The neurology community has amassed a great deal of evidence that a certain type of heart defect known as a PFO is associated with an increased risk of stroke. This finding has prompted companies with transcatheter devices developed for a niche pediatric congenital defect market to migrate to adult stroke prevention. In the new field, the risk isn't so much technical--a history of device use in the pediatric market has obviated alot of this risk--as clinical. In stroke prevention, clinical trials not only have to prove a negative, which is always difficult, but will also have to confirm the role of PFOs in stroke, as yet scientifically unproven, at the same time as they validate devices.
by Mary Stuart
A 37-year-old business traveler was arriving at his home airport after a seven-hour transatlantic flight. He stood up, strained to...
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