Business
AngioDynamics Announces FDA 510(k) Clearance of Auryon XL Radial Access Catheter to Treat Peripheral Arterial Disease
225-cm Catheter Length Expands Access Points in Atherectomy Procedures to Help Reduce Access Site Complications and Accelerate Patient Recovery LATHAM,
About this update from Angiodynamics, Inc.
[{"type":"text","content":"\n225-cm Catheter Length Expands Access Points in Atherectomy Procedures to Help Reduce Access Site Complications and Accelerate Patient Recovery\n\n\n LATHAM, N.Y.--(BUSINESS WIRE)--\nAngioDynamics, 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 announced that 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).\n\n\nAccording 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.\n\n\n“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.”\n\n\nThe 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.\n\n\n\"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 Aury...