St. Jude wins European approval for cardiac ablation system

June 17, 2010 by MedCity News

St. Jude Medical Inc. lands European regulatory approval for a cardiac ablation system used to correct arrhythmias.

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By Brandon Glenn

St. Jude Medical Inc. (NYSE:STJ) received European regulatory approval for a cardiac ablation system used in procedures to destroy diseased tissue in patients with abnormal heart rhythms.

Receiving the CE Mark means that St. Jude may beginning marketing and selling its EnSite Contact Technology platform in the Eurpean Union. The system has not been cleared for U.S. sales.

The system measures the amount of electricity that's being used to create lesions that interrupt the electrical signals that cause irregular heart rhythms, according to a statement from St. Jude. The device platform is designed to be used with irrigated catheters, which are thin, flexible tubes that deliver electricity to heart tissues. Using an irrigated catheter helps reduce risks associated with the heat created in ablation procedures, such as blood coagulation and charring, according to the statement.

Separately, St. Jude said it has enrolled the first of what could be 700 patients in a clinical trial of a heart-pressure monitoring system. The system measures left atrial pressure, which is considered the "gold standard" for assessing the status of heart-failure patients.