biosense-1Biosense Webster Inc. has received approval from the U.S. Food and Drug Administration for its ThermoCool SmartTouch catheter. It is the first therapeutic catheter approved in the U.S. that enables direct and real-time measurement of contact force during catheter ablation procedures for patients suffering from drug-resistant paroxysmal atrial fibrillation (Afib), sustained monomorphic ischemic ventricular tachycardia and Type I atrial flutter.

Providing doctors with contact force stability when applying radiofrequency energy against the heart wall during catheter ablation has been shown to improve outcomes as inconsistent tissue contact may result in incomplete lesion formation that could result in the need for additional treatment, and too much contact may result in tissue injury, which may lead to complications. The ThermoCool SmartTouch catheter enhances a physician’s ability to achieve stable and consistent application of contact force by providing direct, real-time quantitative feedback graphically displayed on the company’s Carto 3 system upon tissue contact. Without this technology, catheter tip-to-tissue contact has to be estimated through other indirect measures such as electrogram parameters and impedance but they have been shown to be poor predictors of contact force.

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