Biosense Webster, a worldwide developer in the treatment and diagnosis of heart arrhythmias, announced U.S. approval of the THERMOCOOL SMARTTOUCH SF Catheter.
The catheter, now available for sale in the U.S., is the only approved device pairing contact force technology with a porous tip designed to optimize efficiency. This optimizes efficiency by providing uniform cooling at half the flow rate of earlier generation irrigated catheters, easing the fluid management process.
Clinical data has demonstrated the safety of the device when used to treat drug refractory paroxysmal atrial fibrillation. The SMART-AF trial, a multicenter, prospective study of the earlier generation THERMOCOOL SMARTTOUCH technology, revealed no unanticipated adverse events and demonstrated a success rate of greater than 80%, with increased stability within the contact force range.
The more recent SMART-SF study, which tested the newest generation THERMOCOOL SMARTTOUCH SF Catheter, demonstrated excellent safety results as well. The study found an 18.7% reduction in overall procedure time and a 14.2% reduction in overall ablation time when compared to the SMART-AF study. It also demonstrated a 55.2% reduction in total fluoroscopy time, limiting radiation exposure to patients.
The catheter is seamlessly integrated with the CARTO 3 System, which combines contact force technology, 3D mapping and advanced navigation capabilities to provide active measurement of stable contact force and catheter tip location.
The THERMOCOOL SMARTTOUCH SF Catheter is available for commercial sale in the U.S. and Europe.