Dom Coric, M.D. of Carolina Neurosurgery and Spine Associates, has successfully implanted the 100th FLXfit 3D expandable cage.
100th FLXfit Expandable Cage Implanted
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Expanding Orthopedics Inc., the Akiva, Israel-based company that manufactures the device announced FDA clearance of the device last summer. The first surgery using the FLXfit was performed last December by John Peloza, M.D. at the Texas Back Institute.
Creating Lordosis
Peloza said the device was an improvement because it covers a large surface area of the disc space and it expands in the front of the disc space, creating lordosis. He said what makes the device unique is that it can “go in through a tube. Therefore, it works with a very minimally invasive approach, allowing for less muscle damage and quicker recovery for the patient.”
Expanding Orthopedics CEO Ofer Bokobza said on June 5, 2015 that the device can be used in open or minimally invasive surgery (MIS) techniques. He was also “extremely excited” by the fast acceptance of the device in the U.S. market, “with a growing number of surgeons adopting it as their preferred IBFD (interbody fusion device).
Coric said he has been using expandable cages for many years and has found the FLXfit to be a “great alternative” for his TLIF (transforaminal lumbar interbody fusion) surgeries.
The device offers an “articulated, self-guided design with large, anterior type, footprint coupled with a unique expansion mechanism to restore lordosis angle and tight anatomical fit. In addition, its unique shape and anterior positioning enables ample space for pre- and post-, bone graft packing, ” said Coric.
He likes the in-situ lordotic expansion which, he says, allows for restoration of the disc height, segmental lordosis and overall sagittal balance. Coric thinks that devices like the FLXfit “could create a shift in the way surgeons and patients will look at fusion procedures. It’s a dramatic evolution from locking the patient’s anatomy at a given state using static spacers towards reconstructing the patient’s optimal anatomy using devices which combine large footprint support with in-situ lordosis correction.”
To see the device being implanted, click here.
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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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