Biosense Webster, a specialist in the diagnosis and treatment of cardiac arrhythmias, has completed patient enrollment in its SMART-AF Investigational Device Exemption study, designed to evaluate Thermocool SmartTouch Catheter as a treatment for atrial fibrillation (AF).
The SMART-AF study has enrolled 173 patients across the US to demonstrate the safety and effectiveness of the Thermocool SmartTouch Catheter for treating symptomatic, drug-refractory, paroxysmal AF. The item is based on radiofrequency (RF) catheter technology, which measures the contact force and direction that the catheter exerts on the heart tissue in real time.
The Thermocool SmartTouch Catheter is the latest addition to the Navistar Thermocool Catheter stable of products, which is approved in US for the treatment of symptomatic, drug-refractory, paroxysmal atrial fibrillation.
Loyola University Cardiology director David Wilber said the device has been performing well during the SMART-AF cases. ''The ability to measure contact force and direction in real time, as I map and ablate, is enabling me to maneuver the catheter confidently, and is becoming a key measure in my procedures,'' he said. ''Additionally, the integration of this technology into the Carto 3 Mapping and Navigation System facilitates incorporation into my workflow."
Biosense Webster worldwide president Shlomi Nachman added that the follow-up data from the SMART-AF trial will be used for the submission to Food and Drug Administration (FDA).
While performing cardiac ablation procedures, the Thermocool SmartTouch Catheter allows the measurement of catheter tip contact force and direction inside the heart. The information is graphically displayed on the Carto 3 mapping and navigation system.
The company has also received FDA clearance to launch its Thermocool SF irrigated ablation catheter in US.
According to the company, the Thermocool SF catheter's design, as well as with porous tip and Surround Flow technology, enables uniform cooling of the entire catheter tip, in addition to efficient heat dissipation when ablating.
Biosense Webster, a Johnson & Johnson company, is an provider of advanced diagnostic, therapeutic, and mapping tools against cardiac arrhythmias.