AngioDynamics, Inc. Launches PATHFINDER I Registry to Evaluate Performance and Clinical Outcomes of the AURYON™ Atherectomy System
January 16, 2020 at 04:00 pm
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AngioDynamics, Inc. 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. 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. 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.
AngioDynamics, Inc. is a transformative medical technology company. The Company is focused on restoring healthy blood flow in the body's vascular system, expanding cancer treatment options and improving quality of life for patients. It designs, manufactures, and sells a range of medical, surgical and diagnostic devices used by professional healthcare providers for vascular access, for the treatment of peripheral vascular disease and for use in oncology and surgical settings. Its devices are generally used in minimally invasive, image-guided procedures. Its segments include Med Tech and Med Device. Its product categories include oncology, venous therapies, vascular interventions, and ports. Its oncology products include Model 1500X RF Generator, IsoLoc Endorectal Balloon, Habib 4X Laparoscopic Bipolar Resection Device, Habib 4X Bipolar Resection Device, and Alatus. Its venous therapies include VenaCure EVLT 1470 Pro Laser, VenaCure EVLT System, VenaCure EVLT Procedure Packs, and others.