News | July 08, 2009

CardioFocus Receives CE Mark for Atrial Fibrillation Ablation Catheter

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.

For more information: www.cardiofocus.com

Related Content

Reflow Medical's Wingman Crossing Catheter Receives FDA Clearance for Coronary Indication
News | Catheters| October 02, 2017
October 2, 2017 — Reflow Medical Inc. announced that the company has received 510(k) clearance from the U.S.
Roxwood Medical Announces Agreement With Abbott for U.S. Product Distribution
News | Catheters| August 09, 2017
Roxwood Medical Inc. recently announced it has entered into an exclusive agreement with Abbott for distribution of...
Teleflex, FDA 510k clearance, TrapLiner Catheter, U.S. launch
Technology | Catheters| March 02, 2017
Teleflex Inc. has announced 510(k) clearance by the U.S. Food and Drug Administration (FDA) and U.S. commercial launch...
Merit Medical Systems, SwiftNINJA Steerable Microcatheter, FDA 510(k) clearance
Technology | Catheters| November 09, 2016
November 9, 2016 — Merit Medical Systems Inc.
VentureMed Group, Flex Scoring Catheter, FDA approval, peripheral arterial disease, PAD, endovascular treatment
Technology | Catheters| July 13, 2016
July 13, 2016 — VentureMed Group Ltd., specializing in devices for the endovascular treatment of...
Roxwood Medical, MicroCross Catheter, full U.S. launch

Image courtesy of Roxwood Medical

Technology | Catheters| January 07, 2016
Roxwood Medical Inc. reported that more than 500 patients have been successfully treated as part of the initial limited...
Overlay Init