6-Month Results From the PATHFINDER Registry Evaluating the Safety and Efficacy of the Auryon Laser

Purpose: The purpose is to report the safety and efficacy of the Auryon Laser Atherectomy System (AngioDynamics) in a postmarket study treating infrainguinal lesions and occlusions.

Materials and Methods: In 104 patients (62.5% male; age 68.4 years ± 10.21 years; 53.8% with diabetes; 8.7% with chronic kidney disease; 46.1% with critical limb ischemia), 109 lesions were analyzed by an angiographic core lab. The average was length 13.54 cm (0.51–52.00 cm). There were 22.0% in-stent restenoses, 45.0% CTOs, 43.1% tibial lesions, and 37.6% moderate to severely calcified. Outcomes were reported up until 6 months after the procedure.

Results: All the lesions were crossed. The stenosis percentages were 87.2% ± 16.47%, 60.7% ± 21.12%, and 24.2% ± 15.43% at baseline, post laser, and post procedure, respectively. There were no procedural perforations, amputations, or deaths. Five (4.1%) bail-out stentings were required after adjunctive therapy (not laser related), and 2 (1.7%) distal embolization events occurred and resolved intraprocedurally without complications. At 30 days (n = 103), 1 (1.0%) amputation, 1 (1.0%) CD-TLR, and 1 (1.0%) TVR were reported without relation to Auryon. At 6 months (n = 89), the freedom from major adverse events was 94.4%, with 3 (3.4%) CD-TLRs, 1 (1.1%) amputation, and 1 (1.1%) TVR reported. Rutherford, ankle-brachial index, and WIQ improved at 6 months (n = 69,48,67) compared with baseline (3.69 ± 0.92 vs 1.68 ± 1.57; 0.73 ± 0.28 vs 0.86 ± 0.22; and 22.32 ± 22.50 vs 43.82 ± 27.99, respectively).

Conclusions: Initial postmarket data on real-world cases with Auryon in a variety of complex infrainguinal lesions demonstrates excellent safety and outcomes. Low CD-TLR rates with improved clinical presentation were consistent with prior data and stable out to 6 months.