St. Jude gets European OK for cardiac ablation system

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

Receiving the CE Mark from the European Union means that St. Jude is free to sell its EnSite Contact Technology platform, which measures the amount of electricity that’s being used to create lesions that interrupt electrical signals causing irregular heart rhythms, in Europe, according to a statement from St. Jude.

The system hasn’t been cleared for U.S. sales.

The system is designed to be used with irrigated catheters, thin, flexible tubes that deliver electricity to heart tissue. Using an irrigated catheter helps reduce the risks associated with the heat created in ablation procedures, such as blood coagulation and charring, according to the statement.

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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.

Brandon Glenn

Brandon Glenn MedCity News

Brandon Glenn is the Ohio bureau chief for MedCity News.

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