FDA approves catheter for AF ablation

The FDA approved a therapeutic catheter that can be used to measure contact force during cardiac ablation.

The THERMOCOOL SMARTTOUCH catheter is applied in ablation procedures using radiofrequency energy as a treatment for atrial fibrillation (AF). Manufacturer Biosense Webster claims the device provides direct, real-time quantitative feedback displayed graphically on a mapping and navigation system to assist electrophysiologists during a catheter ablation.

The pivotal SMART-AF Investigational Device Exemption clinical trial assessed the safety and effectiveness of the device. The results, presented in 2013 at the Heart Rhythm Society's Scientific Session, showed the trial met its safety and effectiveness endpoints, with 72 percent of patients remaining free from recurrence of AF at 12-month follow-up.