Abbott has received CE Mark approval in Europe for its TactiFlex™ Duo Ablation Catheter, Sensor Enabled™, designed to treat patients with atrial fibrillation (AFib). The first commercial procedures using the catheter in the European Union have already been successfully completed.
TactiFlex Duo is a dual-energy, focal ablation catheter that delivers both radiofrequency (RF) energy and pulsed field ablation (PFA) energy, enabling physicians to target irregular heart rhythms with tailored therapy. The device is intended for patients who do not respond to medication or other conventional treatments, offering safer and more effective ablation by minimizing damage to surrounding tissue in complex cardiac cases.
The CE Mark approval is based on data from Abbott’s FOCALFLEX CE Mark study, a global clinical trial conducted across centers in the European Union, the United Kingdom, and Australia. The study demonstrated clinically meaningful safety and efficacy outcomes for treating AFib with the TactiFlex Duo catheter.
AFib affects approximately eight million Europeans over the age of 65, a number projected to double over the next three decades. The condition increases the risk of stroke, heart failure, and mortality, and cardiac ablation remains a critical treatment option for symptom relief and long-term disease management.
The catheter integrates with Abbott’s EnSite™ X EP System, which provides detailed three-dimensional cardiac mapping to assist physicians in identifying arrhythmia sources. Enhancements to the TactiFlex Duo include flexible electrode tips, contact force sensing, and PFA energy delivery, which together improve procedural precision and patient safety.
This approval adds to Abbott’s growing pulsed field ablation (PFA) portfolio, which includes the Volt PFA System, approved by the FDA and CE Mark in 2025. Abbott is also conducting the FLEXPULSE IDE trial in the U.S. to further evaluate TactiFlex Duo for AFib treatment, and the catheter has received FDA Breakthrough Device Designation for potential treatment of life-threatening ventricular tachycardia (VT).
With this dual-energy catheter, Abbott expands treatment options for patients with complex arrhythmias, including those with co-existing heart conditions, long-lasting AFib, ventricular arrhythmias, and prior failed ablations, while supporting more effective and personalized cardiac care.
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