St. Jude Medical has received European CE Mark approval and U.S. Food and Drug Administration (FDA) clearance for the Epicor™ LP Cardiac Ablation System, a second generation technology that uses HIFU (high intensity focused ultrasound) to surgically ablate cardiac tissue to disrupt abnormal electrical impulses in the heart.

A patient has already undergone treatment with the Epicor LP System, a 73-year-old male who had suffered from coronary artery disease and atrial fibrillation (AF) for over three years. Malcom Dalrymple-Hay, FRCS Ph.D. FECTS, a cardiac surgeon at Derriford Hospital in Plymouth, United Kingdom performed the operation. The patient had a normal heart rhythm upon completion of the ablation procedure.

"An increasing volume of published literature is demonstrating the benefits of treating pre-existing AF in patients who are undergoing valvular or coronary artery bypass surgery," said Dr. Dalrymple-Hay. "The Epicor LP System provides me with a technology that is flexible enough to treat AF patients during either standard open chest procedures or minimally invasive surgical procedures."
AF is the most common abnormal heart rhythm condition, affecting millions of patients worldwide. Abnormal electrical activity disrupts the upper chambers of the heart, which cannot effectively pump blood.

A traditional surgical approach requires that patients be placed on a heart-lung bypass machine with their hearts stopped while a cardiac surgeon cuts patterns in the atrial tissues to create lesions. The lesions disrupt the abnormal electrical impulses that cause AF.

In surgical ablation performed with a HIFU energy source, energy is focused from outside a beating heart, which creates precise and complete lines of cardiac tissue ablation to block chaotic electrical impulses. The outside HIFU energy is directed at the heart inward and risk of unintended peripheral damage is minimized.

The Epicor LP system has features designed to facilitate easier device introduction and placement around and on patients' hearts and is equally suited for use in both closed-chest procedures performed through a single incision, and in open-chest procedures.

The 2007 results confirmed the findings of an earlier European multi-center trial published in the September 2005 Journal of Thoracic and Cardiovascular Surgery, which reported an 85 percent freedom-from-AF rate at six months post-procedure.

Adapted from a press release from St. Jude.

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