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HeartLight™ Endoscopic Ablation System Now Available in the UK
Date:8/22/2011

reedom from AF.(2)  The technology is available at sites across Europe including Germany, Italy and the Czech Republic and will soon be the subject of a pivotal clinical trial in the United States.

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 HeartLight Endoscopic Ablation System for catheter ablation incorporates an endoscope to provide physicians with 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 HeartLight Endoscopic Ablation System received CE Mark in 2009 for the treatment of atrial fibrillation, and is commercially available at leading 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, USA.  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 HeartLight 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.

(1)  S Dukkipati. Persistent Pulmonary Vein Isolation Using the Visually-Guided Laser Balloon: Results of a Multicenter PV Remapping Study. Presented at Heart Rhythm 2011.

(2)  VY Reddy et al. Pulmonary Vein Isolation Using the Visually-Guided La
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SOURCE CardioFocus, Inc.
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1. CardioFocus HeartLight™ Endoscopic Ablation System Enables Treatment of Atrial Fibrillation: Live Case and Abstract Presented at EHRA EUROPACE 2011
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3. New Studies Support CardioFocus HeartLight™ Endoscopic Ablation Systems Notable Treatment Results for Paroxysmal Atrial Fibrillation
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