A Medical Device Daily

St. Jude Medical (St. Paul, Minnesota) reported that it received CE-mark approval and FDA clearance for the Epicor LP cardiac ablation system, a second-generation technology that uses high-intensity focused ultrasound (HIFU) to surgically ablate cardiac tissue to disrupt abnormal electrical impulses in the heart.

In surgical ablation performed with a HIFU energy source, energy is focused from outside a beating heart. This treatment has been designed to create precise and complete lines of cardiac tissue ablation to block chaotic electrical impulses. The patient does not need to be placed on a heart-lung bypass machine, nor is the heart stopped.

St. Jude said that because HIFU energy is directed from outside the heart inward (instead of from the inside out as is sometimes the case in ablations performed with other energy sources), the risk of unintended peripheral damage is minimized.

In contrast, the traditional surgical approach requires that patients be placed on a heart-lung bypass machine with their hearts stopped while a cardiac surgeon cuts maze-like patterns in the atrial tissues and then sews the incisions to encourage the formation of lesions.

The Epicor LP system has a lower profile (smaller relative to the first-generation technology), as well as other features designed to facilitate easier device introduction and placement around and on patients' hearts. The system is suited for use in both open-chest procedures and closed-chest procedures performed through a single incision.