Abbott’s TactiFlex Duo ablation catheter wins FDA approval for treating abnormal heart rhythms

Abbott has received FDA approval for its TactiFlex Duo Ablation Catheter, Sensor Enabled, a device designed to treat patients with complex cases of atrial fibrillation. The catheter combines pulsed field ablation and radiofrequency energy in a single tool, and the clearance marks a step forward in the company’s push to give physicians more precise and flexible options for managing difficult heart rhythm cases. Abbott plans to expand commercial availability of the device across the US in the coming weeks.

Roughly 10.5 million people in the US live with a heart that beats too fast, too slow or irregularly, and treatment matters because AFib raises the risk of serious complications, including stroke. While many patients manage the condition with medication, others need cardiac ablation, a minimally invasive procedure that targets the heart tissue responsible for abnormal electrical signals.

TactiFlex Duo lets physicians switch between pulsed field ablation and radiofrequency energy, or combine both, during a single procedure, depending on what a given patient’s anatomy and case require. Pulsed field ablation, a newer approach gaining traction in electrophysiology, uses high energy electrical pulses to target the cells driving abnormal rhythms, while radiofrequency, a longer established method, relies on heat. The device works alongside Abbott’s EnSite X EP System, a mapping platform that gives physicians real time feedback during the procedure and includes a tool for assessing lesion formation as ablation occurs.

The approval was supported by data from Abbott’s FlexPulse IDE study, which reported strong safety and effectiveness results in patients with paroxysmal AFib. That data was presented at the European Society of Cardiology Congress 2026 and published simultaneously in EP Europace.

This is Abbott’s fifth major electrophysiology approval in just over a year, as the company continues building out its position in the fast growing pulsed field ablation market, alongside earlier cardiac ablation approvals across the US, Europe, Asia and Latin America.

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