AngioDynamics’ Auryon XL Radial Access Catheter Receives FDA 510(k) Clearance

January 23, 2024—AngioDynamics, Inc. announced that the FDA has cleared the company’s Auryon XL catheter, a 225-cm radial access catheter, for use with the Auryon atherectomy system in the treatment of peripheral artery disease (PAD).

The company initiated a limited market release of the Auryon XL catheter in the United States in January 2024. It expects to enter full market release in February 2024.

The Auryon XL catheter is available in 0.9- and 1.5-mm diameters.

AngioDynamics noted that using a general radial access catheter may reduce incidents of major bleeding, compared to femoral access, by more than 70%. Additionally, it may eliminate the need for the use of femoral closure devices and allow for treating bilateral disease in a single session, supporting improved patient mobility, earlier discharge, and faster patient recovery times.

“Radial access is more than an entry point; it’s a transformative expressway to enhanced patient outcomes,” commented Ankur Lodha, MD, in the company’s press release. “With an innovative design and its ease-of-use, the Auryon XL catheter brings significant advancements to radial procedures as the first nonorbital atherectomy device—setting a new standard for laser atherectomy technology.” Dr. Lodha is an interventional cardiologist at the Cardiovascular Institute of the South in Lafayette, Louisiana.

According to the company, 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 calcified. The system uses a 355-nm wavelength laser platform, enabling the use of short ultraviolet 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.

The Auryon laser can be used to treat all infrainguinal lesion types, including above-the-knee, below-the-knee, and in-stent restenosis, noted AngioDynamics.