Positive Long-Term Data Plug Doubts Over PFO-Closure Stroke Benefits
Data from the REDUCE, CLOSE, and RESPECT trials, published in the New England Journal of Medicine, showed that closing a patent foramen ovale with a percutaneous closure device can reduce the risk of ischemic stroke in patients who have already had a cryptogenic stroke. Observers believe these trials showed a benefit of PFO closure in this population after previous trials failed to show a benefit largely because they did a better job of only selecting patients most likely to benefit.
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WL Gore's Cardioform Septal Occluder is now the second device to gain PMA approval to close the patent foramen ovale heart defect, to help prevent repeat ischemic stroke, according to FDA's website.
New clinical data with the potential to change clinical practice will be presented at the 2018 American College of Cardiology Scientific Session and Expo in Orlando, Fla., Mar. 10-12. Among the planned late-breaking trials and featured research presentations is a study of Zoll's LifeVest wearable external cardioverter-defibrillator following a heart attack; new results from a trial of Abbott's Amplatzer PFO-closure device, and long-term data on Abbott's HeartMate 3 ventricular assist device.
REDUCE is the first trial of patent foramen ovale closure device to show statistically significant reduction in stroke recurrence in its primary intent-to-treat analysis. The results, presented at the European Stroke Organisation Conference in Prague, will support Gore's application for Cardioform to the US FDA by the end of the year.