AngioDynamics Announces FDA Clearance of Expanded Indications for Auryon Atherectomy System
Latham, New York, August 5, 2022 – 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 quality of life for patients, today announced that it has received 510(k) clearance of an expanded indication for the Auryon Atherectomy System to include arterial thrombectomy.
The United States Food and Drug Administration (FDA) recently cleared the expanded indication for the Auryon System’s 2.0mm and 2.35mm catheters to include adjacent thrombus aspiration when treating stenoses in native and stented infrainguinal arteries. Both catheters have aspiration capabilities as atherectomy devices, including in-stent restenosis (ISR).
“AngioDynamics is pleased to have received these expanded indications for the Auryon Atherectomy System,” said Scott Centea, Senior Vice President and General Manager, Global Endovascular Therapies. “Since launching commercially in September 2020, the Auryon Atherectomy System has become an essential tool for providers across the United States in the treatment of Peripheral Artery Disease (PAD) and related conditions. These expanded indications further validate the extensive capability and effectiveness of the Auryon technology offering our providers an advanced and efficient treatment option for PAD.”
The Auryon laser can be used to treat all infrainguinal lesion types, including above-the-knee (ATK), below-the-knee (BTK), and ISR1,2, and to date, has been used to treat more than 21,000 patients3 in the United States.
“Combining the 2.0mm and 2.35mm Auryon laser atherectomy with the aspiration capability has changed our practice. We now treat acute limb ischemia in a single session where we remove the acute component as well as treat the underlying lesion. Patients are now discharged in less than 24 hours without the need for an ICU bed or overnight lysis,” said Carlos J. Guevara, M.D., Mallinckrodt Institute of Radiology at the Washington University School of Medicine in St. Louis.
About the Auryon Atherectomy System
The Auryon Atherectomy System uses innovative technology to deliver powerful treatment of arterial occlusions. The Auryon Atherectomy System is the first laser atherectomy system to efficiently treat any lesion type, any lesion length, at any lesion location, with minimal impact on vessel walls1,4-6. The Auryon Atherectomy System uses solid-state laser technology for the treatment of PAD and is FDA cleared with an indication for treatment, including atherectomy, of infrainguinal stenoses and occlusions, including ISR1,2. The Auryon System’s targeted biological reactions minimize the risk of perforation and preserve the ability to vaporize lesions without thermal ablation7. The Auryon System uses a 355nm wavelength laser platform which enables the use of longer wavelengths and shorter pulses to produce a groundbreaking delivery of short UV laser pulses2. For more information, please visit www.Auryon-PAD.com. For important risk information, visit www.angiodynamics.com/about-us/risk-information/.
About AngioDynamics, Inc.
AngioDynamics is 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 quality of life for patients.
The Company’s innovative technologies and devices are chosen by talented physicians in fast-growing healthcare markets to treat unmet patient needs. For more information, visit www.angiodynamics.com.
AngioDynamics, the AngioDynamics logo, and Auryon are trademarks and/or registered trademarks of AngioDynamics, Inc., an affiliate or subsidiary. All other trademarks are property of their respective owners.
References
1. Rundback J, Chandra P, Brodmann M, Weinstock B, Sedillo G, Cawich I, et al. Novel laser-based catheter for peripheral atherectomy: 6-month results from the Eximo Medical B-LaserTM IDE study. Catheter Cardiovasc Interv. 2019;1-8.
2. Auryon System Indications for Use
3. AngioDynamics’ Fiscal 2022 Fourth Quarter Financial Results https://investors.angiodynamics.com/events/event-details/angiodynamics-fiscal-2022-fourth-quarter-financial-results
4. Herzog A, Bogdan S, Glikson M, Ishaaya AA, Love C. Selective tissue ablation using laser radiation at 355 nm in lead extraction by a hybrid catheter; a preliminary report. Lasers Surg Med. 2016;48(3):281-287.
5. Vogel A, Venugopalan V. Mechanisms of pulsed laser ablation of biological tissues. Chem Rev. 2003;103(2):577-644.
6. Akkus NI, Abdulbaki A, Jimenez E, Tandon N. Atherectomy devices: technology update. Med Devices (Auckl). 2015;8:1-10.
7. Taylor RS, Higginson LAJ, Leopold KE. Dependence of the XeCl laser cut rate of plaque on the degree of calcification, laser fluence, and optical pulse duration. Lasers Surg Med. 1990;10(5):414-419.
Investor Relations Contact:
Stephen Trowbridge
518-795-1408
strowbridge@angiodynamics.com
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Saleem Cheeks
518-795-1174
scheeks@angiodynamics.com