FDA Approves Abbott Dual-Energy Catheter for Complex AFib Cases

Atrial fibrillation is common in the United States and raises the risk of serious complications, including stroke. While many patients are managed with medication, others require minimally invasive catheter ablation to target tissue driving abnormal electrical signals. As electrophysiology teams manage complex cases, they need tools that adapt energy delivery to varied cardiac anatomy. A new dual-energy ablation catheter now combines pulsed field ablation and radiofrequency delivery in one device.

Abbott’s TactiFlex Duo Ablation Catheter, Sensor Enabled has received U.S. Food and Drug Administration (FDA) approval to treat patients with challenging cases of atrial fibrillation. The dual‑energy catheter is the latest generation in the company’s cardiac ablation portfolio and is designed to give physicians greater procedural precision and flexibility. Abbott noted it will begin cases with broader U.S. adoption in the coming weeks.

The technology allows electrophysiologists to deliver pulsed field ablation (PFA), radiofrequency (RF) energy, or a combination of both during a single procedure. The catheter integrates with the EnSite X electrophysiology (EP) mapping system, which provides real‑time feedback through a PFA Index designed to assess lesion formation during ablation with TactiFlex Duo. The dual‑energy approach is intended to create precise therapeutic lesions that block abnormal electrical signals while helping minimize impact on surrounding healthy tissue.

Regulatory clearance was supported by results from Abbott’s FlexPulse investigational device exemption (IDE) study. Late‑breaking data from this study were recently presented at the European Society of Cardiology Congress 2026 and were simultaneously published in EP Europace, reporting favorable safety and effectiveness outcomes in patients with paroxysmal atrial fibrillation. The company also cited strong clinical evidence demonstrating high rates of safety and effectiveness in treated patients.

The U.S. approval further expands a portfolio of technologies designed to help physicians treat patients with cardiac arrhythmias. It is the company’s fifth major electrophysiology approval in just over a year, following CE Mark approvals for Amulet 360 and TactiFlex Duo in Europe in 2026, and U.S. and European approvals of the Volt PFA System in 2025.

“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,” said Uri Yaron, senior vice president of Abbott’s electrophysiology business.