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AGA Medical’s PREMIUM trial

This article was originally published in The Gray Sheet

Executive Summary

Firm initiates enrollment of its PREMIUM randomized trial to evaluate migraine reduction using its Amplatzer patent foramen ovale (PFO) occluder device, announced July 20. AGA expects to enroll 400 patients at up to 35 medical centers in the U.S. NMT similarly intends to focus on headache reduction following disappointing results from its U.K.-based MIST trial that showed the firm's STARflex PFO closure device to be no more effective than placebo in eliminating migraines entirely (1"The Gray Sheet" April 17, 2006, p. 9)...

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