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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.

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January 17, 2020

Study Shows More Than Half of United States Clinical Trials Fail to Comply With Law on Reporting Results

January 15, 2020

Vascular Medicine Consult Registry Launched for the SVS Vascular Quality Initiative