Biosense Webster has announced U.S. approval of the Thermocool Smarttouch SF catheter. The catheter, now available for sale in the United States, pairs 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 percent, with increased stability within the contact force range.1*
The more recent SMART-SF study, which tested the newest generation Thermocool Smarttouch SF catheter, demonstrated excellent safety results as well.2 The study found an 18.7 percent reduction in overall procedure time and a 14.2 percent reduction in overall ablation time when compared to the SMART-AF study. It also demonstrated a 55.2 percent reduction in total fluoroscopy time, limiting radiation exposure to patients.3
The catheter is seamlessly integrated with the CARTO 3 System, which combines contact force technology, 3-D 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 United States and Europe.
*Success is defined as freedom from any atrial arrhythmia (atrial fibrillation, atrial flutter, atrial tachycardia) 12 months post procedure when operator remained in the preset contact force range. Further sub-analysis showed that when the contact force was within investigator-selected range ≥ 85% of time, success was increased by 21 percent to 88 percent (≥ 85 percent: n = 32; < 85 percent: n = 73).
1 Natale A, et al. SMART-AF trial. J Am Coll Cardiol. 2014; 64(7): 647-656. Biosense Webster, Inc. Final Clinical Report, October 2014.
1 THERMOCOOL SMARTTOUCH® Catheter IFU (M-5276-693/694)
2 Prospective Safety Assessment of the THERMOCOOL SMARTTOUCH® SF Family of Contact Force Sensing Catheters for the Radiofrequency Ablation Treatment of Drug Refractory Symptomatic PAF (Smart-SF). Biosense Webster, Inc. Final Clinical Report, January 2016
3 Compared to SMART-AF study.