July 7, 2009
Marlborough Med. Device Firm Receives Euro Approval
By Matthew L. Brown
Marlborough-based CardioFocus Inc.'s endoscopic ablation system (EAS) has received the CE mark, which allows the company to begin marketing the system in Europe.
The EAS uses a catheter system to allow physicians to actually see within the heart and direct the application of energy through the catheter. The company said the system is intended for use in patients for whom anti-arrhythmic drugs are ineffective.
The CE mark is a consumer safety designation valid in the European Union.
The EAS has not been approved by the U.S. Food and Drug Administration.
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