Abbott has received CE Mark approval in Europe for the TactiFlex Duo Ablation Catheter, Sensor Enabled, for the treatment of patients with Atrial Fibrillation (AFib). Following the regulatory clearance, the first successful commercial procedures using the catheter have been completed in the European Union.

TactiFlex Duo represents the latest advancement in Abbott’s Pulsed Field Ablation (PFA) technology portfolio. The catheter is designed to create high-quality ablation lesions through two complementary energy modalities RadioFrequency (RF) energy, which uses heat to destroy arrhythmia-causing tissue, and pulsed field ablation energy, which uses electrical pulses to selectively target cardiac cells while reducing the risk of damage to surrounding structures.

The catheter’s dual-energy capability allows physicians to seamlessly switch between RF and PFA during a procedure, enabling a more personalised approach based on patient anatomy and disease complexity. According to Prof. Isabel Deisenhofer, MD, Head of Electrophysiology at the German Heart Centre Munich, this flexibility is particularly valuable for patients who do not respond to medication or conventional treatments, helping reduce AFib recurrence and improve long-term outcomes.

CE Mark approval was supported by data from Abbott’s global Focalflex clinical study conducted across sites in the European Union, the United Kingdom and Australia. The trial demonstrated clinically meaningful safety and effectiveness of the TactiFlex Duo catheter in treating AFib.

AFib affects an estimated eight million Europeans aged over 65, a figure expected to double over the next three decades. The condition significantly increases the risk of stroke, heart failure and mortality, making effective ablation therapies critical for disease management.

TactiFlex Duo integrates with Abbott’s EnSite X EP System, which provides high-resolution three-dimensional cardiac mapping to help physicians accurately identify and treat arrhythmia sources. The system builds on the catheter’s flexible electrode design and contact force sensing, now enhanced with PFA energy delivery for improved procedural safety and efficiency.

The approval marks the third major regulatory milestone for Abbott’s electrophysiology portfolio in under a year, following FDA and CE Mark approvals for the Volt PFA System in 2025. Abbott continues to expand its PFA pipeline, with ongoing clinical development in the US and a Breakthrough Device Designation from the FDA for ventricular tachycardia treatment, underscoring the company’s focus on addressing complex and life-threatening cardiac arrhythmias.