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Date of download: 6/24/2016 Copyright © The American College of Cardiology. All rights reserved. From: Overview of the 2011 Food and Drug Administration.

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Presentation on theme: "Date of download: 6/24/2016 Copyright © The American College of Cardiology. All rights reserved. From: Overview of the 2011 Food and Drug Administration."— Presentation transcript:

1 Date of download: 6/24/2016 Copyright © The American College of Cardiology. All rights reserved. From: Overview of the 2011 Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting on the CardioMEMS Champion Heart Failure Monitoring System J Am Coll Cardiol. 2013;61(15):1571-1576. doi:10.1016/j.jacc.2012.08.1035 Cumulative HF Hospital Stays Cumulative heart failure (HF) hospital stays of the treatment and control groups throughout the duration of the study. RRR = relative risk reduction. Figure Legend:

2 Date of download: 6/24/2016 Copyright © The American College of Cardiology. All rights reserved. From: Overview of the 2011 Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting on the CardioMEMS Champion Heart Failure Monitoring System J Am Coll Cardiol. 2013;61(15):1571-1576. doi:10.1016/j.jacc.2012.08.1035 Freedom From HF Hospital Stay or Death Freedom from heart failure (HF) hospital stay or death of the treatment and control groups throughout the duration of the study. HR = hazard ratio. Figure Legend:

3 Date of download: 6/24/2016 Copyright © The American College of Cardiology. All rights reserved. From: Overview of the 2011 Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting on the CardioMEMS Champion Heart Failure Monitoring System J Am Coll Cardiol. 2013;61(15):1571-1576. doi:10.1016/j.jacc.2012.08.1035 Number of Pressure Readings, Reviews, and Recommendation Emails Total number of pulmonary artery (PA) pressure readings taken, the total number of reviews performed by investigator log-ins, and the number of recommendation emails sent to investigators in 6 months for the treatment group patients. Figure Legend:

4 Date of download: 6/24/2016 Copyright © The American College of Cardiology. All rights reserved. From: Overview of the 2011 Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting on the CardioMEMS Champion Heart Failure Monitoring System J Am Coll Cardiol. 2013;61(15):1571-1576. doi:10.1016/j.jacc.2012.08.1035 HRs of Sex Subgroups for HF Hospital Stays Hazard ratios (HRs) according to sex subgroups for HF hospital stays throughout the duration of the study. CI = confidence interval. Figure Legend:

5 Date of download: 6/24/2016 Copyright © The American College of Cardiology. All rights reserved. From: Overview of the 2011 Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting on the CardioMEMS Champion Heart Failure Monitoring System J Am Coll Cardiol. 2013;61(15):1571-1576. doi:10.1016/j.jacc.2012.08.1035 HF Hospital Stays by EF This figure shows the heart failure (HF) hospital stay rates according to baseline preserved and reduced left ventricular ejection fraction (EF) at 6 months. RRR = relative risk reduction. Figure Legend:


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