Abbott (NYSE: ABT) has received CE Mark approval in Europe for its TactiFlex™ Duo Ablation Catheter, Sensor Enabled™, expanding treatment options for patients with atrial fibrillation (AFib). Following the approval, physicians successfully completed the first commercial procedures using TactiFlex Duo across the European Union this week.
Dual-Energy Technology for Personalised AFib Treatment
TactiFlex Duo represents the latest advancement in Abbott’s pulsed field ablation (PFA) portfolio. Cardiac ablation relies on creating precise, durable lesions to stop irregular heart rhythms. With this catheter, physicians can deliver therapy using two complementary energy sources during a single procedure.
Specifically, the catheter offers radiofrequency ablation, which uses heat to destroy arrhythmia-causing tissue, and pulsed field ablation, which uses high-energy electrical pulses to selectively target abnormal heart cells while reducing the risk of damage to surrounding tissue. As a result, physicians can tailor treatment in real time based on individual anatomy and disease complexity.
Physician Experience Highlights Clinical Value
Commenting on the approval, Prof. Isabel Deisenhofer, M.D., Head of Electrophysiology at the German Heart Center Munich, said the catheter’s ability to switch seamlessly between energy types allows physicians to personalise therapy during procedures. She added that effective ablation remains critical for patients who do not respond to medication, as it can reduce AFib recurrence and deliver long-term symptom relief.
Strong Clinical Evidence Supports Approval
Abbott supported the CE Mark approval with data from its FOCALFLEX CE Mark study, a global clinical trial conducted across the European Union, the United Kingdom, and Australia. The study demonstrated clinically meaningful safety and effectiveness outcomes in treating patients with AFib.
This innovation arrives at a critical time. Nearly eight million Europeans over the age of 65 live with AFib, a figure expected to double over the next three decades. AFib significantly increases the risk of stroke, heart failure, and mortality, making effective intervention essential.
Integrated Mapping and Expanding Regulatory Momentum
As per the Abbott press release, TactiFlex Duo integrates with Abbott’s EnSite™ X EP System, which provides high-resolution, three-dimensional heart mapping to precisely locate and treat arrhythmias. Moreover, the approval marks Abbott’s third major electrophysiology milestone in under a year, following FDA and CE Mark approvals for its Volt™ PFA System in 2025.
Looking ahead, Abbott continues to advance its pipeline, with U.S. trials completed and FDA Breakthrough Device Designation granted for ventricular tachycardia treatment—reinforcing its commitment to expanding safe, personalised arrhythmia care.