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- Sep 8, 202690% CONFIDENCEfrom the source
FDA Approves Abbott's TactiFlex Duo Ablation Catheter
- Abbott announced FDA approval of the TactiFlex Duo Ablation Catheter, Sensor Enabled, for challenging cases of atrial fibrillation, with broader commercial adoption across the U.S. in the coming weeks[1][2]
- The FDA approved it on 4 September 2026 as a panel-track supplement (S028) to the TactiFlex PMA P220013, for drug-refractory recurrent symptomatic paroxysmal atrial fibrillation and concomitant atrial flutter with a compatible RF or pulsed field generator and 3D mapping system[3]
- Physicians can use pulsed field ablation, radiofrequency energy or a combination in one procedure, and Abbott's EnSite X EP System gives real-time feedback on lesion formation through its PFA Index[1]
- In the FlexPulse study behind the approval, 180 patients underwent ablation with pulmonary vein isolation achieved in all; the primary safety endpoint rate was 1.7%, the primary effectiveness endpoint 74.6% at 12 months, and freedom from documented AF/AFL/AT recurrence 77.4%[4]
- Abbott calls it the company's fifth major electrophysiology approval in just over a year, after the Amulet 360 and TactiFlex Duo CE Marks this year and U.S. and European approvals of the Volt PFA System in 2025[1]
- TactiFlex Duo received CE Mark in Europe in January 2026 on the FOCALFLEX study, with the first EU commercial cases that week, and the FDA granted it Breakthrough Device Designation in October 2025 for treating ventricular tachycardia with PFA[5]
References 586% CONFIDENCE
The first entry is always the pin's source. Overall confidence is a weighted average of how firmly each reference supports the start and end times used above; a reference counts half as much for every 180 days older than the newest.
- [1]90%abbott.mediaroom.com/2026-09-08-Abbott-receives-FDA-approval-for-its-TactiFlex-TM-Duo-Ablation-Catheter-to-treat-people-with-abnormal-heart-rhythmsabbott.mediaroom.com· Posted Sep 23, 2026· Starts Sep 8, 2026 ✓· 24% of score
The release is datelined "ABBOTT PARK, Ill., Sept. 8, 2026" and says Abbott "announced today it has received U.S. Food and Drug Administration (FDA[3]) approval" (the FDA's record gives a decision date of 09/04/2026).
- [2]72%Abbott Gains FDA Approval for Dual-Energy Ablation Cathetermpo-mag.com· Published Sep 8, 2026· 23% of score
Medical Product Outsourcing's trade-press report of the approval and the U.S. rollout in the coming weeks.[1]
- [3]95%Premarket Approval (PMA) P220013/S028: TactiFlex Duo Ablation Catheter, Sensor Enabledaccessdata.fda.gov· Published Sep 4, 2026· 22% of score
The FDA's PMA database entry for the TactiFlex Duo panel-track supplement: applicant Abbott Medical, decision date 09/04/2026, and the approved indication.
- [4]88%Safety and Effectiveness of a Novel Dual-Energy Radiofrequency/Pulsed Field Ablation Catheter: 12 Month Results of the FlexPulse Study (EP Europace)academic.oup.com· Published Aug 29, 2026· 22% of score
The peer-reviewed FlexPulse results the release cites as the basis for FDA[3] approval, with the 12-month safety and effectiveness figures.
- [5]80%Abbott receives CE Mark for the TactiFlex Duo Ablation Catheter to treat patients with abnormal heart rhythmsabbott.mediaroom.com· Published Jan 20, 2026· 9% of score
Abbott's earlier release on the European CE Mark, the FOCALFLEX study and the October 2025 FDA[3] Breakthrough Device Designation for VT.
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