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NMT Medical To Redesign PFO Trial After Problems With MIST I

This article was originally published in The Gray Sheet

Executive Summary

NMT Medical will redesign its U.S. pivotal trial for the STARflex patent foramen ovale closure device to treat migraine headaches after its UK trial missed its primary endpoint

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NMT Medical Hopes To Avoid Another Headache In Modified Migraine Trial

NMT Medical will move forward with its planned PFO closure migraine study under a new trial design cleared recently by FDA, the firm announced Aug. 31

NMT Medical Hopes To Avoid Another Headache In Modified Migraine Trial

NMT Medical will move forward with its planned PFO closure migraine study under a new trial design cleared recently by FDA, the firm announced Aug. 31

AGA Medical’s PREMIUM trial

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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