AngioDynamics recently announced that it has received US 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).
“AngioDynamics is pleased to have received these expanded indications for the Auryon atherectomy system,” said Scott Centea, senior vice president and general manager, Global Endovascular Therapies. “Since launching commercially in September 2020, the Auryon atherectomy system has become an essential tool for providers across the USA in the treatment of peripheral arterial disease (PAD) and related conditions. These expanded indications further validate the extensive capability and effectiveness of the Auryon technology offering our providers an advanced and efficient treatment option for PAD.”
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 USA, a company press release reports.
“Combining the 2mm and 2.35mm Auryon laser atherectomy with the aspiration capability has changed our practice. We now treat acute limb ischaemia 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 (Washington University School of Medicine, St Louis, USA).