The Auryon atherectomy system, previously known as the Eximo B-Laser, is a wavelength laser technology platform that AngioDynamics acquired in October 2019. The system is designed to treat de novo, re-stenotic and in-stent restenosis lesions in infrainguinal arteries of patients with PAD.
The Pathfinder I study is a prospective, non-randomized, single-arm, multicenter study set to evaluate the Auryon system’s performance during procedures and measure clinical outcomes. The study is slated to include 100 eligible PAD patients treated with the Auryon system, tracking them over a 36-month period following the initial procedure.
AngioDynamics said it expects the initial findings to contribute to a large pivotal phase registry that it hopes will include approximately 1,000 patients. Meanwhile, the Latham, N.Y.-based company plans to launch the Auryon system in the U.S. in the second half of fiscal 2020.
“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,” AngioDynamics VP for clinical affairs & healthcare economics Juan Carlos Serna said in a news release.