Abbott has earned CE mark clearance for its TactiFlex Duo Catheter, Sensor Enabled to treat patients with atrial fibrillation (AFib). After the approval, the first successful commercial cases using TactiFlex Duo in the EU were completed this week.

The TactiFlex Duo catheter is the latest in the company’s pulsed field ablation (PFA) technology portfolio. It’s designed to deliver tailored therapy lesions in two ways: radiofrequency energy, which uses heat to destroy tissue responsible for erratic heart signals, and pulsed field ablation energy, which uses high energy electrical pulses to destroy the cells causing abnormal heart rhythms (this can lower the risk of damaging adjacent tissue in patients with complex disease or anatomy).

“TactiFlex Duo’s most unique feature is its dual options that allow physicians to seamlessly switch treatment during a procedure based on the patient’s personalized needs and anatomy,” said Prof. Isabel Deisenhofer, MD, head of the department of Electrophysiology at the German Heart Center Munich in Germany, and one of the first physicians to use TactiFlex Duo following CE mark approval. “For patients who do not respond to medication and other traditional treatments, a successful cardiac ablation is critical as it can reduce the risk of recurrence of AFib and provide long-lasting relief.”

The EU nod was supported by Abbott’s FOCALFLEX CE mark study, a clinical trial conducted at centers in the EU, UK, and Australia. The trial demonstrated that TactiFlex Duo showed clinically meaningful performance in the safety and effectiveness of treating AFib patients.

The catheter integrates with the company’s EnSite X EP system, which creates detailed 3D maps of the heart to help clinicians find and treat the source of arrhythmia. The tech builds on TactiFlex Duo’s previous generation flexible electrode tip and contact force sensing to now include PFA energy delivery.

“AFib is a progressive disease that becomes harder to treat over time, and there is not a one-size-fits all approach, which makes long-term management complex,” said John Silberbauer, MD, electrophysiologist at the Sussex Cardiac Centre in Brighton, United Kingdom, who treated patients as part of the FOCALFLEX study. “TactiFlex Duo allows me to safely tailor each ablation treatment to the patient’s anatomy, and results show that it consistently improves symptoms and quality of life for many.”

This marks the third significant approval in Abbott’s electrophysiology portfolio in under a year. The company’s Volt PFA system earned U.S. Food and Drug Administration (FDA) and CE mark approvals in 2025.

Enrollment for the company’s FLEXPULSE IDE trial to assess TactiFlex Duo to treat AFib in the U.S. was completed last year. In October 2025, the FDA awarded it breakthrough device status to treat ventricular tachycardia (VT) using PFA.

“The TactiFlex Duo Catheter provides another advanced tool to Abbott’s growing PFA portfolio for treating patients with more complex cases such as those with co-existing heart disease and heart failure, long-lasting AFib, ventricular arrhythmias and patients with a history of failed ablations,” said Christopher Piorkowski, MD, chief medical officer of Abbott’s electrophysiology business. “By focusing on a holistic view of patient care, physicians now have multiple clinically proven tools to enhance workflow and to effectively treat a wide range of arrhythmias.”