Biosense Webster has concluded patient enrollment in the SMART-AF Investigational Device Exemption (IDE) study, evaluating the safety and effectiveness of its Thermocool SmartTouch Catheter.
The SMART-AF study enrolled 173 patients at leading centers across the US to demonstrate the ability of Thermocool SmartTouch Catheter in treating symptomatic, drug-refractory, paroxysmal atrial fibrillation.
The Thermocool SmartTouch Catheter relies on RF catheter technology, which measures the contact force and direction that the catheter exerts on the heart tissue in real time.
The catheter during cardiac ablation procedures allows the measurement of catheter tip contact force and direction inside the heart.
The Thermocool SmartTouch Catheter is the new addition of the Navistar Thermocool Catheter family, which is FDA approved for the treatment of symptomatic, drug-refractory, paroxysmal atrial fibrillation.