NMTI: When a company’s product requires an invasive procedure (PFO closure) to prevent something that has a low likelihood of occurring (stroke/TIA), it needs stellar clinical data to have any chance for commercial uptake. That obviously wasn’t the case in this trial, nor was it the case in a similar trial that tested PFO closure to prevent migraine attacks.
PFO-closure procedures will continue to be performed—but only for patients who have symptoms directly attributable to the PFO, which is a tiny market.
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