FDA Raises Doubts Over Insufficient AtriCure Trial

Law360, New York (October 24, 2011, 9:51 PM EDT) -- The U.S. Food and Drug Administration asked an advisory panel Monday to review whether medical device company AtriCure Inc.'s alternative irregular heart rate treatment for atrial fibrillation meets safety and effectiveness goals after a small clinical trial showed insufficient results.

In a memorandum prepared for an Oct. 26 meeting of the Circulatory System Devices Panel, the FDA expressed concerns about whether the AtriCure Synergy Ablation System — already approved and commercially available for the ablation of cardiac tissue — can be used to treat atrial fibrillation...
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