ABT · News · 20260909N

Regulatory Approval Milestones

ABBOTT LABORATORIES · 2026-09-09 · Importance 38 · Surprise 60

Abbott received U.S. FDA clearance for the TactiFlex Duo ablation catheter to treat atrial fibrillation. The catheter supports pulsed-field ablation, radio-frequency energy, or a combination of both, giving physicians multiple treatment options. The approval was supported by positive FlexPulse Identity study outcomes and represents Abbott’s fifth electrophysiology regulatory approval in just over one year, with a U.S. rollout expected soon.

Key facts

• Abbott recently received FDA approval for its TactiFlex Duo Ablation Catheter to treat atrial fibrillation. source
• The TactiFlex Duo approval marks Abbott's fifth electrophysiology regulatory nod in just over a year. source
• The approval for the TactiFlex Duo was based on positive outcomes from the FlexPulse Identity study. source