France was the setting for the first-ever surgery performed with Expanding Orthopedics’ FLXfit 3D Expandable Interbody Cage, the world’s first 3D expandable interbody cage. The surgery was performed by Professor Jean-Charles Le-Huec, Head, Ortho-Spine Department, Bordeaux University Hospital, France and Former President of the European Spine Society and the International Society of Advanced Spinal Surgery. In the September 2, 2014 news release, Professor Le-Huec said, “I am very excited to start using the FLXfit product as it combines several critical features that are important clinically: large footprint coverage cage that can be inserted in a regular or a minimal invasive way and then expanded to fit the patient’s anatomy, making it a very useful tool in our daily practice. The big difference with existing devices is the FLXfit’s ability to combine the above-mentioned features with lordosis angle correction, which can help restore the sagittal balance, which is crucial for a successful fusion procedure. We will need to perform additional cases and have a longer follow-up but I believe that the FLXfit represent a class of devices that may change the way spine surgeons treat their patients in the future.”
Expanding Orthopedics: First Ever Surgery With FLXfit
Ofer Bokobza, CEO of Expanding Orthopedics, said, “I am extremely honored that Prof. Le Huec, a world renowned spine KOL, and his dedicated team at the Centre Hospitalier Universitaire de Bordeaux, were part of this exciting and important milestone. We see an increased interest and fast momentum building with this product; we have scheduled surgeries this month in Germany, followed by start of surgeries in the U.S. during the month of September which will represent our initial entry into the U.S. market. We are in the process of signing additional distributors in the US and expect a very fruitful and exciting year.”
Bokobza told OTW, “We are signing our first distribution agreement in the U.S. and in the next 12 months we are expecting to build a significant sales channel in the U.S. and generate significant momentum with device usage. We are confident that the FLXfit will be established as a new breed of innovative products and will gain a leading position as new standard of care in interbody fusion.”
Discussion
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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