FDA Clears Biosense Webster Direct Contact Force Catheter Ablation Therapy


February 28, 2014
Biosense Webster Thermocool Smarttouch Catheter Atrial Fibrillation Ablation EP

February 28, 2014 — The U.S. Food and Drug Administration (FDA) approved Biosense Webster Inc.’s Thermocool Smarttouch Catheter. The therapeutic catheter 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 (RF) against the heart wall during catheter ablation has been shown to improve outcomes; 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 provides direct, real-time quantitative feedback graphically displayed on the company’s Carto 3 System upon tissue contact. 

Thermocool Smarttouch Catheter was evaluated as part of a prospective, multicenter study called the SMART-AF Trial in patients with drug-resistant symptomatic paroxysmal atrial fibrillation. One-year results from the trial showed that patients experienced a 74 percent overall success rate after treatment with the Thermocool Smarttouch Catheter. Data from the trial showed higher success rates the longer physicians stayed within a targeted contact force range, with one-year results demonstrating an 88 percent success rate when physicians stayed within a targeted range greater than or equal to 85 percent of the time. The trial demonstrated for the first time that it is the consistent and stable application of contact force on the heart wall that positively impacts the efficacy of the procedure in this patient population.

For more information: www.biosensewebster.com