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The Medical Device Manufacturer’s Perspective: W.L. Gore and Associates, Inc.

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Patent Foramen Ovale

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Abstract

W.L. Gore and Associates, Inc. (Gore) provides its perspective as a medical device manufacturer on the contributions industry has made in helping to further the PFO-stroke field. Over the last decade, Gore has contributed to the field’s advancement by investing in the development of technological solutions for PFO closure, such as with the GORE® HELEX® Septal Occluder and the GORE® Septal Occluder. Additionally, the design and sponsorship of clinical study infrastructures to support the investigation of the proposed treatment option represent a significant contribution of human and monetary resources. The decision to initiate or continue investment in this arena relies on an ongoing assessment of the associated PFO-stroke market opportunity and the availability of a viable pathway to a PFO-stroke indication within the United States.

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Abbreviations

ASD:

Atrial Septal Defect

FDA:

Food and Drug Administration

Gore:

W.L. Gore & Associates Inc.

PFO:

Patent Foramen Ovale

PMA:

Premarket Approval

RoPE:

Risk of Paradoxical Embolism

TIA:

Transient Ischemic Attack

US:

United States

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Author information

Authors and Affiliations

  1. Structural Heart Business, W.L. Gore and Associates, Inc., 4250 W. Kiltie Lane, Flagstaff, AZ, 86001, USA

    Jake A. Goble PhD

Authors
  1. Jake A. Goble PhD
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Corresponding author

Correspondence to Jake A. Goble PhD .

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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Goble, J.A. (2015). The Medical Device Manufacturer’s Perspective: W.L. Gore and Associates, Inc.. 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_26

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  • DOI: https://doi.org/10.1007/978-1-4471-4987-3_26

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  • Publisher Name: Springer, London

  • Print ISBN: 978-1-4471-4986-6

  • Online ISBN: 978-1-4471-4987-3

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