Abbott’s TactiFlex Duo shows strong 12 month outcomes in paroxysmal atrial fibrillation study

Abbott has reported new 12 month findings from the FlexPulse Global IDE study evaluating its investigational TactiFlex Duo Ablation Catheter, Sensor Enabled, in patients with paroxysmal atrial fibrillation.

The late breaking data, presented at the European Society of Cardiology Congress 2026 in Munich and published simultaneously in EP Europace, showed favourable safety and effectiveness outcomes for the dual energy ablation technology.

TactiFlex Duo combines pulsed field ablation and radiofrequency energy within a single catheter, giving physicians the option to use different energy approaches according to an individual patient’s treatment needs.

The system can also be used with Abbott’s EnSite X EP System, which provides real time procedural feedback through an integrated mapping platform. This includes the PFA Index, which is designed to help assess lesion formation during procedures performed with TactiFlex Duo.

Both pulsed field ablation and radiofrequency ablation are used to create small areas of scar tissue that interrupt the abnormal electrical activity responsible for irregular heart rhythms. By targeting these signals while limiting effects on surrounding healthy tissue, ablation can help restore a more normal heart rhythm in people with atrial fibrillation.

At 12 months, 92.6% of patients had no documented recurrence of atrial fibrillation, atrial flutter or atrial tachycardia when outcomes were assessed using standard of care monitoring.

Under the study’s protocol driven monitoring approach, which involved more intensive heart rhythm assessment during follow up, 77.4% of patients remained free from documented recurrence of atrial fibrillation, atrial flutter or atrial tachycardia.

The FlexPulse IDE study also met its primary effectiveness endpoint. A total of 74.6% of participants remained free from documented arrhythmias, medication changes or repeat procedures.

Safety findings showed that 98.3% of patients met the study’s safety measure, with no major safety events reported.

Ayman Hussein, M.D., director of the Atrial Fibrillation Center and director of Cardiac Electrophysiology Research at Cleveland Clinic, presented the findings at the European Society of Cardiology Congress.

Hussein said physicians are looking for technologies that can support strong outcomes not only during the ablation procedure itself but over the longer term. He said the evidence generated for TactiFlex Duo could strengthen confidence in ablation therapy and support more durable outcomes for people living with atrial fibrillation.

The FlexPulse IDE study was designed to support an application for US Food and Drug Administration approval of TactiFlex Duo. The catheter received CE Mark approval in Europe earlier in 2026.

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Abbott, Atrial Fibrillation, cardiology, clinical trials, Electro physiology, medical devices, pharma news, TactiFlex