Dual-Energy Catheter Brings New Flexibility to AFib Ablation

Abbott has secured CE Mark approval for the TactiFlex Duo Ablation Catheter, Sensor-Enabled, for the treatment of atrial fibrillation (AFib). AFib is a common and progressive cardiac arrhythmia affecting an estimated eight million people in Europe over the age of 65, with prevalence expected to double over the next 30 years. The condition icreases the risk of stroke, heart failure, and mortality, highlighting the need for effective interventional therapies. The TactiFlex Duo Ablation Catheter is designed to address this growing clinical challenge by expanding treatment flexibility for irregular heart rhythms.

The effectiveness of cardiac ablation relies heavily on the quality of lesions created to interrupt abnormal electrical pathways. TactiFlex Duo enables tailored lesion creation using two energy modalities: radiofrequency ablation, which applies heat to destroy arrhythmogenic tissue, and pulsed field ablation (PFA), which uses high-energy electrical pulses to selectively destroy cells responsible for abnormal rhythms while potentially reducing damage to surrounding tissue in patients with complex anatomy or disease.

The catheter integrates with Abbott’s EnSite X EP System, which generates high-resolution three-dimensional maps of the heart to help physicians precisely locate and treat arrhythmia sources. Building on the previous generation’s flexible electrode tip and contact force-sensing technology, TactiFlex Duo now incorporates PFA energy delivery, supporting safer and more effective procedures.

CE Mark approval was supported by the FOCALFLEX study, a global clinical trial conducted at sites across the European Union, the United Kingdom, and Australia. The study demonstrated clinically meaningful safety and effectiveness outcomes in the treatment of atrial fibrillation. Enrollment in the FLEXPULSE Investigational Device Exemption trial in the United States was completed last year. In October 2025, the FDA granted Breakthrough Device Designation for the use of pulsed field ablation with the catheter to treat ventricular tachycardia.

Following CE Mark approval, the first commercial cases using TactiFlex Duo in the European Union were completed this week. The catheter expands Abbott’s pulsed field ablation portfolio by adding a dual-energy, focal ablation option alongside the Volt Pulsed Field Ablation System, which received both U.S. Food and Drug Administration and CE Mark approvals in 2025.

"TactiFlex Duo's most unique feature is its dual options that allow physicians to seamlessly switch treatment during a procedure based on the patient's personalized needs and anatomy. For patients who do not respond to medication and other traditional treatments, a successful cardiac ablation is critical as it can reduce the risk of recurrence of AFib and provide long-lasting relief," said Prof. Isabel Deisenhofer, M.D., head of the department of Electrophysiology at the German Heart Center Munich in Germany.

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