The 225-cm catheter length expands access points in atherectomy procedures to help reduce access site complications and accelerate patient recovery.

The United States Food and Drug Administration (FDA) has granted 510(k) clearance to AngioDynamics’ 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.

“Since its launch in September 2020, the Auryon Atherectomy System, with its innovative solid-state laser technology, has fundamentally changed patient treatment for PAD and quickly become an essential tool for providers and patients,” says Kimberly Nelson, senior director of Auryon global marketing at AngioDynamics, in a release. “Our entry into the radial-to-peripheral space with Auryon XL is an important part of our focus on advancing the quality of care delivery and it demonstrates our commitment to meeting the unmet needs of patients and atherectomy providers.”

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.

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

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 , below-the-knee, and in-stent restenosis. 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 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.

Photo caption: Auryon XL Catheter

Photo credit: AngioDynamics