AngioDynamics announces FDA clearance of expanded indications for Auryon atherectomy system


AngioDynamics recently announced receiving Food and Drug Administration (FDA) 510(k) clearance of an expanded indication for the Auryon atherectomy system to include arterial thrombectomy.

The FDA recently cleared the expanded indication for the Auryon system’s 2mm and 2.35mm catheters to include adjacent thrombus aspiration when treating stenoses in native and stented infrainguinal arteries. Both catheters have aspiration capabilities as atherectomy devices, including in-stent restenosis (ISR).

The Auryon laser can be used to treat all infrainguinal lesion types, including above-the-knee (ATK), below-the-knee (BTK), and ISR, and to date, has been used to treat more than 21,000 patients in the U.S., a company press release reported.

“Combining the 2mm and 2.35mm Auryon laser atherectomy with the aspiration capability has changed our practice. We now treat acute limb ischemia in a single session where we remove the acute component as well as treat the underlying lesion. Patients are now discharged in less than 24 hours without the need for an ICU bed or overnight lysis,” said Carlos J. Guevara, MD, an interventional radiologist from Washington University School of Medicine in St Louis, Missouri.


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