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Interventional Spine wins expanded clearance for Opticage spine implant

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Interventional Spine lands U.S. clearance for lumbar fusion device

Interventional Spine said it secured expanded 510(k) clearance from the FDA for its Opticage spine implant

The Irvine, Calif.-based company makes implants used in spine surgeries, with a focus on osteoporosis-afflicted bones. expandable interbody fusion device.

The clearance means Opticage, which has been on the market since early 2012, can be sold in additional 11 sizes. The device is used in lumbar fusion surgery, according to a press release.

“With this milestone, Interventional Spine continues the practice of partnering with top surgeons around the world in providing the best solutions for patients. These new sizes expand the application of Interventional Spine’s technology to significantly more patients and increase the market penetration of the Opticage. 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 12mm incision while protecting the surrounding nerves, which is unique in the world,” CEO Walter Cuevas said prepared remarks.

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