Study Establishes Link Between PFO And Cryptogenic Stroke In Older Patients
This article was originally published in The Gray Sheet
Executive Summary
A new study shows a correlation between patent foramen ovale (PFO) and cryptogenic strokes in older patients
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AGA Medical Pursues Stroke, Migraine Indications And $200 Mil. IPO
AGA Medical hopes to complete a pivotal U.S. trial by year-end assessing its Amplatzer PFO Occluder for prevention of recurrent cryptogenic strokes, the company says in a June 20 prospectus for a planned initial public offering worth up to $200 million
AGA Medical Pursues Stroke, Migraine Indications And $200 Mil. IPO
AGA Medical hopes to complete a pivotal U.S. trial by year-end assessing its Amplatzer PFO Occluder for prevention of recurrent cryptogenic strokes, the company says in a June 20 prospectus for a planned initial public offering worth up to $200 million
Gore PFO closure trial
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)