AngioDynamics Receives FDA 510(k) Clearance For Auryon XL Catheter

(RTTNews) - AngioDynamics, Inc. (ANGO) announced on Tuesday that it has received FDA 510(k) clearance for the Auryon XL Catheter, a 225-cm radial access catheter designed for use with the Auryon Atherectomy System in treating Peripheral Arterial Disease (PAD).

Following FDA clearance, the company plans to launch a limited market release of the Auryon XL Catheter in the United States in January 2024, with a full market release expected in February 2024.

Kimberly Nelson, Senior Director of Auryon Global Marketing at AngioDynamics, Inc., commented that the Auryon Atherectomy System has significantly impacted patient treatment for PAD since its introduction in September 2020, and has become an essential tool for providers and patients due to its innovative solid-state laser technology.

The company's Auryon XL Catheter, which comes in 0.9 mm and 1.5 mm sizes, expands the access points for atherectomy procedures in the treatment of PAD and has the potential to eliminate the requirement for femoral closure devices and allows for the treatment of bilateral disease in a single session, promoting improved patient mobility, earlier discharge, and faster recovery times.