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Eximo Medical’s Atherectomy Laser Cleared by FDA

October 8, 2018

The FDA granted 510(k) clearance for Eximo Medical’s B-Laser atherectomy system, used for treating patients with peripheral artery disease, including in-stent restenosis.

The device — the first 355nm laser system cleared in the U.S. — is used in atherectomy procedures, minimally invasive procedures that remove atherosclerosis from a patient’s blood vessels.

Atherectomies offer an alternative to angioplasties, which involve inflating temporary balloons to widen and unclog arteries.

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