AngioDynamics Receives FDA Clearance of Auryon XL Radial Access Catheter to Treat Peripheral Arterial Disease

AngioDynamics has received the US FDA clearance of 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) which affects 8.5 million Americans and 200 million people worldwide each year. 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 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.

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,” said Kimberly Nelson, Senior Director of Auryon Global Marketing at AngioDynamics. “Our entry into the Radial-to-Peripheral (R2P) 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.”

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