Abbott announced this week that it has received a CE mark in Europe for the sensor-enabled TactiFlex Duo ablation catheter to treat patients with atrial fibrillation (AF). Following this new approval, the first successful commercial cases using TactiFlex Duo in the EU have also been completed.
“TactiFlex Duo’s most unique feature is its dual option allowing physicians to seamlessly switch treatment during a procedure based on the patient’s personalised needs and anatomy,” said Isabel Deisenhofer (German Heart Center Munich, Munich, Germany), one of the first physicians to use TactiFlex Duo following its 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 AF and provide longlasting relief.”
The TactiFlex Duo catheter is the latest advancement in Abbott’s pulsed field ablation (PFA) technology portfolio. As stated in a recent press release from the company, an effective cardiac ablation relies on the quality of the lesions created by a catheter to stop the source of an arrhythmia. TactiFlex Duo is designed to deliver tailored therapy lesions in two ways: radiofrequency energy using heat to destroy tissue responsible for erratic heart signals, and PFA energy using electrical pulses to destroy the cells causing abnormal heart rhythms, which can also reduce the risk of damaging adjacent tissue in patients with complex disease or anatomies.
CE-mark approval for the TactiFlex Duo catheter was supported by data from Abbott’s FOCALFLEX CE-mark study—a global clinical trial conducted at centres in the EU, UK and Australia. In the trial, TactiFlex Duo demonstrated a “clinically meaningful performance” in terms of safety and effectiveness in the treatment of AF patients.
“AF 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 (Sussex Cardiac Centre, Brighton, UK), 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.”
According to Abbott, TactiFlex Duo marks the third significant approval from the company’s electrophysiology (EP) portfolio in less than a year, with its Volt PFA system having received US Food and Drug Administration (FDA) and CE-mark approvals in 2025.
“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 coexisting heart disease and heart failure, long-lasting AF, ventricular arrhythmias, and patients with a history of failed ablations,” said Christopher Piorkowski, chief medical officer of Abbott’s EP 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.”
Enrolment for Abbott’s FLEXPULSE investigational device exemption (IDE) trial evaluating TactiFlex Duo for the treatment of AF in the USA was completed last year, with the US FDA having also granted the catheter a Breakthrough Device designation for the treatment of ventricular tachycardia in October 2025.
