UPDATE 1-Hansen gets conditional FDA nod for catheter trial

Wed May 12, 2010 9:28am EDT

* Says trial to study safety, efficacy of catheter system

* Shares up 12 pct pre-market

May 12 (Reuters) - Hansen Medical Inc (HNSN.O) said it received conditional approval from the U.S. health regulator for a clinical trial of its catheter system for the treatment of atrial fibrillation, or irregular heartbeat.

Hansen got conditional investigational device exemption from the U.S. Food and Drug Administration to conduct a trial, which would study the safety and efficacy of the company's Sensei X robotic catheter system and the Artisan control catheter.

Hansen's robotic catheter system helps to place mapping catheters within the heart easily, during complex cardiac arrhythmia procedures.

Safety is defined as the absence of early onset of all major adverse events, and efficacy as freedom from atrial fibrillation through one year, Hansen said.

Up to 14 sites worldwide will enroll about 300 subjects for the trial.

Shares of the company were trading up about 7 percent at $2.67 Wednesday before the bell. They closed at $2.50 Tuesday on Nasdaq. (Reporting by Anuradha Ramanathan in Bangalore; Editing by Unnikrishnan Nair) ((anuradha.ramanathan@thomsonreuters.com; within U.S. +1 646 223 8780; outside U.S. +91 80 4135 5800: Reuters Messaging: anuradha.ramanathan.reuters.com@reuters.net))

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