Business Wire 16-Jan-2020 11:00 AM
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 PATHFINDER I: Post-Market Registry (PATHFINDER I-Registry, EX-PAD-05), a pilot study to evaluate the safety and efficacy of the Company's AURYON Atherectomy System in the treatment of de novo, re-stenotic, and in-stent restenosis (ISR) lesions in infrainguinal arteries of patients with Peripheral Artery Diseases (PAD).
The AURYON Atherectomy System, previously known as the Eximo B-Laser, is a proprietary 355nm wavelength laser-technology platform that was acquired by AngioDynamics in October 2019.
"The PATHFINDER I study will provide valuable, scientifically backed data to further differentiate the AURYON system from competitive products in this space and build upon the excellent long-term results that patients experienced during the IDE," said Juan Carlos Serna, AngioDynamics Vice President for Clinical Affairs & Healthcare Economics.
AngioDynamics' PATHFINDER I Registry is a prospective, non-randomized, single arm, multicenter observational study that will evaluate the performance of the AURYON Atherectomy System during procedures and measure clinical outcomes, both intermediate and long-term. A total of 100 eligible PAD patients treated with the AURYON Atherectomy System in a post-market setting will be enrolled and tracked for a 36-month period after the initial procedure.
Initial findings from the pilot registry study will contribute to a subsequent large pivotal phase registry that is expected to include approximately 1,000 patients. Visit www.clinicaltrials.gov/ct2/show/NCT04229563 for more information about the PATHFINDER I Registry.
As previously communicated, the commercial release of the AURYON Atherectomy System in the United States will occur in the second half of AngioDynamics' current fiscal year. For more information about the AURYON Atherectomy System, visit Auryon-PAD.com for more 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.