Drug Administration Circulatory System Research Articles

Overview of the 2012 Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory Committee meeting on the Edwards SAPIEN transcatheter heart valve for high-risk aortic stenosis patients

The Edwards SAPIEN transcatheter heart valve (THV) is approved for aortic stenosis patients considered inoperable because of high surgical risk. Based on the high-risk arm of the PARTNER trial, the Food and Drug Administration's Circulatory System Devices Panel reviewed an additional indication for use in high-risk, operable patients. Although several concerns were raised regarding safety, trial misconduct, and several subgroup analyses, most panel members agreed that the Edwards SAPIEN THV (Edwards Lifesciences LLC, Irvine, CA), when used in high-risk patients, is noninferior to surgical aortic valve replacement. The panel voted 11 to 0 (with 1 abstention) that the benefits of the Edwards SAPIEN THV do outweigh the risks for use in the indicated patient population. This summary aims to describe the discussions and recommendations made during the meeting. Based on the panel recommendation, the device was approved by the Food and Drug Administration.

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.

Summary of the Food and Drug Administration's Circulatory System Devices Advisory Panel Meeting

The Food and Drug Administration (FDA) has been monitoring the use of drug-eluting stents (DES) since they were approved for use in the United States. The Cypher sirolimus-eluting stent (SES) was approved in 2003 and the Taxus Express 2 paclitaxel-eluting stent (PES) in 2004. Recent presentations at scientific meetings have suggested a small but significant increase in the rates of (1) death or myocardial infarction (MI) (possibly due to stent thrombosis) and (2) noncardiac mortality in DES-treated patients compared to patients treated with bare metal stents (BMS). The FDA therefore convened a public meeting of the Circulatory System Devices Advisory Panel on December 7 and 8, 2006, in an effort to fully characterize the risks, timing, and incidence of DES thrombosis. Cordis Corporation, Boston Scientific, and other US device companies presented on the incidence of stent thrombosis and overall safety of DES. The FDA asked the panel to address specific questions. 1. When used in accordance with their labeled indications, are DES associated with an increased rate of stent thrombosis, death, or myocardial infarction compared to bare metal stents? Most centers report DES utilization rates of N80%, with at least 60% of that being off-label. By definition, bofflabelQ use refers to practices for which a device or drug is not recommended by regulators, yet the FDA had asked the panel to make recommendations about such use.