Paclitaxel Coated Devices for Peripheral Artery Disease

Paclitaxel coated devices were first PMA approved by the FDA in 2012 to treat de novo and restenotic lesions in the superficial femoral arteries (SFA) and proximal popliteal arteries (PPA) in peripheral arterial disease (PAD) patients. Drug coated balloons (DCB) and drug eluting stents (DES) include a balloon catheter or stent, coated with an anti-proliferative pharmaceutical (paclitaxel) with or without other materials called excipients that help transfer the drug to the vessel wall. Currently, there are five paclitaxel-coated devices that are FDA-approved to treat de novo and restenotic lesions in the femoropopliteal arteries in PAD patients, as well as two that are FDA approved to treat dysfunctional native dialysis arteriovenous (AV) fistulas.

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