The company received FDA clearance for the FLXfit in July. It is the world’s first three-dimensional expandable interbody cage cleared for commercialization in the United States. The cage is designed for minimally invasive spine surgery and maximum footprint support.
Prof. Jean-Charles Le Huec performed the first procedure. The company also plans the first distribution agreement in the United States — and the first U.S. procedure — soon. Dr. Le Huec presented a paper at the International Society for the Advancement of Spine Surgery annual meeting on the FLXfit.
“The current cages available on the market have limited possibilities for lordosis correction and are sometimes difficult to maneuver,” said Dr. Le Huec. “In addition, the contact between the implant and endplate is not always optimal, leading to improper stability after surgery.”
The FLXfit allows for a wide anterior footprint coverage in minimally invasive, unilateral TLIF approaches. It has articulated self-guidance features for optimal placement after expansion.
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