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The Novel PFO Specific Closure Devices: Why Did They Fail?

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Patent Foramen Ovale

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Abstract

The potential markets of PFO closure including migraine, stroke, and sleep apnea induced the medical device industry to investigate PFO specific device alternatives to ASD indicated devices. The medical device community further recognized the unique PFO anatomy consisting of two overlapping walls as an opportunity for a minimally invasive solution. Numerous PFO specific devices were developed with either a minimal footprint or nothing left behind. Despite promising clinical results, the failure of both the randomized migraine and stroke trials led to an unclear pathway for US approval and commercialization. The investors of each of these devices eventually elected to no longer fund the development and regulatory approval of these devices. Should the RESPECT or PREMIUM Trials lead to a US indication for PFO closure we may see resurgent interest in the less invasive solutions to PFO closure.

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Author information

Authors and Affiliations

  1. Division of Cardiology, Intermountain Heart Institute, Salt Lake City, UT, USA

    Brian Whisenant MD

Authors
  1. Brian Whisenant MD
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Correspondence to Brian Whisenant MD .

Editor information

Editors and Affiliations

  1. Children's Hospital of Georgia, Augusta, Georgia, USA

    Zahid Amin

  2. UCLA, Los Angeles, California, USA

    Jonathan M. Tobis

  3. CardioVascular Center, Frankfurt, Germany

    Horst Sievert

  4. University of Colorado Denver Anschutz Medical Campus, Aurora, Colorado, USA

    John D. Carroll

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© 2015 Springer-Verlag London

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Whisenant, B. (2015). The Novel PFO Specific Closure Devices: Why Did They Fail?. In: Amin, Z., Tobis, J., Sievert, H., Carroll, J. (eds) Patent Foramen Ovale. Springer, London. https://doi.org/10.1007/978-1-4471-4987-3_18

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  • DOI: https://doi.org/10.1007/978-1-4471-4987-3_18

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  • Publisher Name: Springer, London

  • Print ISBN: 978-1-4471-4986-6

  • Online ISBN: 978-1-4471-4987-3

  • eBook Packages: MedicineMedicine (R0)

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