FDA Approves Biosense Webster's ThermoCool SmartTouch Ablation Catheter for Treatment of Atrial Fibrillation

February 25, 2014—Biosense Webster, Inc. (Diamond Bar, CA) announced today that it has received approval from the United States Food and Drug Administration (FDA) for its ThermoCool SmartTouch catheter. This therapeutic catheter enables direct and real-time measurement of contact force during catheter ablation procedures for patients experiencing drug-resistant paroxysmal atrial fibrillation, sustained monomorphic ischemic ventricular tachycardia, and type I atrial flutter.

According to Biosense Webster, providing doctors with contact force stability when applying radiofrequency energy 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, while too much contact may result in tissue injury, which may lead to complications.

The company stated that 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 that is 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.

The safety and effectiveness of the ThermoCool SmartTouch catheter were evaluated as part of a prospective, multicenter study called the SMART-AF trial in patients with drug-resistant symptomatic paroxysmal atrial fibrillation during standard electrophysiology mapping and radiofrequency procedures. Andrea Natale, MD, served as Primary Investigator of the SMART-AF trial. Dr. Natale is Executive Medical Director of the Texas Cardiac Arrhythmia Institute at St. David's Medical Center in Austin, Texas.

One-year results from the SMART-AF trial showed that patients experienced a 74% 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 1-year results demonstrating an 88% success rate when physicians stayed within a targeted range ≥ 85% 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, advised Biosense Webster.

In the company’s press release, Dr. Natale commented, “The ThermoCool SmartTouch catheter is an important new device that will benefit the electrophysiology community, as it will enable us to more precisely control the amount of contact force applied to the heart wall when creating lesions during catheter ablation.”

Dr. Natale continued, “Data from the SMART-AF trial demonstrated that consistent and stable application of contact force has a significant impact on patient outcomes. The use of contact force-sensing technology has emerged as a critical tool in delivering optimal outcomes in the treatment of patients with atrial fibrillation and represents a major advancement for the clinical community.”