FDA warns St. Jude Medical on improper cardiac catheter promotion

May 18, 2010 by MedCity News

The Food & Drug Administration sends a warning letter to St. Jude Medical Inc. citing the device maker for promoting a cardiac ablation catheter system for an unapproved use.

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By Brandon Glenn

The Food & Drug Administration sent a warning letter to St. Jude Medical Inc. (NYSE:STJ) that cites the device maker for improperly promoting a cardiac ablation catheter system.

St. Jude promoted its Epicor cardiac ablation catheter system on its website for use in treating atrial fibrillation, an irregular heartbeat that can result in stroke. However, the system has only received FDA approval to be used in ablation, or destruction, of diseased heart tissue during surgery.

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