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January 14, 2013

Biotech Firm: Product Trial Advances

A Marlborough medical device manufacturer said a trial of its catheter ablation system designed to treat patients with irregular heartbeats is about half enrolled.

CardioFocus Inc. is seeking approval for the device from the U.S. Food and Drug Administration (FDA). The study, initiated last year, is on track to complete enrollment in 2013 for use of the product, HeartLight, the company said in a statement. The firm would then prepare data to submit to the FDA.

CardioFocus said the system is clinically available in Europe and Australia.

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