Two Laser Balloon 'Live Cases' Shed New Light on Direct Visualization and PV Ablation

MARLBOROUGH, Mass., Jan. 24, 2011 /PRNewswire/ -- CardioFocus announced that two "live cases" using its Endoscopic Ablation System were recently conducted. The first live case was a satellite transmission performed at Centro Cardiologico Monzino in Milan, Italy; broadcast to the 16th Annual Boston Symposium on Atrial Fibrillation in Boston, MA. Several pioneers in the treatment of atrial fibrillation served as moderators for this exciting educational presentation, providing perspective on ablation procedures designed to isolate pulmonary veins.

The second live case was performed at St. Georg Hospital, in Hamburg, Germany, by Prof. Karl-Heinz Kuck. Both cases demonstrate the continued interest of leading catheter ablation experts to gain a real time view of the anatomy they are treating to enable durable PV isolation.

Stephen Sagon, CEO of CardioFocus said, "These back-to-back live cases provide CardioFocus with a unique opportunity to be seen by clinicians from around the world. Now that we have CE Mark approval for the latest version of our equipment, we have received requests from multiple, well-respected international arrhythmia centers. We plan to continue our highly disciplined launch of the Endoscopic Ablation System at key European sites in 2011."

The acute isolation rate of pulmonary veins has been reported by CardioFocus clinical investigators at over 99% in peer reviewed articles. While nearly all of the pulmonary veins were isolated during the procedure, 78% of veins were isolated on the very first attempt. Chronic PV isolation was reported to approach 90% when assessed at 3 months. According to Burke Barrett, CardioFocus Vice President of Clinical and Regulatory Affairs, "We expect more scientific studies and further presentations on our Endoscopic Ablation System technology throughout the year, including the  company's US IDE pivotal study in the first half of 2011."

Two years after the initiation of clinical research, approximately 250 patients have been treated under multiple research protocols at 16 different medical centers world-wide. More than 150 patients were treated in the EU and almost 100 patients were enrolled in a US feasibility clinical trial.

The information in this news release related to our product is preliminary and investigative. The CardioFocus System is not approved by the FDA, and no conclusions can or should be drawn regarding its safety or effectiveness.

SOURCE CardioFocus