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FDA clears AngioDynamics’ Auryon XL catheter

January 23, 2024 By Danielle Kirsh

Auryon atherectomy system
Auryon atherectomy system [Image courtesy of AngioDynamics]
AngioDynamics announced today that it received FDA 510(k) clearance for its Auryon XL catheter for use with the Auryon atherectomy system in treating peripheral arterial disease (PAD).

The Auryon XP catheter is a 225 cm radial access catheter available in 0.9 mm and 1.5 mm diameters to expand treatment access points in atherectomy procedures in PAD.

“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.”

According to the company, a general radial access catheter could reduce major bleeding incidents by more than 70% compared to femoral access. It could also eliminate the need for femoral closure devices and allow for treating bilateral disease in a single session to support improved patient mobility, earlier discharge and faster patient recovery times.

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.

“Radial access is more than an entry point; it’s a transformative expressway to enhanced patient outcomes,” said Dr. Ankur Lodha, an interventional cardiologist at Cardiovascular Institute of the South in Lafayette, Louisiana. “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.”

AngioDynamics initiated a limited market release following the FDA clearance and expects to enter full market release in February.

Filed Under: Catheters Tagged With: AngioDynamics

About Danielle Kirsh

Danielle Kirsh is an award-winning journalist and senior editor for Medical Tubing + Extrusion, Medical Design & Outsourcing and MassDevice. She received her bachelor's degree in broadcast journalism and mass communication from Norfolk State University and is pursuing her master's in global strategic communications at the University of Florida. You can connect with her on Twitter and LinkedIn, or email her at dkirsh@wtwhmedia.com.

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