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]

MedStar author(s):
Citation: Cardiovascular Revascularization Medicine. 13(5):281-5, 2012 Sep-Oct.PMID: 22898055Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Journal Article | ReviewSubject headings: *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 StatesLocal holdings: Available in print through MWHC library: 2002 - presentISSN:
  • 1878-0938
Name of journal: Cardiovascular revascularization medicine : including molecular interventionsAbstract: 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.All authors: Dvir D, Torguson R, Waksman RDigital Object Identifier: Date added to catalog: 2013-09-17
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Item type Current library Collection Call number Status Date due Barcode
Journal Article MedStar Authors Catalog Article Available 22898055

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.

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