Abbott (NYSE: ABT) received U.S. Food and Drug Administration approval for the TactiFlex Duo Ablation Catheter, Sensor Enabled, a device that combines pulsed field ablation (PFA) and radiofrequency energy in a single catheter for treating irregular heart rhythms.
The approval allows physicians to use either energy type or both during procedures to target tissue responsible for abnormal electrical signals in patients with atrial fibrillation, a minimally invasive approach to managing the condition.
The device integrates with Abbott's EnSite X EP System, which creates three-dimensional heart maps, and uses a tool called PFA Index to provide real-time feedback for assessing lesion formation during procedures.
Clinical data supporting the approval came from the FlexPulse IDE study, presented at the European Society of Cardiology Congress 2026 and published in EP Europace. The study demonstrated safety and effectiveness outcomes in patients with paroxysmal atrial fibrillation.
"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," said Atul Verma, director of cardiology at the McGill University Health Centre in Montreal.
Abbott said it will begin cases with broader commercial adoption across the country in the coming weeks.
The FDA approval marks Abbott's fifth major electrophysiology approval in just over a year. Previous milestones include European approvals of the Amulet 360 and TactiFlex Duo in 2026, and U.S. and European approvals of the Volt PFA System in 2025.
Atrial fibrillation affects approximately 10.5 million people in the U.S. and increases the risk of complications including stroke, according to the Centers for Disease Control and Prevention.
