Interventional Spine, Inc, a privately held company based in Irvine, California, reports the receipt of FDA clearance of their next generation expandable interbody fusion device called Opticage.
FDA Clears Interventional Spine’s Opticage Device
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Company officials say that the new Opticage features an improved ability to deliver graft material through the implant after expansion, has a new streamlined profile and improved ergonomics.
Interventional Spine plans to provide several sizes of the new design in sterile packaging to address the most commonly used surgical approaches to spinal fusion. Since the market release in mid-2012 of the original Opticage, the company claims that there have been close to 2, 000 implants worldwide “with exceptional clinical results.”
Interventional Spine Chief Executive Officer Walter A. Cuevas said: “This represents another milestone for Interventional Spine as we continue to bring innovative surgical solutions to the spine market to address the needs of patients and surgeons worldwide.” He added that Interventional Spine expects to begin shipping the new Opticage in January 2016.
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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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