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.