AngioDynamics Announces Commercial Launch of Auryon Atherectomy System in United States
ADVANCED MEDICAL TECHNOLOGY SAFELY1 & EFFECTIVELY TREATS PAD, CLI, 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
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
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
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/.
- 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
- 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
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.