Safety and Feasibility of Intravascular Lithotripsy for Treatment of Common Femoral Artery Stenoses

Purpose: To evaluate the safety and feasibility of treating calcified, stenotic common femoral arteries (CFAs) using the Peripheral Intravascular Lithotripsy (IVL) System. Methods: An analysis was performed of 21 patients (mean age 71.9±10.1 years; 16 men) across 3 sites with calcified CFA stenoses treated with the Peripheral IVL System. The outcomes of interest were the ability to deliver IVL to the target lesion, the increase in acute gain, the reduction in diameter stenosis, the rate of provisional stenting, and angiographically defined complications. Results: Access to the target lesion and delivery of treatment by the IVL catheter were successful in all 21 patients. Post treatment mean diameter stenosis was 21.3%, representing an acute mean lumen gain of 3.1±1.3 mm (range 0.7–5.2). Vascular complications were minimal, with only 5 type B (non-flowing-limiting) dissections reported. The profunda femoris artery was patent in all patients following IVL, and none of the subjects experienced a perforation, distal embolization, thrombus, no reflow, or abrupt closure. Conclusion: These early results demonstrate that calcified, stenotic CFA lesions can be safely and successfully treated using the Peripheral IVL System