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
According to the
“Since its launch in
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
Following FDA 510(k) clearance,
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 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/.
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 walls5,8-10. 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 ISR6,11. The Auryon System’s targeted biological reactions minimize the risk of perforation and preserve the ability to vaporize lesions without thermal ablation5,8-10. 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 pulses6. For more information, please visit www.Auryon-PAD.com.
About
Founded by Dr.
About
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.
Safe Harbor
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements regarding AngioDynamics’ expected future financial position, results of operations, cash flows, business strategy, budgets, projected costs, capital expenditures, products, competitive positions, growth opportunities, plans and objectives of management for future operations, as well as statements that include the words such as “expects,” “reaffirms,” “intends,” “anticipates,” “plans,” “believes,” “seeks,” “estimates,” “projects,” “optimistic,” or variations of such words and similar expressions, are forward-looking statements. These forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties. Investors are cautioned that actual events or results may differ materially from AngioDynamics’ expectations, expressed or implied. Factors that may affect the actual results achieved by
References
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American Heart Association - PAD Resources. www.heart.org. https://www.heart.org/en/health-topics/peripheral-artery-disease/pad-resources. Published 2021. AccessedJanuary 12, 2024 . -
KHAN, B., KHAN, A., MUHAMMAD , A., SAWAR , S., RAHMAN , F., & HASSAN , M. (2023). COMPARISON OF THE EFFECTIVENESS OF RADIAL VERSUS FEMORAL ACCESS FOR DIAGNOSTIC AND THERAPEUTIC PROCEDURES IN PATIENTS WITH PERIPHERAL ARTERIAL DISEASE.
Biological and Clinical Sciences Research Journal , 2023(1), 244. https://doi.org/10.54112/bcsrj.v2023i1.244 - Jolly SS, Amlani S, Hamon M, Yusuf S, Mehta SR. Radial versus femoral access for coronary angiography or intervention and the impact on major bleeding and ischemic events: a systematic review and metaanalysis of randomized trials. Am Heart J. 2009;157(1):132
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Kern MJ. Radial Access in Practice. Tips for starting a successful program. Cardiac Interventions Today. September/
October 2015 . - 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.
- Auryon System Indications for Use
- AngioDynamics’ J.P. Morgan Healthcare Conference Presentation https://investors.angiodynamics.com/static-files/35c51c12-b962-40b5-b349-22341e0d859b. Published 2024.
- Shammas NW, Chandra P, Brodmann M, Weinstock B, Sedillo G, Cawich I, et al. Acute and 30-day safety and effectiveness evaluation of Eximo Medical’s B-LaserTM, a novel atherectomy device, in subjects affected with infrainguinal peripheral arterial disease: Results of the EXPAD-03 trial. Cardiovas Revasc Med. 2020;21(1):86-92
- 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
- Vogel A, Venugopalan V. Mechanisms of pulsed laser ablation of biological tissues. Chem Rev. 2003;103(2):577-644
- Built-in aspiration available only with the 2.0- and 2.35-mm catheters.
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