Therapy Cool Flex Ablation Catheter and Cardiac Ablation Generator get FDA approval

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The FDA has approved St Jude Medical’s Therapy Cool Flex Ablation Catheter and Cardiac Ablation Generator for the treatment of atrial flutter.

The Therapy Cool Flex Ablation Catheter is a steerable, deflectable, irrigated catheter that takes energy from an external source (the IBI1500T9-CP V1.7 Cardiac Ablation Generator) to a point in the right side of the heart. The ablation catheter has a laser-cut electrode tip which is different than the previous model of the device. The laser-cut pattern allows the tip to be flexible and provides a more uniform distribution of saline fluid to the ablation site.

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