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CardioFocus Endoscopic Ablation System Earns CE Mark to Treat Atrial Fibrillation; US Clinical Investigation Underway
Date:8/19/2007

MARLBOROUGH, Mass., Aug. 1 /PRNewswire/ -- CardioFocus, Inc. announced today that it has been awarded CE Mark approval for its proprietary Endoscopic Ablation System. This novel transvenous device combines real-time, full color, endoscopic visualization and guidance with the delivery of therapeutic light energy to perform pulmonary vein isolation for the treatment of atrial fibrillation.

The Endoscopic Ablation System has been designed to treat the most common heart rhythm disturbance called atrial fibrillation, a disease affecting more than 5 million people in Europe and in the United States in addition to millions more worldwide. "We're very gratified to have achieved this level of confirmation for the work we have accomplished and the potential for aiding patients afflicted with atrial fibrillation worldwide," said Stephen Sagon the Company's President and CEO. "The CE Mark confirms our satisfaction of the EU medical device directives and assures patients and clinicians that our European clinical results and our manufacturing quality systems are of high caliber."

The CardioFocus Endoscopic Ablation System has also received US IDE approval for clinical investigation in a randomized, multi-center study, currently underway and enrolling patients at over a dozen leading medical centers across the country. Patients with symptomatic paroxysmal atrial fibrillation may learn about inclusion and exclusion criteria for the ENABLE trial, including information about participating centers at: http://www.clinicaltrials.gov/ct/show/NCT00477230?order=1

Study co-principal investigator Andrea Natale, MD of the Cleveland Clinic Foundation commented, "I am very satisfied with our ability to access anatomical targets and to achieve electrical isolation. The real-time view using the Endoscopic Ablation System provides a truly unique opportunity to tailor ablation therapy in a
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SOURCE CardioFocus, Inc.

Copyright©2007 PR Newswire.

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