Abbott Laboratories has secured U.S. Food and Drug Administration (FDA) clearance for its TactiFlex Duo catheter, a hybrid tool that merges pulsed field ablation (PFA) with radiofrequency energy to address atrial fibrillation (AFib). The new approval enables doctors to alternate between these energy sources during procedures, allowing them to adjust therapy based on individual patient requirements. The device already carries CE mark certification in Europe and is projected to strengthen Abbott’s position in the electrophysiology sector this year.
Atrial fibrillation, the most prevalent heart arrhythmia, raises stroke risk by disrupting regular heart rhythms. Data from the FlexPulse IDE study, shared at the European Society of Cardiology meeting in August, confirmed the TactiFlex Duo’s safety and effectiveness in treating paroxysmal AFib—a form characterized by intermittent irregular heartbeats. Early treatment can halt progression to longer episodes of AFib.
Radiofrequency ablation works by generating heat to form scar tissue that disrupts faulty electrical signals, while PFA uses targeted electrical pulses that reduce harm to surrounding tissue. Demand for PFA has surged as competitors including Boston Scientific, Medtronic, and Johnson & Johnson have introduced their own versions. Abbott’s earlier Volt PFA catheter, approved in the U.S. and Europe in 2025, forms part of its effort to reclaim market share in electrophysiology.
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The TactiFlex Duo’s ability to switch between modes may overcome weaknesses in current therapies. Though radiofrequency ablation remains the standard, PFA’s precision has gained favor, particularly in complex cases where limiting tissue damage is essential. Abbott’s leadership has stated that both the Volt and TactiFlex Duo could help the company exceed general market expansion in this area.
U.S. hospitals will begin using the TactiFlex Duo within weeks, reflecting Abbott’s broader initiative to incorporate advanced ablation tools into AFib management.
Abbott’s regulatory submission did not reveal pricing details or a rollout schedule, though the company has positioned its electrophysiology products as premium offerings. The TactiFlex Duo’s launch continues a pattern of steady advancements in AFib care, where combined approaches aim to enhance results while minimizing procedural complications.
