AngioDynamics has 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 arterial 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,” says Juan Carlos Serna, AngioDynamics Vice president for Clinical Affairs and Healthcare Economics.
AngioDynamics’ PATHFINDER I registry is a prospective, non-randomised, single arm, multicentre 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.
The commercial release of the AURYON atherectomy system in the USA will occur in the second half of the fiscal year.