Overview of the 2011 food and drug administration's circulatory system devices panel of the medical devices advisory committee meeting on the Zilver PTX drug-eluting peripheral stent. [Review]
Available in print through MWHC library: 2002 - present
Zilver PTX (Cook Medical, Bloomington, IN) is a self-expanding nitinol drug-eluting stent with a polymer-free paclitaxel coating on its outer surface. The stent aims to provide improved treatment for patients with symptomatic peripheral arterial disease in the above-the-knee femoropopliteal arteries. On October 13, 2011, the Food and Drug Administration's (FDA) Circulatory System Devices Panel reviewed the Zilver PTX premarket approval application. This summary aims to describe the discussions and recommendations made during the meeting. Based on the Panel's recommendations, it is anticipated that the device will be approved by the FDA. Copyright 2012. Published by Elsevier Inc.
English
1878-0938
*Cardiovascular Agents/ad [Administration & Dosage] *Coated Materials, Biocompatible *Device Approval *Drug-Eluting Stents *Endovascular Procedures/is [Instrumentation] *Femoral Artery *Paclitaxel/ad [Administration & Dosage] *Peripheral Arterial Disease/th [Therapy] *Popliteal Artery *United States Food and Drug Administration Advisory Committees Alloys Constriction, Pathologic Endovascular Procedures/ae [Adverse Effects] Evidence-Based Medicine Humans Prosthesis Design Randomized Controlled Trials as Topic Registries Treatment Outcome United States