Abbott receives CE Mark for the TactiFlex™ Duo Ablation Catheter to treat patients with abnormal heart rhythms

Core Viewpoint - Abbott has received CE Mark approval for the TactiFlex™ Duo Ablation Catheter, which is designed to treat patients with atrial fibrillation (AFib) in Europe, marking a significant advancement in cardiac ablation technology [1][4]. Product Overview - The TactiFlex Duo Catheter utilizes pulsed field ablation (PFA) technology and offers dual options for treatment: radiofrequency energy and pulsed field ablation energy, allowing for tailored therapy lesions [2][8]. - This catheter is designed to improve the effectiveness of cardiac ablation procedures by minimizing damage to adjacent tissues, particularly in patients with complex disease or anatomy [2][6]. Clinical Significance - Approximately eight million Europeans over the age of 65 are living with AFib, a number expected to double in the next 30 years, highlighting the growing need for effective treatment options [5]. - Successful cardiac ablation can significantly reduce the risk of AFib recurrence and improve patients' quality of life, especially for those who do not respond to traditional treatments [3][6]. Regulatory Progress - The TactiFlex Duo represents the third major approval in Abbott's electrophysiology portfolio within a year, following the Volt PFA System's approvals in 2025 [7]. - The CE Mark approval was supported by data from the FOCALFLEX CE Mark study, which demonstrated the catheter's safety and effectiveness in treating AFib [4]. Integration with Existing Technology - TactiFlex Duo integrates with Abbott's EnSite™ X EP System, which provides detailed three-dimensional mapping of the heart, enhancing the precision of arrhythmia treatment [6]. - This integration allows for a more comprehensive approach to patient care, enabling physicians to utilize multiple clinically proven tools for a wide range of arrhythmias [9].