The FDA has issued a 510 (k) clearance for Integra LifeSciences Holding Corporation’s Hollywood NanoMetalene Interbody Device (IBD). The IBD is to be used primarily for transforaminal lumbar interbody fusion.
Integra Goes “Hollywood” Intervertebrally
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According to the October press release, “The PEEK-OPTIMA polymer used in the Hollywood NanoMetalene IBD underwent a proprietary high-energy, low temperature surface process that created a titanium coating around the implant, including the graft window. Company officials say that the ultrathin coating does not affect postoperative imaging and the surgeon’s ability to view the operative area and determine the extent of the vertebral body fusion.”
In its press release the company reported that it expects to begin a controlled U.S. release of the interbody device this year. Kirt Stephenson, president of U.S. Spine at Integra LifeSciences, stated, “Surgeons prefer the surface characteristics of titanium and the mechanical properties and radiolucency of PEEK-OPTIMA, and the Hollywood NanoMetalene IBD offers a treatment option that incorporates both benefits into one device.”
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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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