FDA approves Abbott TactiFlex Duo dual-energy ablation catheter for atrial fibrillation
The FDA has approved Abbott's TactiFlex Duo Ablation Catheter, a dual-energy system combining pulsed-field ablation and radiofrequency energy for the treatment of atrial fibrillation.
The catheter allows electrophysiologists to use pulsed-field ablation, radiofrequency energy or a combination of both during the same procedure, providing additional flexibility when treating challenging AFib cases.
The approval was supported by Abbott's FlexPulse IDE study and expands the company's US pulsed-field ablation portfolio, with broader commercial adoption planned in the coming weeks.
Field | Content |
Alert Type | Approval |
Device Name | TactiFlex Duo Ablation Catheter, Sensor Enabled |
Company | Abbott |
Regulatory Authority | U.S. Food and Drug Administration |
Approval Type | Medical device approval |
Indication | Treatment of patients with challenging cases of atrial fibrillation |
Technology or Modality | Dual-energy cardiac ablation catheter using pulsed-field ablation and radiofrequency energy |
Therapy Area(s) | Cardiology; electrophysiology |
Geography | United States |
What Happened | The FDA approved Abbott's TactiFlex Duo Ablation Catheter for the treatment of atrial fibrillation. |
Why It Matters | The device combines pulsed-field ablation and radiofrequency energy in a single catheter, allowing physicians to select or combine energy modalities during an AFib ablation procedure. |
Supporting Context | The approval was supported by results from Abbott's FlexPulse IDE study, which evaluated safety and effectiveness in patients with paroxysmal atrial fibrillation. |
Key Takeaway | FDA approval of TactiFlex Duo gives US electrophysiologists a new dual-energy ablation catheter for treating complex atrial fibrillation cases. |
What to Watch | US commercial rollout and adoption of dual-energy ablation strategies across electrophysiology centres. |
Primary Source | Abbott |
Relevant Date | 8 September 2026 |
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