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This article was originally published in The Gray Sheet

Executive Summary

Company reps meet with FDA June 4 to discuss a trial design for the Artic Circler atrial fibrillation ablation catheter; firm hopes to begin an IDE trial later this year. The meeting came two days after FDA's Circulatory System Devices Panel unanimously voted against recommending approval of Cardima's Revelation Tx AF ablation catheter, largely due to difficulties in obtaining AF burden data from patients (1"The Gray Sheet" June 2, 2003, p. 3)...
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