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FDA clears additional sizes of interbody fusion device

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Interventional Spine Inc. announced the FDA clearance of eleven additional sizes of the Opticage Expandable Interbody Fusion Device, allowing surgeons to match an Expandable Opticage to more than 80% of patients requiring lumbar fusion surgery.

According to a company press release, the fusion device features a continuously adjustable height within a working range of 9 mm to 14 mm.

“These new sizes expand the application of Interventional Spine’s technology to significantly more patients and increase the market penetration of the Opticage,” Walter A. Cuevas, chief executive officer of Interventional Spine, stated in the release. “In addition, due to its unique expansion properties, the Opticage Expandable Interbody Fusion Device provides an excellent alternative to surgeons performing lumbar interbody fusions, whether via percutaneous or MIS procedures. In fact, in combination with Interventional Spines’ PerX360 technology, the Opticage gives the surgeon the capability of performing a lumbar interbody fusion via a 12-mm incision while protecting the surrounding nerves, which is unique in the world.”