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St. Jude Medical announces U.S. FDA clearance of software for cardiac mapping, navigation

Published in Medical Letter on the CDC and FDA, June 14th, 2006

St. Jude Medical, Inc. (STJ) announced U.S. Food and Drug Administration (FDA) clearance of the EnSite System Version 6 software, which provides improved clinical capabilities for cardiac mapping and navigation during electrophysiology (EP) procedures.

EnSite System Version 6 is designed to provide highly detailed, three-dimensional (3-D) cardiac models at the time of an EP procedure. The 3-D model is created in small sections that join together automatically creating a cardiac model that more accurately shows the openings, ridges and curves in the heart. The models are used to collect information about the heart's electrical activity and assist in diagnosing and...

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