Abbott has announced late-breaking, 12-month data from the global FlexPulse investigational device exemption (IDE) study that show favourable safety and effectiveness outcomes for its investigational, sensor-enabled TactiFlex Duo ablation catheter to treat patients with challenging cases of atrial fibrillation (AF). These results were presented at the 2026 European Society of Cardiology (ESC) congress (28–31 August, Munich, Germany) and simultaneously published in EP Europace.
TactiFlex Duo is a dual-energy catheter designed to give physicians more flexibility when treating AF, offering both pulsed field ablation (PFA) and radiofrequency (RF) energy approaches to treatment—which, according to the company, can help a physician tailor therapy to a patient’s individual needs. Abbott’s EnSite X EP system also provides physicians with real-time feedback as an integrated mapping solution with the PFA Index (PI)—a tool designed to assess lesion formation during ablation with TactiFlex Duo.
The 12-month data presented at ESC 2026 showed positive outcomes in patients with paroxysmal AF. Key late-breaking findings from the FlexPulse IDE study include:
- A majority (92.6%) of patients did not have a documented recurrence of AF, atrial flutter or atrial tachycardia during follow-up when assessed using standard-of-care monitoring
- In protocol-driven monitoring, which follows more rigorous, heart rhythm assessments throughout the study, 77.4% of patients experienced no documented recurrence of AF, atrial flutter or atrial tachycardia during follow-up
- The study met its primary effectiveness endpoint, with 74.6% of patients remaining free from documented arrhythmias, medication changes or repeat procedures
- The study reported a consistently high patient safety profile (98.3%) with no major safety events
“As physicians, we’re looking for technologies that help us confidently deliver the best possible outcomes for our patients—not just at the time of the procedure, but for years afterward,” said Ayman Hussein (Cleveland Clinic, Cleveland, USA), who presented these data at ESC 2026. “The evidence behind this device helps increase confidence in ablation therapy and hopefully supports lasting outcomes for patients with AF.”
The FlexPulse IDE study was designed to secure US Food and Drug Administration (FDA) approval for the TactiFlex Duo catheter, which received a CE mark in Europe earlier this year.
