Abstract

ABSTRACT Introduction The Zilver PTX stent was the first self-expanding drug-coated stent approved by the United States Food and Drug Administration (US FDA) for use in the superficial femoral artery (SFA) above the knee. The main objective of this article is to review the design, safety, and efficacy of the Zilver PTX stent which was engineered to outperform bare metal stents (BMS) in this challenging environment. Areas covered An evaluation of the Zilver PTX peripheral paclitaxel-coated stent design and a review of the current preclinical and clinical evidence regarding the use of this stent. Expert opinion Stent implantation for the treatment of peripheral arterial disease (PAD) in the SFA was initially seen as a salvage option; however, stenting is now routinely offered as initial therapy for patients suffering from claudication and critical limb ischemia. The Zilver PTX stent has established efficacy and safety profiles for paclitaxel in the SFA; however, the development of biocompatible polymers capable of extending the elution time of anti-proliferative agents may lead to more effective stent platforms.

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