Abbott Gains FDA Approval for Dual-Energy Ablation Catheter

Abbott has earned U.S. Food and Drug Administration (FDA) approval for the TactiFlex Duo Ablation Catheter, Sensor Enabled to treat patients with challenging cases of atrial fibrillation (AFib).

TactiFlex Duo is Abbott’s latest ablation catheter, giving physicians the flexibility to use pulsed field ablation (PFA), radiofrequency (RF) energy, or both during AFib procedures. Integrated with the company’s EnSite X EP system, the catheter also uses the PFA Index (PI) to provide real-time feedback on lesion formation.

The dual-energy approach is designed to create precise therapeutic lesions that disrupt abnormal electrical signals while minimizing effects on surrounding healthy tissue, helping restore normal heart rhythm and improve outcomes for patients with AFib.

FDA approval of TactiFlex Duo was supported by results from Abbott’s FlexPulse IDE study. Late-breaking data presented at the 2026 European Society of Cardiology Congress and published simultaneously in EP Europace showed favorable safety and effectiveness outcomes in patients with paroxysmal AFib.

The company will soon begin cases with broader commercial adoption across the country in the coming weeks.

Comments from Abbott and clinicians

Uri Yaron, Senior VP of Abbott’s electrophysiology business: “TactiFlex Duo represents an important advancement as Abbott builds the industry’s most comprehensive electrophysiology portfolio. From diagnosis, mapping and intracardiac ultrasound imaging to advanced treatments for the most complex arrhythmias, Abbott is uniquely positioned to support physicians at every stage of patient care. By continuing to expand our PFA portfolio and integrate innovative technologies across cardiovascular care, we’re helping physicians navigate increasingly complex procedures while ensuring more patients receive the right care at the right time.”

Atul Verma, MD, Director of Cardiology at the McGill University Health Centre in Montreal, Canada: “Electrophysiology is rapidly evolving as physicians adopt new technologies that improve the safety and effectiveness of AFib treatment. TactiFlex Duo provides physicians with greater flexibility during procedures, and when it is combined with the high-resolution 3D visualization available through Abbott’s EnSite X mapping system, physicians have a suite of practice-changing tools to confidently treat patients with complex AFib.”