By: IPP Bureau
Last updated : September 10, 2026 7:42 am
With TactiFlex Duo, Abbott is adding a dual RF-PFA platform to its US portfolio as medical device companies compete to capture a growing share of the AFib ablation market
The US Food and Drug Administration (FDA) has approved Abbott’s TactiFlex Duo, a dual-technology ablation catheter for the treatment of atrial fibrillation (AFib), expanding the company’s pulsed-field ablation (PFA) portfolio in the US.
TactiFlex Duo combines radiofrequency (RF) ablation and pulsed-field ablation (PFA) in a single catheter, giving physicians greater flexibility in selecting an ablation approach during AFib procedures.
The catheter is designed to work with Abbott’s EnSite X EP System, an integrated mapping platform that provides real-time procedural feedback. It also incorporates Abbott’s PFA Index (PI), a tool designed to assess lesion formation during PFA procedures.
Uri Yaron, Senior Vice President of Abbott’s Electrophysiology business, described the FDA clearance as an important advancement in the company’s efforts to build a comprehensive electrophysiology portfolio.
“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,” Yaron said.
TactiFlex Duo builds on Abbott’s TactiFlex RF ablation catheter, which received FDA clearance in May 2023. The new device is Abbott’s second PFA catheter to receive US approval, following the Volt PFA System, which was cleared in December 2025. Volt received its European CE mark in March 2025.
The latest approval is supported by data from Abbott’s FlexPulse investigational device exemption (IDE) study. Twelve-month data presented at the 2026 European Society of Cardiology (ESC) Congress in Munich showed that the study met its primary effectiveness endpoint, with 74.6% of patients remaining free from documented arrhythmias, medication changes or repeat procedures at 12 months.
Alongside Abbott, Boston Scientific, Medtronic and Johnson & Johnson have commercialised PFA systems, with the technology becoming an increasingly important driver of electrophysiology sales.
Abbott CEO Robert Ford had earlier indicated that TactiFlex Duo would support the company’s efforts to maintain its position in the competitive electrophysiology market.
The broader global electrophysiology devices market is also expanding rapidly. According to GlobalData analysis, the market is projected to grow at a compound annual growth rate of 10.2%, reaching nearly US$25 billion by 2035, compared with approximately US$9.4 billion in 2025.