Devi Nair, Martin Martinek, B Judson Colley, Sri Sundaram, Ramesh Hariharan, Gustavo Morales, Philipp Sommer, Stewart Healy, Usman Siddiqui, Douglas Gibson, Kristina Chapman, Anne Sarver, Monica Lo
BACKGROUND: Catheter ablation is an established therapy for paroxysmal atrial fibrillation (PAF). The TactiFlex Ablation Catheter, Sensor Enabled (TactiFlex SE) is a next-generation radiofrequency ablation catheter incorporating fiber optics-based contact force-sensing technology with a flexible, laser-cut tip. OBJECTIVE: The study sought to evaluate the safety and effectiveness of the TactiFlex SE ablation catheter for treatment of drug-refractory PAF. METHODS: The TactiFlex AF investigational device exemption was a prospective, nonrandomized, multicenter clinical study...
December 2023: Heart rhythm O2