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Drug intelligence / Profile preview
Paclitaxel is a small molecule microtubule-stabilizing agent that serves as the anti-proliferative component of the Legflow drug-coated balloon (DCB), developed by Cardionovum GmbH for the treatment of peripheral artery disease (PAD). The Legflow device utilizes the proprietary SAFEPax coating technology, which consists of a lipophilic matrix of paclitaxel and an ammonium salt excipient. This coating is designed to facilitate the rapid and efficient transfer of paclitaxel into the arterial wall during balloon inflation. Once in the tissue, paclitaxel binds to the beta-subunit of tubulin, promoting microtubule assembly and preventing disassembly. This action arrests the cell cycle in the G2/M phase, effectively inhibiting the proliferation and migration of vascular smooth muscle cells, which are the primary drivers of neointimal hyperplasia and restenosis following balloon angioplasty. The MAGNIFICENT trial demonstrated the efficacy and safety of the Legflow DCB compared to plain old balloon angioplasty (POBA) in treating atherosclerotic lesions in the superficial femoral and popliteal arteries.
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