Biosense Webster enrols first patient in the SMART-AF IDE study


Biosense Webster announced the enrolment of the first patient in the SMART-AF investigational device exemption 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 and FDA approved NaviStar ThermoCool catheter family, in the treatment of symptomatic, drug-refractory, paroxysmal atrial fibrillation. SMART-AF expects to enrol up to 164 patients in leading centres 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, via the novel Carto 3 Smarttouch module, to create a fully integrated solution combining contact force, 3D mapping and navigation capabilities.

Andrea Natale, executive medical director, Texas Cardiovascular Arrhythmia Institute at St. David’s Medical Center, performed the first case, he said, “The Thermocool Smarttouch catheter is a breakthrough technology in the field of electrophysiology. It provides me with new contact force information during atrial fibrillation ablations. I look forward to further evaluating this technology in the SMART-AF study,” he concluded.

Biosense Webster’s NaviStar ThermoCool irrigated ablation catheter remains the only FDA approved radiofrequency navigation catheter for the treatment of symptomatic drug refractory atrial fibrillation on the market today.