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AtriCure gets CE Mark for Isolator Transpolar clamps to treat cardiac arrhythmia
By E. Janene Geiss
Philadelphia, Sept. 11 - AtriCure, Inc. said Sunday that it has received CE Mark approval to market the Isolator Transpolar system for the treatment of cardiac arrhythmias, including atrial fibrillation.
The AtriCure clamps are the only bipolar radiofrequency clamps that are approved for this indication in the European Union, the West Chester, Ohio, medical device company said in a news release.
Ongoing, multi-center U.S. clinical trials are being conducted for expansion of the indication in the United States.
The system uses proprietary, automated, impedance-driven ablation algorithms to provide energy delivery tailored to the biophysics of the tissue for reliable transmural lesions without the risk of thermal spread.
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