AngioDynamics Announces FDA 510(k) Clearance Of Auryon XL Radial Access Catheter To Treat Peripheral Arterial Disease

Author: Benzinga Newsdesk | January 23, 2024 09:15am

225-cm Catheter Length Expands Access Points in Atherectomy Procedures to Help Reduce Access Site Complications and Accelerate Patient Recovery

AngioDynamics, Inc. (NASDAQ:ANGO), a leading and transformative medical technology company focused on restoring healthy blood flow in the body's vascular system, expanding cancer treatment options and improving patient quality of life, today announcedthat 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 year1. Studies have shown that radial access is associated with a significantly lower risk of major bleeding and access site complications when compared to femoral access2,3 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, Inc. "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."

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%3. 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," said Ankur Lodha, M.D., interventional cardiologist at Cardiovascular Institute of the South located 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."

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)5,6,8,11, 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 ablation5,8-10.

For important risk information, visit www.angiodynamics.com/about-us/risk-information/.

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