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CardioFocus Inc. Release: International Leaders in Electrophysiology Discuss Improving Atrial Fibrillation Treatment Using Novel Endoscopically Guided Laser Ablation Catheter


4/28/2011 7:54:46 AM

MARLBOROUGH, Mass., April 28, 2011 /PRNewswire/ -- CardioFocus, Inc., developer of the Endoscopic Ablation System for the transcatheter treatment of Atrial Fibrillation (AF), convened international leaders in electrophysiology to discuss the advantages of direct optical visualization to guide catheter ablation for the treatment of paroxysmal AF. The event followed the first day of the German Society for Cardiology Annual Meeting in Mannheim, Germany.

The symposium, "Does Optical Visualization Help to Improve the Durability of Pulmonary Vein Isolation?," was co-chaired by renowned electrophysiologists Prof. Karl-Heinz Kuck, MD, of Krankenhaus St. Georg, Hamburg, Germany, and Petr Neuzil, MD, of Na Homolce Hospital, Prague, Czech Republic. The clinical experience of three leading centers was presented examining the use of the CardioFocus Endoscopic Ablation System, a unique compliant balloon ablation catheter able to deliver, visually guided laser energy to achieve durable pulmonary vein isolation (PVI) after only a single clinical procedure.

"It is broad industry consensus that permanent control of paroxysmal atrial fibrillation requires that the pulmonary veins must be permanently isolated. However, conventional point-to-point ablation done without optical visualization offers only limited efficacy and requires multiple procedures," remarked Stephen Sagon, President and CEO of CardioFocus, Inc. "We are pleased that our Endoscopic Ablation System technology is being recognized by international leaders in the field as a solution that meets significant clinical needs. The HeartLight catheter from CardioFocus offers electrophysiologists unique endocardial visualization to provide better outcomes from a single procedure."

The German Symposium highlighted promising independent results from St. Georg (Hamburg) presented by Andreas Metzner, MD, and from the Institute for Clinical & Experimental Medicine (Prague) presented by Prof. Josef Kautzner, MD, PhD. This research included long-term results validated by remapping. Using the CardioFocus Endoscopic Ablation System, the rate of acute isolation of the pulmonary veins has been reported at 99% in several published, peer reviewed articles. Chronic pulmonary vein isolation has also been reported to be near 90% when assessed at three months.

Also featured were results from "Pulmonary Vein Isolation Using the Visually-Guided Laser Balloon: The First 200-Patient Multicenter Clinical Experience in Europe and US," previewed by Boris Schmidt, MD of Cardioangiologisches Centrum Bethanien of Frankfurt, Germany. Full results from this study will be presented at Heart Rhythm 2011, the Heart Rhythm Society's 32nd Annual Scientific Sessions, Friday, May 6, 2011.

About CardioFocus, Inc.

CardioFocus, Inc. is a medical device manufacturer dedicated to advancing ablation treatment for cardiac disorders such as atrial fibrillation (AF). Its novel Endoscopic Ablation System incorporates a catheter containing both a micro-endoscope and light energy fibers to give physicians the capacity to see within the heart, and for the first time, visually direct the application of laser energy to achieve durable pulmonary vein isolation.

The CardioFocus Endoscopic Ablation System received CE Mark in 2009 for the treatment of atrial fibrillation, and is commercially available at key institutions throughout Europe. The device is investigational in the U.S., with a pivotal study expected to commence in 2011. CardioFocus is headquartered in Marlborough, MA. For more information on the company and its technology, please visit www.CardioFocus.com.

The scientific information discussed in this news release is preliminary and investigative. The CardioFocus Endoscopic Ablation System is not approved by the U.S. Food and Drug Administration (FDA), and no conclusions can or should be drawn regarding the safety or effectiveness of the system. Only FDA can determine whether the product candidates are safe and effective for the use(s) being investigated. Healthcare professionals should refer to/rely upon FDA-approved labeling for the products, and not the information discussed in this news release.

Company Contact:

Media Contact:

Anjie Roldan

Lisa Cook/ Jason Rando

Vice President Finance

(646) 536-7012/7025

(508) 658-7237

lcook@theruthgroup.com

aroldan@cardiofocus.com

jrando@theruthgroup.com



SOURCE CardioFocus, Inc.


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