11:06 AM EDT, 07/28/2025 (MT Newswires) -- AngioDynamics ( ANGO ) said Monday it has enrolled a first patient in a clinical study evaluating its Auryon atherectomy system in patients with critical limb ischemia below the knee.

The study will evaluate the safety and effectiveness of the Auryon atherectomy system together with standard balloon angioplasty in treating infrapopliteal lesions in patients with critical limb ischemia, AngioDynamics ( ANGO ) said.

The trial will enroll up to 224 patients across 30 sites and a 12-month primary endpoint will be assessed using a hierarchical win-ratio approach - evaluating freedom from major amputation, freedom from clinically-driven target lesion revascularization, and primary patency, the company said.

AngioDynamics ( ANGO ) also said it plans to run a companion registry alongside the trial, enrolling up to 1,500 additional patients who are ineligible for the RCT but are treated with the Auryon system above or below the knee.

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