CardioFocus Receives CE Mark For Atrial Fibrillation Ablation Catheter

Main Category: Cardiovascular / Cardiology
Also Included In: Heart Disease;  Medical Devices / Diagnostics;  Regulatory Affairs / Drug Approvals
Article Date: 08 Jul 2009 - 2:00 PDT

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CardioFocus, Inc. announced that it has received a 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 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. "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.

Atrial Fibrillation is a common cardiac arrhythmia affecting several million people in Europe and over 2.5 million more in the United States. Symptoms can range from weakness and dizziness to more profound morbidity including stroke. Researchers believe that the considerable incidence and prevalence of the disease are increasing due to aging populations worldwide. Professional medical societies have endorsed the use of catheter ablation therapy when anti-arrhythmic drugs are ineffective, which can occur more than half the time.

"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.

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 been accelerating dramatically. As reported by several top centers, current catheter therapies are effective in barely 50% of patients receiving a single treatment.

"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.

Source: CardioFocus, Inc