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Gore PFO closure trial

This article was originally published in The Gray Sheet

Executive Summary

W.L. Gore announces FDA go-ahead May 5 for a 700-patient clinical trial of its Helex septal occluder for patent foramen ovale closure to prevent recurrence of cryptogenic stroke or transient ischemic attack. The REDUCE trial will randomize patients to receive either the Helex with medical management or medical management alone. Gore is recruiting up to 50 trial sites in the U.S. and Nordic countries and will begin enrolling patients this summer. The firm says its primary endpoint of freedom from recurrent ischemic stroke, imaging confirmed transient ischemic attack, or death from stroke at two-year follow-up is unique. Other PFO closure devices in trials for stroke include NMT Medical's Starflex and AGA Medical's Amplatzer (1"The Gray Sheet" Dec. 9, 2007, p. 9)
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