Biosense Webster obtains FDA clearance for new catheter featuring contact force-sensing technology

26 February 2014 (Last Updated February 26th, 2014 01:00)

Johnson & Johnson subsidiary Biosense Webster has received approval from the US Food and Drug Administration (FDA) for its ThermoCool SmartTouch force-sensing ablation catheter, designed for patients suffering from drug-resistant paroxysmal atrial fibrillation (Afib), sustained monomorphic ischemic ventricular tachycardia and Type I atrial flutter.

biosense webster

Johnson & Johnson subsidiary Biosense Webster has received approval from the US Food and Drug Administration (FDA) for its ThermoCool SmartTouch force-sensing ablation catheter, designed for patients suffering from drug-resistant paroxysmal atrial fibrillation (Afib), sustained monomorphic ischemic ventricular tachycardia and Type I atrial flutter.

The device is claimed to be the first therapeutic catheter approved in the US that gives direct and real-time measurement of contact force during catheter ablation procedures.

ThermoCool SmartTouch catheter uses radiofrequency energy (RF) to ablate interior portions of the heart muscle to prevent it from fluttering, or atrial fibrillation.

It is designed to enhance the physician's ability to more precisely control the amount of contact force applied to the heart wall when creating lesions during catheter ablation by providing direct, real-time quantitative feedback graphically displayed on the company's CARTO 3 system upon tissue contact.

The safety and effectiveness of the Thermocool Smarttouch catheter were evaluated in SMART-AF Trial, a prospective, multicentre study in patients with drug-resistant symptomatic paroxysmal atrial fibrillation.

"Data from the SMART-AF Trial demonstrated that consistent and stable application of contact force has a significant impact on patient outcomes."

Texas Cardiac Arrhythmia Institute at St David's Medical Center executive medical director and primary trial investigator Dr Andrea Natale said: "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."

According to the company, the one-year data from the trial showed a 74% overall success rate with the ThermoCool SmartTouch device.

Importantly, the success rate rose to 88% when physicians stayed within a targeted range at least 85% of the time.

Biosense Webster Worldwide president David Shepherd said: "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."


Image: Biosense Webster's Thermocool SmartTouch catheter. Photo: courtesy of Biosense Webster /Business Wire.