New Clinical Study to Assess Auryon Atherectomy Treatment in Below-the-Knee Arteries
Latham, New York, April 14, 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 the launch of a new clinical study assessing the use of their Auryon Atherectomy System in the treatment of calcified lesions in below-the-knee (BTK) arteries. The study is an investigator-initiated trial which will be conducted by the Midwest Cardiovascular Research Foundation under the guidance of Principal Investigator Nicolas Shammas, MD.
The prospective, multi-center, single-arm study will evaluate the safety and procedural effectiveness of the Auryon System in treating infrapopliteal disease in patients with critical limb ischemia (Rutherford 4 and 5). The study will enroll 60 subjects and will be conducted at up to four sites in the United States. Patients will be assessed at 30 days, and three, six, and 12 months post-treatment. The primary safety endpoint is defined as a composite of Major Adverse Limb Events (MALE) and Post-Operative Death (POD) at 30 days. The primary performance endpoint is procedural success: ≤ 30% residual stenosis for the treated vessel segment without serious angiographic complications after final treatment – this will be adjudicated via angiographic core lab. Secondary endpoints include primary patency at six and 12 months and Clinically-Driven Target Lesions Revascularization (CD-TLR) at 30 days, and three, six and 12 months.
“We are grateful to Dr. Shammas, the Midwest Cardiovascular Research Foundation, and our study partners,” said Juan Carlos Serna, Sr. VP, Scientific & Clinical Affairs, AngioDynamics. “Since launching commercially in late 2020, the Auryon System has gained rapid adoption across the United States as a minimally invasive treatment for peripheral artery disease, in-stent restenosis, and related conditions. We anticipate that this study will further strengthen and confirm the versatility and efficacy of this innovative technology platform, while effectively treating patients and helping to improve their quality of life.”
“The Auryon laser is uniquely suited to treat tibial vessels in limb ischemia patients all the way into the pedals,” said Dr. Shammas, Principal Investigator of this study and Founder and Research Director, Midwest Cardiovascular Research Foundation. “It has been shown to treat all types of plaque morphology including severe calcium and demonstrated excellent luminal area gain following adjunctive balloon angioplasty with a low incidence of flow limiting dissections and need for bailout stenting. The multicenter prospective Auryon System BTK study will evaluate procedural and technical success and the need for bailout stenting post-treatment in the tibial vessels and determine the presence and depth of dissections using intravascular ultrasound. Sparing the deeper layers of the vessel wall while obtaining optimal luminal gain may yield good patency and freedom from target lesion revascularization at 1 year follow-up.”
“We are very excited to start enrolling in the Auryon System Below-the-Knee study,” said Warren Swee, MD, MPH, Chief Medical Officer, Palm Vascular Centers. “This study will further investigate the role of laser atherectomy using a 355nm wavelength short-pulse laser in the tibial arteries of critical limb ischemia patients. The small size of these vessels with long-segment and heavily calcified disease has been a challenge to treat with other atherectomy devices. We are interested to see if the Auryon laser will fare better given its low profile and early data suggesting the ability to effectively treat a variety of plaque types.”
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. 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 ISR4,6. The Auryon System’s targeted biological reactions address the risk of perforation and preserve the ability to vaporize lesions without thermal ablation5. 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. 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.
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3 Akkus NI, Abdulbaki A, Jimenez E, Tandon N. Atherectomy devices: technology update. Med Devices (Auckl). 2015;8:1-10.
4 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.
5 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.
6 Auryon System Indications for Use
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