Israeli spine technology company Expanding Orthopedics Inc. (EOI) received the CE (European Conformity) mark for FLXfit 15, its next generation expandable spinal cage.
EOI: CE Mark for Next Generation Expanding Spine Cage
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Notably, FLXfit 15 expands up to 4mm and gives the surgeon the ability to control lordosis correction of up to 15 degrees. There are two linear length options; a 40mm and a 32mm version.
Ofer Bokobza, chief executive officer of Expanding Orthopedics, commented to OTW, “The higher range expansion will enable surgeons to better treat their patients and restore lordosis angle up to 15 degrees. In addition, the 32mm length option will offer great flexibility in treating patients with smaller anatomies. The ability to deliver the largest, in-class, TLIF [transforaminal interbody lumbar fusion], expandable cage with 4mm height expansion and 15 degrees of lordosis correction through a small unilateral tube is a paradigm change in the MIS [minimally invasive surgery] fusion market.”
Mr. Bokobza went on to say: “Extending a family of a very successful product which is truly differentiated and being able to stretch the envelope again to provide even better solution is very exciting for us. Based on the experience we had with the FLXfit we are introducing the FLXfit 15 which will provide better flexibility with a smaller length size as well as better fit for patients’ unique anatomy by enabling a higher degree of lordosis correction.”
When asked about EOI’s longer term product vision, Mr. Bokobza said; “Expandable cages are gaining market momentum and play a key role in successful MIS fusion procedures. The FLXfit 3D expandable cage introduced a new paradigm with expandable cages and is already making a significant traction in the market place. We are thrilled with the release of the FLXfit 15 as it represents our continued commitment for innovation and ability to deliver state-of-the-art spine fusion solutions.” He concluded, “We believe that the versatility of the new FLXfit family will help EOI gain a greater share in the fusion surgery market both in MIS and open approaches.”
And for the U.S.? “We are in the midst of the FDA process and are excited to offer the product in the U.S.”
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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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