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Sex-Specific Analysis of Cardiovascular Function pp 107–121Cite as

Safety and Effectiveness of Medical Device Therapy

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Part of the book series: Advances in Experimental Medicine and Biology ((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.

Medical device therapy in cardiology. Art work by Piet Michiels, Leuven, Belgium

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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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  1. Division of Applied Regulatory Science, U.S. Food and Drug Administration, Silver Spring, MD, USA

    Robbert Zusterzeel

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Correspondence to Robbert Zusterzeel .

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Editors and Affiliations

  1. Department of Radiology and Nuclear Medicine, Amsterdam Cardiovascular Sciences, VU University Medical Center, Amsterdam, The Netherlands

    Peter L. M. Kerkhof

  2. Mayo Clinic, Rochester, Minnesota, USA

    Virginia M. Miller

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Zusterzeel, R. (2018). Safety and Effectiveness of Medical Device Therapy. In: Kerkhof, P., Miller, V. (eds) Sex-Specific Analysis of Cardiovascular Function. Advances in Experimental Medicine and Biology, vol 1065. Springer, Cham. https://doi.org/10.1007/978-3-319-77932-4_7

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