Abbott Unveils New Data for TactiFlex Duo, HeartMate 3

Abbott revealed new late-breaking 12-month data from the FlexPulse IDE study of its TactiFlex Duo ablation catheter, Sensor Enabled at this week’s European Society of Cardiology (ESC) Congress in Munich, Germany. The data was also published in the journal EP Europace.

TactiFlex Duo is an investigational dual-energy catheter designed to treat AFib using either pulsed field ablation (PFA) or radiofrequency (RF) energy, giving physicians flexibility to tailor therapy. When combined with Abbott’s EnSite X EP system, the catheter uses the PFA Index (PI) to provide real-time feedback about lesion formation. Both energy modalities create therapeutic lesions that block abnormal electrical signals while minimizing effects on surrounding tissue.

Key findings from the FlexPulse IDE trial showed 92.6% of patients had no documented recurrence of atrial fibrillation (AFib), atrial flutter, or atrial tachycardia during follow-up based on standard-of-care monitoring. 77.4% had no documented recurrence under more rigorous protocol-driven monitoring.

The study met its primary effectiveness endpoint, with 74.6% of patients remaining free from documented arrhythmias, medication changes, or repeat procedures. The trial also reported a 98.3% patient safety rate, with no major safety events.

The IDE study aims to support TactiFlex Duo’s U.S. Food and Drug Administration (FDA) approval. It earned CE mark clearance earlier this year.

“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, MD, director of the Atrial Fibrillation Center and director of cardiac electrophysiology research at Cleveland Clinic, who presented the late-breaking FlexPulse IDE data at ESC. “The evidence behind this device helps increase confidence in ablation therapy and hopefully support lasting outcomes for patients with atrial fibrillation.”