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Stellarex is a paclitaxel-coated angioplasty balloon catheter system used for percutaneous transluminal angioplasty of de-novo or restenotic lesions in the superficial femoral, popliteal, and infrapopliteal arteries in patients with peripheral artery disease, including those with complex, calcified lesions.[2][3][7][11][12] The device consists of an over-the-wire dual-lumen balloon catheter whose outer balloon surface is coated with the cytotoxic antiproliferative agent paclitaxel at a low dose density of 2 µg/mm², formulated in a hybrid amorphous–crystalline form and combined with a polyethylene glycol (PEG) excipient (EnduraCoat technology) to optimize coating stability, vascular wall drug transfer, and sustained tissue residency during the critical 28‑day restenosis window.[1][2][4][7][9][12] By locally delivering paclitaxel to the arterial wall during balloon inflation, Stellarex inhibits smooth muscle cell proliferation and neointimal hyperplasia to improve vessel patency and reduce restenosis compared with standard angioplasty, and it has been evaluated in the ILLUMENATE clinical program and approved in the United States and other regions for femoropopliteal disease, including treatment of in-stent restenosis.[2][3][5][7][9][11][12]
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