Abbott has received CE Mark in Europe for the TactiFlex Duo Ablation Catheter, Sensor Enabled to treat patients with atrial fibrillation (AFib). Following the new approval, the first successful commercial cases using TactiFlex Duo in the European Union were completed this week.
TactiFlex Duo is designed to deliver tailored therapy lesions in two ways: radiofrequency energy (uses heat to destroy tissue responsible for erratic heart signals), and pulsed field ablation energy (uses high energy electrical pulses to destroy the cells causing abnormal heart rhythms, which can reduce the risk of damaging adjacent tissue in patients with complex disease or anatomy).
TactiFlex Duo integrates with Abbott's EnSite X EP System, which creates three-dimensional maps of the heart to help doctors find and treat the source of the arrhythmia. The technology builds on the catheter's previous generation flexible electrode tip and contact force sensing to now include PFA energy delivery, resulting in more effective and safer procedures.
TactiFlex Duo marks the third significant approval in Abbott's electrophysiology portfolio in less than a year. The company's Volt PFA System received FDA and CE Mark approvals in 2025.
