Abbott Receives FDA Approval for TactiFlex Duo Catheter

Abbott has received approval from the US Food and Drug Administration (FDA) for its TactiFlex™ Duo Ablation Catheter, Sensor Enabled™, for treating patients with challenging cases of atrial fibrillation (AFib).

The dual-energy catheter is the latest addition to Abbott’s cardiac ablation portfolio and allows physicians to use pulsed field ablation (PFA), radiofrequency (RF) energy or a combination of both during a procedure. 

This flexibility is designed to support personalised treatment for patients with complex heart rhythms.

TactiFlex Duo can be used with Abbott’s EnSite™ X EP System, which provides real-time mapping during cardiac ablation. 

The system also incorporates the PFA Index, a tool designed to help assess lesion formation during treatment.

The FDA approval was supported by results from Abbott’s FlexPulse IDE study. 

Data presented at the European Society of Cardiology Congress 2026 and published in Europace reported favourable safety and effectiveness outcomes in patients with paroxysmal AFib.

The approval further expands Abbott’s pulsed field ablation portfolio in the US and represents its fifth major electrophysiology approval in just over a year. 

The company plans to begin broader commercial use of TactiFlex Duo across the US in the coming weeks.

The development adds to Abbott’s growing range of technologies for diagnosing, mapping and treating cardiac arrhythmias.