January 16, 2020
PATHFINDER I Registry Will Study AngioDynamics’ Auryon Atherectomy System
January 16, 2020—AngioDynamics, Inc. announced the launch of the PATHFINDER I postmarket registry, which will enroll a total of 100 patients with peripheral artery disease (PAD) treated with the company’s Auryon atherectomy system in a postmarket setting with 36-month follow-up. The Auryon system is the company’s 355-nm wavelength laser-technology platform.
According to the company, the PATHFINDER I registry (also registered as EX-PAD-05) is a prospective, nonrandomized, single-arm, multicenter observational study of the Auryon device, including procedural performance and intermediate- and long-term clinical outcomes.
The pilot study will evaluate the safety and efficacy of Auryon in the treatment of de novo, restenotic, and in-stent restenosis lesions in infrainguinal arteries of patients with PAD. 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.
In October 2019, AngioDynamics acquired Eximo Medical, Ltd., the early commercial-stage medical device company that developed the system, previously known as the Eximo B-Laser. The commercial release of the Auryon atherectomy system in the United States will occur in the second half of AngioDynamics’ current fiscal year, advised the company.