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.
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.
Interventional Cardiology, Washington Hospital Center, Washington, DC 20010, USA.
Danny
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Rebecca
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Torguson
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Waksman
D026683:Advisory Committees; D000497:Alloys; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D020099:Coated Materials, Biocompatible; D003251:Constriction, Pathologic; D018795:Device Approval; D054855:Drug-Eluting Stents; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation*; D019317:Evidence-Based Medicine; D005263:Femoral Artery; D006801:Humans; D017239:Paclitaxel / Q000008:administration & dosage*; D058729:Peripheral Arterial Disease / Q000628:therapy*; D011150:Popliteal Artery; D011474:Prosthesis Design; D016032:Randomized Controlled Trials as Topic; D012042:Registries; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration
D000497:Alloys; D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible; C013616:nitinol; D017239:Paclitaxel