St. Jude Shoots For 2016 With PFO Closure Device For Stroke
This article was originally published in The Gray Sheet
Executive Summary
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.
You may also be interested in...
St. Jude Hopes Its PFO Occluder Gets RESPECT At May FDA Panel
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.
VADs Set To Enter Big Leagues With St. Jude's Plan To Acquire Thoratec
St. Jude Medical says it will pay $3.4 billion to own ventricular-assist device leader Thoratec, pointing to significant synergies in the heart failure and interventional cardiology markets. The deal would thrust VADs into a diversified cardiology firm for the first time, and it includes a "go-shop" period that leaves an opening for other big device firms to enter competing bids.
RESPECT And PC Trial Results In, But Still No Real ‘Closure’ On PFO
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.