AGA’s Amplatzer for headaches
This article was originally published in The Gray Sheet
Executive Summary
AGA Medical begins a 120-patient, multi-center, randomized trial of its Amplatzer patent foramen ovale occluder device to reduce the number and severity of migraines. Patient enrollment in the PFO closure Reduction In Migraine with Aura (PRIMA) trial commenced May 3 to examine the connections between certain types of migraines and heart defects affecting 20% of adults, the firm says. PRIMA differs from previous PFO migraine trials, such as NMT Medical's MIST I, in that the endpoint is 50% reduction of migraines in 50% of patients, AGA says. MIST I failed to meet its primary endpoint of complete migraine cessation (1"The Gray Sheet" April 17, 2006, p. 9)...
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