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Atrial Flutter

FDA approves EPT-1000 XP cardiac ablation system

Published in Biotech Business Week, September 22nd, 2003

Boston Scientific Corporation (BSX) announced that it has received premarket approval (PMA) from the U.S. Food and Drug Administration (FDA) for its EPT-1000 XP Cardiac Ablation System for the treatment of atrial flutter.

It has been estimated that there are more than 200,000 new patients diagnosed with atrial flutter each year in the United States. The abnormal electrical signal causing atrial flutter occurs in the right atrium, in a circular pattern. Successful ablation procedures occur when a linear lesion is created across the tricuspid isthmus. This lesion interrupts the abnormal electrical circuit in a bi-directional manner, allowing the heart to return to normal...

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