St. Jude Hopes Its PFO Occluder Gets RESPECT At May FDA Panel
This article was originally published in The Gray Sheet
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.
You may also be interested in...
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.
Slam-dunk data supporting patent foramen ovale closure to prevent stroke has been elusive, but St. Jude now says discussions with FDA suggest that its device could be approved in 2016 following a panel meeting.
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.