July 14th, 2011 – Biosense Webster, Inc., a worldwide leader in the diagnosis and treatment of cardiac arrhythmias, announced the enrollment of the first patient in their latest groundbreaking clinical trial, the SMART-AF Investigational Device Exemption (IDE) study, and the treatment of the first patient with the new ThermoCool® SmartTouch™ Contact Force Sensing Catheter and Software Module in the United States.The SMART-AF study is designed to demonstrate the safety and effectiveness of ThermoCool® SmartTouch™, the latest addition to the market-leading and FDA approved NaviStar® ThermoCool® Catheter family, in the treatment of symptomatic, drug-refractory, paroxysmal atrial fibrillation. SMART-AF expects to enroll up to 164 patients in leading centers across the United States.
The ThermoCool® SmartTouch™ Catheter is one of the most advanced catheters developed by Biosense Webster to date. During cardiac ablation procedures, the ThermoCool® SmartTouch™ Catheter enables the measurement of catheter tip contact force and direction inside the heart. This information is graphically displayed on the CARTO® 3 Mapping and Navigation System, the most advanced 3D Mapping System available on the market today, via the novel Carto® 3 Smarttouch™ Module, to create a fully integrated solution combining contact force and 3D mapping and navigation capabilities... Johnson and Johnson's Press Release -
