Pinnacle Spine Group has announced the CE Mark (Conformité Européenne) approval for its entire line of InFill Interbody Devices, as well as its patented InFill Graft Delivery System. Pinnacle’s line of interbody devices includes the InFill Direct Lateral system, the InFill Lordotic Oblique TLIF, the InFill Convex Oblique TLIF, the InFill Contour Oblique TLIF, the InFill ALIF, and the InFill Cervical Lordotic, and InFill Anatomic interbody devices.
Pinnacle Spine: CE Marks Rolling In
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Pinnacle also received CE Mark approval for its novel InFill Graft Delivery System, which initial studies have shown can place up to 94% more biologic between the vertebral bodies using the lateral approach than traditional prepacking of the implant
Zach Sowell, vice president of marketing for Pinnacle Spine, told OTW, “As for our plans for the European market, we are currently in discussions with a handful of distributors, and we will be in Lyon, France, for Eurospine. It is during this trip that we plan to hold a small meeting with our signed distributors to discuss plans for growing our footprint overseas.”
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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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