Business Wire10.28.20
AngioDynamics Inc., a provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, has launched 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 walls.1 The Auryon Atherectomy System uses solid-state laser technology for the treatment of PAD and is U.S. Food and Drug Administration-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 calcified.1,2 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 ablation.3,4 During the Auryon Atherectomy System pivotal trial, 0 percent target lesion revascularization (TLR) was shown at six 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, M.D. “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 types,1 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 year.5
AngioDynamics’ product lines include ablation systems, vascular access products, angiographic products and accessories, drainage products, thrombolytic products and venous products.
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.
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 walls.1 The Auryon Atherectomy System uses solid-state laser technology for the treatment of PAD and is U.S. Food and Drug Administration-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 calcified.1,2 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 ablation.3,4 During the Auryon Atherectomy System pivotal trial, 0 percent target lesion revascularization (TLR) was shown at six 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, M.D. “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 types,1 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 year.5
AngioDynamics’ product lines include ablation systems, vascular access products, angiographic products and accessories, drainage products, thrombolytic products and venous products.
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.
