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Abbott's Duo Catheter Shows Lasting AFib Treatment
1 Sep
Summary
- TactiFlex Duo demonstrated 12-month safety and effectiveness in AFib treatment.
- The device offers both pulse-field and radiofrequency ablation capabilities.
- Study met primary endpoint, with high patient freedom from arrhythmias.
New 12-month findings from Abbott's FlexPulse investigational device exemption study highlight the longer-term safety and effectiveness of the TactiFlex Duo ablation catheter for treating atrial fibrillation (AFib). Presented at the 2026 European Society of Cardiology (ESC) congress in Munich, Germany, the data showed the device met its primary effectiveness endpoint.
A significant 74.6% of patients remained free from documented arrhythmias, medication changes, or repeat procedures. Furthermore, 92.6% of patients experienced no recurrence of AFib, atrial flutter, or atrial tachycardia using standard monitoring.
This dual-action catheter, which provides both pulse-field ablation (PFA) and radiofrequency (RF) ablation, is currently investigational in the US but has received a European CE mark. The study results, also published in EP Europace, are intended to support the device's FDA approval.
Abbott has also been active in the PFA market, having received a CE mark for its Volt system in March 2025. The TactiFlex Duo represents an advancement over Abbott's RF-only TactiFlex AF catheter, cleared by the FDA in May 2023.
With over 37 million people worldwide affected by AFib, predicted to double by 2050, the development of effective treatment options like TactiFlex Duo is critical. The global electrophysiology devices market is projected to reach nearly $25 billion by 2035.
