AngioDynamics’ Auryon Atherectomy System Receives FDA Clearance of Expanded Indication

August 9, 2022—AngioDynamics, Inc. announced that it has received FDA 510(k) clearance of an expanded indication for the Auryon atherectomy system to include arterial thrombectomy.

The company noted that the FDA recently cleared the expanded indication for the Auryon system’s 2- and 2.35-mm 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 company announced the launch of the Auryon atherectomy system in September 2020.

According to AngioDynamics, the Auryon laser can be used to treat all infrainguinal lesion types, including above-the-knee, below-the-knee, and ISR. To date, the device has been used to treat more than 21,000 patients in the United States.

“Combining the 2- and 2.35-mm Auryon laser atherectomy with the aspiration capability has changed our practice,” commented Carlos J. Guevara, MD, in the company’s press release. “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.” Dr. Guevara is from the Mallinckrodt Institute of Radiology at the Washington University School of Medicine in St. Louis, Missouri.