The US Food and Drug Administration (FDA) has approved Abbott’s TactiFlex Duo, a dual ablation catheter indicated for the treatment of atrial fibrillation (AFib).
TactiFlex Duo provides both radiofrequency (RF) ablation and pulsed-field ablation (PFA), providing clinicians with greater optionality when undertaking AFib procedures. The catheter functions alongside Abbott’s EnSite X EP System, which provides clinicians with real-time feedback as an integrated mapping solution with the PFA Index (PI), a tool designed to assess lesion formation during ablation procedures.
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Uri Yaron, senior vice president of Abbott’s electrophysiology business asserted that FDA clearance for TactiFlex Duo represents an “important advancement” towards the company’s aim to develop the industry’s “most comprehensive” electrophysiology portfolio. In a Q2 earnings call earlier this year, Abbott’s CEO Robert Ford said the device would help the company maintain competitive electrophysiology market share.
TactiFlex Duo represents an ideation on Abbott’s TactiFlex, an RF-only ablation catheter that obtained FDA clearance in May 2023. Meanwhile, Duo is the company’s second PFA catheter approved in the US, following the approval of its Volt PFA system in December 2025. Volt secured a European CE mark in March 2025.
Yaron continued: “By continuing to expand our PFA portfolio and integrate innovative technologies across cardiovascular care, we’re helping physicians navigate increasingly complex procedures while ensuring more patients receive the right care at the right time.”
The FDA greenlight for TactiFlex Duo was supported by data from Abbott’s FlexPulse investigational device exemption (IDE) study.
Late-breaking 12-month data from the study was recently presented 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 at 12 months.
The 12-month data also demonstrated that 92.6% of patients had no documented recurrence of AFib, atrial flutter, or atrial tachycardia during follow-up when assessed using standard of care (SoC) monitoring.
While the PFA marketplace remains small in terms of approved products, it is highly competitive, due in large part to its vast addressable patient population. Research indicates that over 37 million people live with AFib worldwide, with this figure predicted to more than double by 2050. Alongside Abbott, Boston Scientific, Medtronic, and J&J all have marketed PFA systems. PFA systems are spurring many of these companies’ electrophysiology sales given strong adoption for the technology.
GlobalData analysis reveals that the global electrophysiology devices market, of which ablation catheters such as TactiFlex Duo 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.
