The Food and Drug Administration approved Abbott’s TactiFlex Duo Ablation Catheter, Sensor Enabled, a device that combines pulsed-field ablation and radiofrequency energy in a single catheter to treat complex atrial fibrillation, according to a company announcement dated September 8, 2026.
Atrial fibrillation, or AFib, is an irregular heart rhythm that increases the risk of stroke and other complications. According to Abbott’s release, roughly 10.5 million people in the United States live with a heart that beats too fast, too slow, or in an irregular way. The condition is typically treated with medication, cardioversion, or catheter ablation, in which a physician uses energy delivered through a catheter to interrupt the abnormal electrical signals in the heart.
According to the company’s announcement, TactiFlex Duo lets physicians deliver pulsed-field ablation, radiofrequency energy, or a combination of both during a single procedure — an approach the company says allows treatment to be tailored to the patient. The device is paired with Abbott’s EnSite X EP System, which provides real-time mapping and integrates the PFA Index, a tool designed to assess lesion formation during ablation with TactiFlex Duo.
Regulatory approval was based on results from the FlexPulse IDE study. According to Abbott’s release, late-breaking data from the study were presented at the European Society of Cardiology Congress 2026 and simultaneously published in EP Europace, and the data showed favorable safety and effectiveness outcomes in patients with paroxysmal atrial fibrillation — a form of the condition in which irregular episodes come and go rather than being persistent.
The approval is Abbott’s fifth major electrophysiology approval in just over a year, following CE Mark approvals in Europe for Amulet 360 and TactiFlex Duo earlier in 2026 and U.S. and European approvals of the company’s Volt pulsed-field ablation system in 2025, according to the company’s release.
