CardioFocus Receives CE Mark for Atrial Fibrillation Ablation Catheter


July 8, 2009

July 8, 2009 – CardioFocus Inc. said yesterday it received a CE mark in Europe for its Endoscopic Ablation System (EAS) to treat patients with atrial fibrillation.

The EAS is the latest generation, percutaneous catheter system that has been used clinically to treat patients with atrial fibrillation. The device incorporates both a microendoscope and light energy fibers 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.

Professional medical societies have endorsed the use of catheter ablation therapy for atrial fibrillation when antiarrhythmic drugs are ineffective, which can occur more than half the time.

“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, M.D., director of electrophysiology laboratories at the Mount Sinai Medical Center in New York City.

The EAS was the subject of several presentations at the recent Heart Rhythm Society meeting in Boston, highlighting excellent clinical results, simplified ease of use, reduced X-ray exposure and shortened procedure times. 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. Since clinical results were reported at the 2009 Boston AF Symposium, physician interest in visually guided catheter ablation has accelerated dramatically. As reported by several top centers, current catheter therapies are effective in barely 50 percent of patients receiving a single treatment.

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