Abbott Secures FDA Approval for Dual-Energy Heart Rhythm Device

This regulatory clearance marks a significant expansion of Abbott’s electrophysiology portfolio, which has seen five major approvals in just over a year. The TactiFlex Duo is designed to address the needs of the 10.5 million Americans living with atrial fibrillation, a condition that significantly elevates the risk of stroke. During procedures, the device works alongside the EnSite X EP System to provide real-time mapping and feedback, helping surgeons create precise scar tissue to block erratic electrical signals while sparing surrounding healthy heart tissue.

Clinical support for the device stems from the FlexPulse IDE study, with findings recently highlighted at the European Society of Cardiology Congress 2026. Experts suggest the technology’s primary advantage lies in its procedural flexibility. By offering two distinct energy modalities, the catheter enables doctors to navigate challenging anatomy and complex arrhythmias with greater confidence. Commercial implementation is scheduled to begin across the United States in the coming weeks, signaling a shift toward more tailored, minimally invasive cardiac care.