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Passeo-18 Lux is a **drug-coated balloon (DCB)** catheter designed for percutaneous transluminal angioplasty of narrowed or restenotic segments in peripheral arteries, especially in the femoropopliteal and infrapopliteal arteries, as well as for the treatment of obstructive lesions of native or synthetic arteriovenous (AV) fistulae. The device consists of a low-profile balloon catheter homogeneously coated with **paclitaxel** (3 µg/mm²) using butyryl-tri-n-hexyl citrate (BTHC) as an excipient. This design aims to maximize drug transfer to the vessel wall—minimizing drug loss during deployment—and inhibit neointimal hyperplasia, thereby reducing restenosis and the need for reintervention. Passeo-18 Lux has demonstrated both safety and efficacy in multiple randomized clinical trials and registries for peripheral arterial disease and is supported by robust clinical data. The product is CE-marked and widely used in Europe and other jurisdictions[1][3][7][8].
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