting Edge Spine said that the firm was providing surgeons with 3, 714 lumbar implant options, and hospitals with single use, bar coded, and pre-sterilized packaging. Roof said that being able to offer “the largest range of footprints in the market is truly a game changer.”
Founded in 2009, Cutting Edge Spine is a privately owned organization headquartered in Waxsah, North Carolina.
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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