FDA Approves Duo Ablation Catheter

Sept. 8, 2026 — Abbot has announced that it has received U.S. Food and Drug Administration (FDA) approval for the TactiFlex Duo Ablation Catheter, Sensor Enabled to treat patients with challenging cases of atrial fibrillation (AFib).

Cardiac Ablation for People with AFib

For the 10.5 million people in the U.S. who live with a heart that beats too fast, too slow or in an irregular way, treatment is critical as AFib increases the risk of serious complications, including stroke.^1,2 While many people are treated with medications, others require cardiac ablation, a minimally invasive procedure that targets the tissue responsible for abnormal electrical signals in the heart.

TactiFlex Duo ablation catheter is designed to give physicians more flexibility when treating AFib. The technology allows physicians to use pulsed field ablation (PFA), radiofrequency (RF) energy or a combination of both during a procedure, helping them tailor treatment to each patient's needs. Abbott's EnSite X EP System also provides physicians with real-time feedback as an integrated mapping solution with the PFA Index (PI), a tool designed to assess lesion formation during ablation with TactiFlex Duo. The dual-energy approach means physicians can create precise therapeutic lesions, or small areas of scar tissue, that block the abnormal electrical signals causing an irregular heartbeat while helping minimize the impact on surrounding healthy tissue. Successfully treating these areas can help restore the heart's normal rhythm and improve outcomes for patients living with AFib. 

"Electrophysiology is rapidly evolving as physicians adopt new technologies that improve the safety and effectiveness of AFib treatment," said Atul Verma, M.D., Director of Cardiology at the McGill University Health Centre in Montreal, Canada, and a globally recognized expert in pulsed field ablation technology. "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."

Safety and Effectiveness Data 

The FDA approval of TactiFlex Duo was secured based on the results from Abbott's FlexPulse IDE study. Late-breaking data from the study recently presented at the European Society of Cardiology (ESC) Congress 2026, which was simultaneously published in EP Europace, showed favorable safety and effectiveness outcomes in patients with paroxysmal AFib (irregular heart rhythm episodes that come and go).

"TactiFlex Duo represents an important advancement as Abbott builds the industry's most comprehensive electrophysiology portfolio," said Uri Yaron, senior vice president of Abbott's electrophysiology business. "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."

References

1. Noubiap JJ, Tang JJ, Teraoka JT, Dewland TA, Marcus GM. Minimum National Prevalence of Diagnosed Atrial Fibrillation Inferred From California Acute Care Facilities. J Am Coll Cardiol. 2024;84(16):1501-1508. doi:10.1016/j.jacc.2024.07.014.

2. About Atrial Fibrillation. Centers for Disease Control. (n.d.). About Atrial Fibrillation | Heart Disease | CDC.

3. Friedman, et al. (2025 September) Development of a PFA index to guide energy delivery with a force sensing flexible, irrigated tip catheter [Oral presentation]. ESC 2025, Madrid, Spain.