St. Jude Launches Irrigated Ablation Catheter for Atrial Flutter


May 14, 2007

May 15, 2007 — St. Jude Medical Inc. announced last week an expanded European CE Mark approval to include the Therapy Cool Path irrigated ablation catheter with bi-directional steering for use in ablation procedures to treat abnormal heart rhythms.

This catheter is the first open-irrigated ablation catheter to provide bi-directional steering, a feature designed to help physicians maneuver the catheter in difficult areas of the heart and perform complex ablations more efficiently.

“The main advantage of the bi-directional catheter is its ease of use in reaching difficult anatomical locations,” said Carlo Pappone, M.D., Ph.D., F.A.C.C., director of the Arrhythmology Department at San Raffaele University Hospital in Milan. “Because the catheter requires less manipulation and provides for greater simplicity of navigation, my procedural time was improved by about 20 percent.”

St. Jude Medical also announced FDA approval and release of the uni-directional Therapy Cool Path open-irrigated ablation catheter for use in patients with type 1 atrial flutter. With atrial flutter, the heart’s upper chambers beat steadily faster than normal, often resulting in a feeling of lightheadedness.

An open-irrigated catheter distributes saline fluid into heart tissue through ports in the tip of the catheter to enhance cooling during ablation procedures. Cooling the tip of the catheter is designed to reduce the risk of undesirable tissue damage at the procedure site. Studies have shown that open-irrigated catheters safely and effectively create deeper and larger lesions while using less energy than standard therapy catheters.

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