ABT · News · 20260908N
Regulatory Approval Milestones
ABBOTT LABORATORIES · 2026-09-08 · Importance 41 · Surprise 60 · In source text
Abbott received U.S. FDA approval for the TactiFlex™ Duo Ablation Catheter, Sensor Enabled™, for treating patients with challenging atrial fibrillation (AFib) cases. The catheter combines pulsed field ablation (PFA) and radiofrequency (RF) energy in a single device, strengthening Abbott’s electrophysiology and cardiac-ablation portfolio. In the FlexPulse IDE study, 74.6% of patients remained free from documented arrhythmias at one year, while Abbott said its PFA portfolio has also received recent approvals in Europe, Asia and Latin America.
Key facts
- Abbott received U.S. Food and Drug Administration (FDA) approval for the TactiFlex™ Duo Ablation Catheter, Sensor Enabled on Sept. 8, 2026. source
- The TactiFlex™ Duo Ablation Catheter, Sensor Enabled combines pulsed field ablation (PFA) and radiofrequency (RF) energy in a single catheter. source
- FDA approval of TactiFlex Duo strengthens Abbott's expanding PFA portfolio following recent cardiac ablation approvals in the U.S., Europe, Asia and Latin America. source
Impact estimates
| metric | direction | stage | expected | basis |
|---|---|---|---|---|
| revenue | positive | probable | — | Abbott received U.S. Food and Drug Administration (FDA) approval for the TactiFlex™ Duo Ablation Catheter, Sensor Enabled on Sept. 8, 2026. |