FDA Approves New Ablation Catheter to Treat Atrial Fibrillation

The US Food and Drug Administration (FDA) has approved a new ablation catheter for use in patients with medication-resistant paroxysmal atrial fibrillation (AF), type 1 atrial flutter, and sustained monomorphic ischemic ventricular tachycardia.

The Thermocool Smarttouch is the first therapeutic catheter approved to enable direct and real-time measurement of contact force during ablation procedures, which allows stable application of contact force, according to the device’s manufacturer, Biosense Webster.

Data from the SMART-AF trial presented at the Heart Rhythm Society’s meeting in May 2013 showed the catheter had a 74% overall success rate in drug-resistant AF patients. The device’s success rates were even higher when physicians stayed within a targeted contact force range for long time periods, as 1-year results demonstrated 88% success rates when physicians were within contact force range ≥85% of the time.

The catheter provides contact force stability while physicians apply radiofrequency energy against the heart wall during catheter ablation. Without the technology, catheter tip-to-tissue contact must be estimated through indirect methods that are poor predictors of contact force, the manufacturer noted.

The SMART-AF trial deemed the catheter safe in AF patients, with an adverse event rate of 9.9% at 7 days.