Abbott has gained a CE mark in the European Union (EU) for the TactiFlex Duo ablation catheter, representing the company’s latest addition to its growing pulsed-field ablation (PFA) portfolio for atrial fibrillation (AFib) treatment.
TactiFlex Duo is a new version of Abbott’s TactiFlex radiofrequency (RF) ablation catheter, which gained US Food and Drug Administration (FDA) clearance in 2023. This original version contributed towards sales in Abbott’s electrophysiology business of around $2.46bn in 2024.
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As the name suggests, the new version of TactiFlex allows for irregular heart rhythms to be addressed in two ways.
TactiFlex Duo can ablate using RF or PFA to destroy cells responsible for irregular heart rhythms. Surgeons can also readily switch between the two treatment modalities during a procedure, depending on an individual patient’s needs.
Abbott’s CE mark designation was supported by data from the medtech giant’s FOCALFLEX study, wherein TactiFlex Duo demonstrated its safety and effectiveness in treating AFib patients.
While TactiFlex Duo is not yet available on the US market, the system gained a breakthrough device designation from the FDA for the treatment of ventricular tachycardia (VT) using PFA in October 2025.
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By GlobalData“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, 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,” Piorkowski added.
The CE mark for TactiFlex Duo follows Abbott’s Volt PFA catheter’s earlier-than-anticipated CE mark designation in the EU and subsequent FDA clearance for AFib treatment in December 2025.
Volt’s entry onto the EU market represented Abbott’s first foray into the increasingly popular PFA space, a sub-segment of the electrophysiology devices market that is growing at a CAGR of 11.2% and projected to reach a valuation of over $23bn in 2034, as per GlobalData analysis.
Volt’s US market approval came more than a year after rivals Johnson & Johnson (J&J) and Boston Scientific, who gained FDA clearance for their respective Varipulse and Farapulse PFA systems in early 2024. Medtronic became the first entrant in the US PFA space after securing FDA clearance for its PulseSelect system in December 2023.
At the recent J.P. Morgan Healthcare Conference, Boston Scientific reported strong financial performance for its PFA portfolio, with 15% growth expected to continue for at least another three years.
According to a GlobalData market model, in 2025, J&J held a commanding 43.1% share of the US electrophysiology ablation catheter market, followed by Boston and Medtronic in second and third position with market shares of 25.6% and 24.6%, respectively. However, GlobalData currently places Boston Scientific as the US market leader for PFA devices.
