NORTH CHICAGO (dpa-AFX) - Abbott (ABT) said it has received CE Mark approval in Europe for its TactiFlex Duo Ablation Catheter, Sensor Enabled, for the treatment of atrial fibrillation (AFib).
The company noted that the first commercial cases using the device in the European Union were successfully completed this week.
TactiFlex Duo expands Abbott's pulsed field ablation (PFA) portfolio and is designed to deliver therapy lesions using two energy modalities, radiofrequency and PFA, allowing physicians to tailor treatment based on a patient's anatomy and clinical needs. Abbott said the catheter is intended to help reduce the risk of damage to adjacent tissue, particularly in patients with more complex disease.
The approval was supported by results from Abbott's FOCALFLEX CE Mark study, a global clinical trial conducted across the European Union, the United Kingdom and Australia, which demonstrated clinically meaningful safety and effectiveness outcomes in AFib patients.
Abbott said TactiFlex Duo integrates with its EnSite X EP System, which provides detailed three-dimensional heart mapping to help physicians identify and treat arrhythmia sources.
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