New data from Abbott has demonstrated longer-term safety and effectiveness of its TactiFlex Duo ablation catheter in treating atrial fibrillation (AFib), building on the system’s previous six-month clinical outcomes data.
Currently an investigational device in the US, TactiFlex Duo provides both pulse-field ablation (PFA) and radiofrequency (RF) ablation, providing physicians with more flexibility in treating AFib, Abbott stated.
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Abbott presented 12-month findings from the FlexPulse investigational device exemption (IDE) study of TactiFlex Duo during a late-breaking session at the 2026 European Society of Cardiology (ESC) congress in Munich, Germany.
The study met its primary effectiveness endpoint, with 74.6% of patient remaining free from documented arrhythmias, medication changes, or repeat procedures.
The 12-month data also demonstrated that 92.6% of patients did not have a documented recurrence of AFib, atrial flutter, or atrial tachycardia during follow-up when assessed using standard of care (SoC) monitoring.
Meanwhile, in protocol-driven monitoring, 77.4% of patients experienced no documented recurrence of AFib, atrial flutter, or atrial tachycardia during follow-up. The results add to previous six-month data with the system, which were also positive.
Ayman Hussein, director of cardiac electrophysiology research at Cleveland Clinic, who presented the late-breaking FlexPulse IDE data at ESC, said: “As physicians, we’re looking for technologies that help us confidently deliver the best possible outcomes for our patients, not just at the time of the procedure, but for years afterward.
“The evidence behind this device helps increase confidence in ablation therapy and hopefully support lasting outcomes for patients with atrial fibrillation.”
The FlexPulse study, the results of which have simultaneously been published in EP Europace, is intended to support TactiFlex Duo’s FDA approval. The dual ablation catheter, meanwhile, received a European CE mark in January 2026.
Duo represents an advancement on TactiFlex AF, Abbott’s RF-only ablation catheter that secured FDA clearance in May 2023.
Abbott, however, has already entered the rapidly growing PFA space, following its receipt of a European CE mark for its Volt system for treating patients with AFib in March 2025.
Research indicates that over 37 million people live with AFib worldwide, with this figure predicted to more than double by 2050.
GlobalData analysis reveals that the global electrophysiology devices market, of which ablation catheters such as TactiFlex are a part, is growing at a CAGR of 10.2% and is projected to reach a valuation of almost $25bn in 2035, up from around $9.4bn in 2025.
