TactiFlex Duo joins Johnson & Johnson MedTech’s ThermoCool SmartTouch SF and Medtronic’s Affera Sphere-9 catheter in the U.S. dual-energy ablation catheter market. Medtronic won its Sphere-9 approval in 2024, and J&J earned FDA approval for its system in July 2026. (In August, Affera Sphere-9 earned an expanded CE mark indication to treat ventricular arrhythmias.)
The dual-energy system enables electrophysiologists to toggle between pulsed-field ablation (PFA) and radiofrequency (RF) energy to treat patients with difficult atrial fibrillation cases.