CardioFocus, Inc. announced that it has received a CE Mark approval for Endoscopic Ablation System (EAS). The EAS is used to treat patients with atrial fibrillation. This novel device incorporates both a light energy fibers and micro-endoscope to give physicians the capacity to actually see within the heart, and for the first time, visually direct the application of energy through a catheter.

We are grateful for the thorough review and the rapid response we received from our notified body, said Burke Barrett, CardioFocus VP of Clinical and Regulatory Affairs.

The EAS represents a new era for catheter ablation of this complex arrhythmia. The CardioFocus device provides the electrophysiologist with a direct view of the cardiac anatomy that simply has not been available using other catheters. I believe that seeing the true orientation of the anatomy in full color and in real time, combined with the ability to safely and reliably deliver energy to the right target, increases the likelihood of delivering effective therapy, said Vivek Y. Reddy, MD, Director of Electrophysiology Laboratories at The Mount Sinai Medical Center in New York City.

Several presentations highlighted excellent clinical results, simplified ease of use, reduced x-ray exposure and shortened procedure times of EAS at the recent Heart Rhythm Society meeting in Boston. The CardioFocus device was also featured on the scientific program at the EuroPace meeting in Berlin in June, and will be prominent on the program at the Europe AF meeting in London in September. Physician interest in visually guided catheter ablation has been accelerating dramatically after the clinical results of EAS reported at the 2009 Boston AF Symposium.

CE Marking for our product highlights the great progress our company has made; our entire group has been dedicated to achieving this milestone. This facilitates more ambitious international research and European commercialization of our device. Cardiac electrophysiology is a focused area of medicine where a small company can make a big impact with the right product. Our interactions with well known specialists worldwide have provided enormous encouragement, commented Stephen W. Sagon, CardioFocus President and CEO.