St. Jude CEO Confident In PFO Device Despite Competitor’s Failure
This article was originally published in The Gray Sheet
Executive SummarySt. Jude Medical remains confident in its development-stage patent foramen ovale closure device for prevention of strokes or migraines, despite the well publicized failure of competing PFO device developer NMT Medical, CEO Daniel Starks said.
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FDA's Circulatory System Devices Panel said that St. Jude's Amplatzer PFO closure device has benefits that outweigh risks to prevent recurrent stroke in a select group of patients on an 11-5 vote, despite having missed its primary endpoint in the pivotal RESPECT trial.
St. Jude won a May panel date for its Amplatzer patent foreman ovale occluder PMA, seeking approval to prevent recurrent stroke. It's been a challenging path to this point after the firm's pivotal RESPECT trial did not meet its primary endpoint in 2012.
There was some expectation leading up to TCT that the two trials could provide a definitive ruling on whether the PFO closure procedure had a future or not. But actual outcomes sparked a range of interpretations.