CardioFocus receives CE mark for AF ablation catheter

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CardioFocus has announced that it has received CE mark allowing the company to commence European marketing of the 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. This novel device incorporates both a micro-endoscope and light energy fibres 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.


“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, director of Electrophysiology Laboratories at The Mount Sinai Medical Center in New York, US.


The EAS was the subject of several presentations at the recent Heart Rhythm Society meeting in May, Boston, US, 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, Germany, 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 been accelerating dramatically. As reported by several top centres, current catheter therapies are effective in barely 50% of patients receiving a single treatment.