The Investor
08 Sep 2026, 17:32
Abbott Wins FDA Approval for TactiFlex Duo Ablation Catheter to Treat Atrial Fibrillation
Abbott (NYSE: ABT) received U.S. Food and Drug Administration approval for its TactiFlex Duo Ablation Catheter, expanding the company’s portfolio of cardiac ablation technologies for treating atrial fibrillation.
TactiFlex Duo combines pulsed field ablation (PFA) and radiofrequency (RF) energy in a single catheter, allowing physicians to use either energy source or a combination of both when treating complex AFib cases. Abbott said the flexibility can help physicians tailor procedures to individual patients while minimizing the impact on surrounding healthy tissue.
The catheter also integrates with Abbott’s EnSite X EP System, which provides real-time three-dimensional mapping and feedback during procedures.
FDA approval was supported by results from Abbott’s FlexPulse IDE study. Data recently presented at the European Society of Cardiology Congress 2026 showed favorable safety and effectiveness outcomes in patients with paroxysmal AFib.
The approval strengthens Abbott’s position in the rapidly developing PFA market and follows other recent cardiac ablation approvals across the U.S., Europe, Asia and Latin America.
Abbott plans to begin initial U.S. procedures soon, followed by broader commercial adoption in the coming weeks. The launch adds another treatment option to Abbott’s electrophysiology portfolio as the company expands its presence in technologies used to diagnose, map and treat abnormal heart rhythms.
Abbott (NYSE: ABT) received U.S. Food and Drug Administration approval for its TactiFlex Duo Ablation Catheter, expanding the company’s portfolio of cardiac ablation technologies for treating atrial fibrillation.
TactiFlex Duo combines pulsed field ablation (PFA) and radiofrequency (RF) energy in a single catheter, allowing physicians to use either energy source or a combination of both when treating complex AFib cases. Abbott said the flexibility can help physicians tailor procedures to individual patients while minimizing the impact on surrounding healthy tissue.
The catheter also integrates with Abbott’s EnSite X EP System, which provides real-time three-dimensional mapping and feedback during procedures.
FDA approval was supported by results from Abbott’s FlexPulse IDE study. Data recently presented at the European Society of Cardiology Congress 2026 showed favorable safety and effectiveness outcomes in patients with paroxysmal AFib.
The approval strengthens Abbott’s position in the rapidly developing PFA market and follows other recent cardiac ablation approvals across the U.S., Europe, Asia and Latin America.
Abbott plans to begin initial U.S. procedures soon, followed by broader commercial adoption in the coming weeks. The launch adds another treatment option to Abbott’s electrophysiology portfolio as the company expands its presence in technologies used to diagnose, map and treat abnormal heart rhythms.
