Abstract
The FDA’s objectives with regard to approval of medical devices have been previously described as to ensure that medical devices are safe and effective for marketing and that they are made available to the health care environment expeditiously. Prevention of recurrent cryptogenic stroke in patients with recognized patent foramen ovale (PFO) by transcatheter PFO closure with previously FDA approved atrial septal defect occluders stands out as a particularly difficult and thorny problem both for clinicians and the FDA. Continued discussion with the FDA would confirm the desire to prove superiority of device closure of PFO over medical therapy for stroke prevention in a well controlled randomized trial in order to allow PMA with stroke prevention as the indication for use.
Note: The views and opinions presented are those of the author and do not necessarily reflect those of the US Food and Drug Administration, the US Department of Health and Human Services, or the Public Health Service.
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Hagler, D.J. (2015). From FDAs Point of View: What Is Needed to Move PFO Closure for Stroke Prevention Forward?. 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_25
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DOI: https://doi.org/10.1007/978-1-4471-4987-3_25
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