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Safety and Effectiveness of Medical Device Therapy

  • Robbert Zusterzeel
Chapter
Part of the Advances in Experimental Medicine and Biology book series (AEMB, volume 1065)

Abstract

When enough females and males are enrolled in clinical trials, much more relevant information is available on potential sex differences in device safety and effectiveness. Unfortunately, females have largely been underrepresented in clinical studies of cardiac medical device therapies for heart failure. In this chapter, sex differences in heart failure characteristics and cardiac electrophysiology and their influence on the safety, effectiveness, and application of implantable cardioverter defibrillators (ICDs), subcutaneous ICDs (S-ICDs), and cardiac resynchronization therapy (CRT) will be discussed. In this way, the research community will hopefully become more appreciative of the potential differences in device effects between females and males.

Keywords

Medical devices Sex differences Mortality Demographic subgroups Defibrillator Pacemaker Female 

Notes

Acknowledgments

The author gratefully acknowledges the insightful comments of Dr. Marjorie Jenkins and Dr. Pamela Scott (FDA) as well as those from the editors and peer reviewers.

Disclaimer

The mention of commercial products, their sources, or their use in connection with material reported herein is not to be construed as either an actual or implied endorsement of such products by the Department of Health and Human Services. The opinions expressed are those of the author and do not necessarily reflect the views or policies of the US Food and Drug Administration.

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Copyright information

© Springer International Publishing AG, part of Springer Nature 2018

Authors and Affiliations

  1. 1.Division of Applied Regulatory ScienceU.S. Food and Drug AdministrationSilver SpringUSA

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