St. Jude receives CE Mark, FDA nod for HIFU cardiac ablation system

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St. Jude Medical has received European CE Mark approval and FDA clearance for the Epicor LP cardiac ablation system, a second generation technology that uses high-intensity focused ultrasound (HIFU) for cardiac ablation surgical procedures.

In surgical ablation performed with a HIFU energy source, the company said that the energy is focused from outside a beating heart. The treatment has been designed to create precise and complete lines of cardiac tissue ablation to block chaotic electrical impulses. HIFU energy is directed from outside the heart inward, minimizing the risk of unintended peripheral damage, according to the St. Paul, Minn.-based company.