FDA approves Thermocool SF catheter

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The US Food and Drug Administration (FDA) has approved the Thermocool SF irrigated ablation catheter (Biosense Webster) in the United States for treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation when used with Carto systems and type 1 atrial flutter for patients 18 years and older.

The ThermocoolSF NAV catheter combines Biosense Webster’s latest irrigated ablation technology with the accurate visualisation of the Carto3 3D mapping and ablation system. The catheter was launched in Europe in October 2010.


The Thermocool SF catheter allows for uniform cooling of the entire catheter tip, and efficient heat dissipation when ablating. This feature provides more effective cooling and allows half the volume load to the patient, when compared to the traditional Thermocool catheter.