AngioDynamics, Inc. announced that the United States Food and Drug Administration (FDA) has cleared the Auryon XL Catheter, a 225-cm radial access catheter, for use with the Auryon Atherectomy System in the treatment of Peripheral Arterial Disease (PAD). According to the American Heart Association, PAD affects 8.5 million Americans and 200 million people worldwide each year. Studies have shown that radial access is associated with a significantly lower risk of major bleeding and access site complications when compared to femoral access in the treatment of patients.

The Auryon XL Catheter, available in 0.9 mm and 1.5 mm diameters, expands treatment access points in atherectomy procedures for PAD. Use of a general radial access catheter may reduce incidents of major bleeding, when compared to femoral access, by more than 70%. Additionally, it may eliminate the need for the use of femoral closure devices and allow for the treatment of bilateral disease in a single session, supporting improved patient mobility, earlier discharge and faster patient recovery times.

Following FDA 510(k) clearance, AngioDynamics initiated a limited market release of the Auryon XL Catheter in the United States in January 2024 and expects to enter full market release in February 2024. The Auryon laser can be used to treat all infrainguinal lesion types, including above-the-knee (ATK), below-the-knee (BTK) and In-Stent Restenosis (ISR), and to date, it has been used to treat more than 50,000 patients7 in the United States. The technology underlying the Auryon Atherectomy System has been shown in clinical studies to be effective in treating lesions ranging from soft plaque to severely calcified5,6,8. The System uses a 355nm wavelength laser platform, enabling the use of short UV laser pulses with targeted biological reactions that are effective in treating PAD while minimizing the risk of perforation and preserving the ability to vaporize lesions without thermal ablation.