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Overview of the 2012 Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory Committee meeting on the Edwards SAPIEN.

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Presentation on theme: "Overview of the 2012 Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory Committee meeting on the Edwards SAPIEN."— Presentation transcript:

1 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  Israel M. Barbash, MD, Danny Dvir, MD, Ron Waksman, MD  American Heart Journal  Volume 165, Issue 5, Pages (May 2013) DOI: /j.ahj Copyright © 2013 Mosby, Inc. Terms and Conditions

2 Figure Complication rates of high-risk patients included in the PARTNER trial randomized to TAVR and the nonrandomized, single-arm registry of high-risk patients undergoing TAVR included in the CAP. Complication rates were much lower in the CAP than in the RCT: Stroke (3.1% vs 4.4%), major vascular complication (4.2% vs 11.1%), and major bleeding (4.6% vs 10.8%). American Heart Journal  , DOI: ( /j.ahj ) Copyright © 2013 Mosby, Inc. Terms and Conditions


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