FDA Approves Abbott’s Dual-Energy Ablation Catheter for Atrial Fibrillation

Abbott has received approval from the U.S. Food and Drug Administration (FDA) for its TactiFlex Duo Ablation Catheter, a cardiac device designed to provide physicians with greater flexibility while treating patients with atrial fibrillation (AFib).

The device brings two established ablation approaches—pulsed field ablation (PFA) and radiofrequency (RF) energy—into a single catheter. Physicians can select either energy source or use both during a procedure, depending on the patient's condition and treatment requirements.

Atrial fibrillation is a common heart rhythm disorder that can increase the risk of serious complications, including stroke. Cardiac ablation is used to target areas of heart tissue responsible for abnormal electrical signals. While RF ablation uses thermal energy to create therapeutic lesions, PFA relies on electrical pulses and is designed to limit damage to surrounding healthy tissue.

FDA approval was supported by results from Abbott's FlexPulse IDE study involving patients with symptomatic, recurrent and drug-refractory paroxysmal AFib. The clinical findings demonstrated favourable safety and effectiveness outcomes. Abbott's catheter can also work with the company's EnSite X mapping system, providing physicians with three-dimensional cardiac mapping and real-time information during treatment.

The regulatory clearance represents another important development in the rapidly evolving field of electrophysiology. TactiFlex Duo had already received CE Mark approval in Europe earlier in 2026.

The development provides a useful example of how clinical evidence, device innovation and regulatory evaluation come together before an advanced medical technology reaches wider clinical use.

10-09-2026