Technology Allows Ablation Device To Be Placed Outside Of Beating Heart

St. Paul, MN - St. Jude Medical, Inc. announced that the results of a multi-center clinical study of its High Intensity Focused Ultrasound (HIFU) cardiac tissue ablation device will be published in the September 2005 issue of the Journal of Thoracic and Cardiovascular Surgery (JTCVS).

Using a proprietary approach, the Epicor(TM) technology allows an ablation device to be placed on the outside of a beating heart and deliver high intensity focused ultrasound energy across the wall of the heart to create very precise and complete lines of cardiac tissue ablation. The Epicor(TM) Cardiac Ablation System includes the UltraCinch(TM) Ablation Device and the UltraWand(TM) Handheld Ablation Device.

From September 2002 through February 2004, 103 patients were prospectively enrolled in the multi-center study. The UltraCinch(TM) device was used to create a circumferential left atrial ablation with an average procedure time of 10 minutes. In some patients, additional linear lesions were created with the UltraWand(TM) handheld device using the same technology.

The study showed that at six-month follow-up, 85% of patients in the study group remained free from atrial fibrillation (80% in patients with permanent atrial fibrillation, 88% in patients who received an additional mitral line, and 100% in patients with paroxysmal atrial fibrillation). Only the duration and type of atrial fibrillation significantly increased the risk of recurrence.

"We are very pleased that this information is now available to the clinical community," commented Jane J. Song, President of St. Jude Medical's Atrial Fibrillation Division. "It provides valuable insight into HIFU technology and the Epicor(TM) Cardiac Ablation System's potential. We hope that by demonstrating the safety and reproducibility of this new technique, a more effective ablation procedure will be brought to an expanded patient population."

SOURCE: St. Jude Medical, Inc.