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.
Keywords
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- 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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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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