St. Jude lands FDA win for 2 next-gen cardiac ablation catheters | Regulatory Roundup

February 6, 2012 by MassDevice staff

St. Jude Medical wins pre-market approval for its Therapy Cool Path Duo and Safire Blu Duo cardiac ablation catheters, plus a new ablation generator.

St. Jude's ablation systems

St. Jude Medical Inc. (NYSE:STJ) won pre-market approval for 2 next-generation cardiac ablation systems this month, the Therapy Cool Path Duo and Safire Blu Duo catheters.

Both ablation systems use radiofrequency energy to freeze small areas of faulty cardiac tissue in patients with typical trial flutter, a type of arrhythmia in which patients experience abnormal heart rhythms or an abnormally fast heartbeat in the upper chambers of the heart.

The Irvine, Calif.-based company also won approval for a new model cardiac ablation generator, according to FDA documents (PDF).

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Both catheter systems have already been approved in Europe and in several Asia Pacific markets, St. Jude spokeswoman Amy Jo Meyer told MassDevice in an email.