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Gore's PFO Closers REDUCE Recurrent Ischemic Strokes By 77% In Trial

 
• By Reed Miller

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.

Results of the REDUCE trial show WL Gore & Associates Inc.'s septal occluders significantly reduce the chances of recurrent ischemic stroke in patients with a patent foramen ovale – commonly known as hole in the heart – and a history of stroke compared to antiplatelet therapy alone.

REDUCE compared the efficacy and safety of PFO-closure using Gore's Cardioform septal occluder or the earlier generation Helex septal occluder plus antiplatelet drugs to antiplatelet drug therapy alone in 664...

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