Announcements

AngioDynamics Announces Commercial Launch of Auryon Atherectomy System in United States

   12:09 AM - 21 Sep 2020

ADVANCED MEDICAL TECHNOLOGY SAFELY1 & EFFECTIVELY TREATS PAD, CLI, ISR 

AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, today announced the launch of the Auryon Atherectomy System, a newly-developed innovative technology for the treatment of Peripheral Artery Disease (PAD),including Critical Limb Ischemia (CLI) and In-Stent Restenosis (ISR).

The Auryon Atherectomy System uses revolutionary technology to deliver powerful treatment of PAD lesions and occlusions. The Auryon Atherectomy System is the first laser atherectomy system to efficiently treat lesions of any type, length, or location (above and below the knee), with minimal impact on vessel walls1. The Auryon Atherectomy System uses solid-state laser technology for the treatment of PAD and is FDA cleared with an indication for treatment of infrainguinal stenoses and occlusions, including ISR.

“We strongly believe the Auryon Atherectomy System is a game-changer for the treatment of PAD, representing a true technological advancement in the treatment of these widespread and potentially fatal conditions,” said Jim Clemmer, AngioDynamics’ President and CEO. “We have already seen a very positive response from initial users of the Auryon System, which has led to a rapid expansion of markets and geographies. AngioDynamics is proud to make the Auryon Atherectomy System, and its solid-state laser technology, available to providers and patients nationwide.”

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 calcified1,2. 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 ablation3,4. During the Auryon Atherectomy System pivotal trial, 0% target lesion revascularization (TLR) was shown at 6 months2 after receiving treatment for ISR.

"Over the past 20 years, there has been a tremendous increase in endovascular techniques to treat peripheral artery disease (PAD), particularly in cases that might have otherwise required an amputation,” said Venkatesh Ramaiah, MD. “The Auryon Atherectomy System for infrainguinal lesions and in-stent restenosis has yielded excellent results without perforations, embolization, or other major complications. The solid-state, longer-wavelength and shorter-pulse approach differentiates the Auryon laser as a more efficient option across a wide range of plaque morphologies. This technology has the potential to save limbs and generally improve the quality of life for patients suffering from PAD.”

The Auryon Atherectomy System features aspiration and off-set capability in certain catheter sizes, allowing clinicians to address the risk of embolization and to treat all lesion types1, while answering a need for non-surgical intervention options for PAD, including ISR, and CLI. According to the American Heart Association, PAD affects 8.5 million Americans and 200 million people worldwide each year5.

The launch of the Auryon Atherectomy System is supported by the launch of Auryon-PAD.com. On the site, visitors can learn about the science behind the Auryon Atherectomy System, read recent case studies, and access videos to explore the technology behind the Auryon Atherectomy System.

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

About AngioDynamics, Inc.

AngioDynamics, Inc. is a leading provider of innovative, minimally invasive medical devices used by professional healthcare providers for vascular access, peripheral vascular disease, and oncology. AngioDynamics’ diverse product lines include market-leading ablation systems, vascular access products, angiographic products and accessories, drainage products, thrombolytic products and venous products. For more information, visit www.angiodynamics.com.

References:

1.Rundback J, Chandra P, Brodmann M et al. Novel laser?based catheter for peripheral atherectomy: 6?month results from the Eximo Medical B?Laser™ IDE study. Catheterization and Cardiovascular Interventions. 2019;94(7):1010-1017. doi:10.1002/ccd.28435

2.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

3.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

4.Vogel A, Venugopalan V. Mechanisms of pulsed laser ablation of biological tissues. Chem Rev. 2003;103(2):577-644

5.American Heart Association - PAD Resources. www.heart.org. https://www.heart.org/en/health-topics/peripheral-artery-disease/pad-resources. Published 2019. Accessed July 27, 2020.

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Investor Relations:
AngioDynamics, Inc.
Stephen Trowbridge
518-795-1408
strowbridge@angiodynamics.com

Media
AngioDynamics, Inc.
Saleem Cheeks
518-795-1174
scheeks@angiodynamics.com

Source: AngioDynamics, Inc.