Biosense Webster has obtained an approval from the US Food and Drug Administration (FDA) for its Thermocool Smarttouch catheter that enables direct and real-time measurement of contact force during catheter ablation procedures for patients suffering from drug-resistant paroxysmal atrial fibrillation, sustained monomorphic ischemic ventricular tachycardia and Type I atrial flutter.
The company claims that the new catheter enhances a clinician'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.
Safety and effectiveness of the Thermocool Smarttouch catheter has been assessed in SMART-AF trial. One-year results from the study demonstrated that patients experienced a 74% overall success rate after treatment with the Thermocool Smarttouch catheter.
The SMART-AF 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.
Biosense Webster worldwide president David Shepherd noted the company is pleased to be able to introduce this important advancement to help clinicians enhance the quality of care they deliver for the thousands of US atrial fibrillation patients in need of alternative treatments to drug therapy.
"The burden of atrial fibrillation on quality of life, morbidity and mortality is well-documented and we are committed to developing life-enhancing therapies to continue addressing unmet needs in this space," Shepherd added.