The BEnefit of LONGitudinal Micro-Incisions Prior to Paclitaxel-Coated Balloon Angioplasty (BELONG Study) in Patients With Lower Extremity Arterial Disease: Clinical Outcomes at 12 Months.

This article focuses on a prospective single-arm study evaluating the 12-month clinical outcomes of vessel preparation using the FLEX Vessel Prep™ System (FLEX VP) prior to drug-coated balloon percutaneous transluminal angioplasty (DCB-PTA) in patients with symptomatic lower extremity peripheral artery disease involving the superficial femoral or popliteal arteries. The FLEX VP device creates 12 longitudinal micro-incisions in calcified and complex lesions to improve vessel compliance and drug delivery, aiming to reduce flow-limiting dissections and the need for stenting. Among 41 patients treated, 92.7% had no flow-limiting dissections post-procedure, with stenting required in 39% primarily for residual stenosis; freedom from clinically driven target lesion revascularization at 12 months was 97.5%, and no major amputations occurred. The study suggests that vessel preparation with longitudinal micro-incisions may enhance long-term patency and clinical outcomes in heavily calcified femoral and popliteal artery lesions, though it notes the absence of a control group and recommends further controlled studies.