ABT · News · 20260902N

Regulatory Approval Milestones

ABBOTT LABORATORIES · 2026-09-02 · Importance 41 · Surprise 60

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 plans to use the FlexPulse IDE study results for FDA approval in the U.S. source
• Abbott's TactiFlex Duo achieved its primary effectiveness endpoint in the FlexPulse IDE study, with 74.6% of patients remaining free from documented arrhythmias one year after treatment. source