Advisors Provide Lukewarm Endorsement Of St. Jude's PFO Occluder For Stroke
This article was originally published in The Gray Sheet
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.
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The US Market for interventional cardiology products, which includes diagnostic and therapeutic products, is anticipated to expand from an estimated $3.3 billion in 2015 to roughly $3.6 billion in total product sales by the year 2020. One bright spot in this otherwise lackluster market is the interventional diagnostic products segment, which is projected to grow at CAGR of 4.7% and reach almost $1 billion by 2020, according to a report by Medtech Insight.
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.