Abbott’s Dual-Energy Ablation Catheter Cleared by FDA for Complex AFib

Abbott said on September 8, 2026, that the U.S. Food and Drug Administration has approved its TactiFlex Duo Ablation Catheter, Sensor Enabled, for treating patients with challenging cases of atrial fibrillation, clearing a device that combines pulsed field ablation and radiofrequency energy in a single catheter. The company’s announcement stated that Abbott will soon begin cases, with broader commercial adoption across the country expected in the coming weeks.

Atrial fibrillation is an irregular heart rhythm that raises the risk of serious complications, including stroke. According to the announcement, 10.5 million people in the U.S. live with a heart that beats too fast, too slow, or in an irregular way. While many patients are treated with medications, others require cardiac ablation, a minimally invasive procedure that targets the tissue responsible for abnormal electrical signals in the heart.

A Dual-Energy Approach to AFib Ablation

TactiFlex Duo is designed to let physicians use pulsed field ablation (PFA), radiofrequency (RF) energy, or a combination of both during a single procedure, allowing treatment to be tailored to each patient’s needs. Both energy types create therapeutic lesions, small areas of scar tissue that block the abnormal electrical signals causing an irregular heartbeat while helping minimize the impact on surrounding healthy tissue. Abbott said successfully treating these areas can help restore the heart’s normal rhythm.

The catheter is integrated with Abbott’s EnSite X EP System, a mapping system that creates three-dimensional maps of the heart. The system provides real-time feedback through a tool called the PFA Index, which is designed to assess lesion formation during ablation with TactiFlex Duo. The device also works alongside Abbott’s Advisor HD Grid X mapping catheter and the ViewFlex X ICE intracardiac echocardiography catheter with the EnSite Echo Module, an integrated portfolio Abbott says is designed to give physicians real-time images of the ablation catheter’s positioning and movement, along with a digital model of the patient’s heart throughout a procedure.

According to the announcement, patients with atrial fibrillation, particularly those with complex anatomy, prior or failed ablations, or other challenging clinical situations, may benefit from treatment with TactiFlex Duo as determined by their physician.

FlexPulse IDE Study Underpins the Approval

The FDA approval was secured on the basis of results from Abbott’s FlexPulse Global IDE study. Twelve-month data from the study were presented in a late-breaking session at the European Society of Cardiology Congress in Munich, Germany, on August 29, 2026, and simultaneously published in EP Europace, according to a separate Abbott announcement dated August 31, 2026.

The study met its primary effectiveness endpoint, with 74.6% of patients remaining free from documented arrhythmias, medication changes, or repeat procedures, the company reported. Among the key findings, 92.6% of patients had no documented recurrence of AFib, atrial flutter, or atrial tachycardia during follow-up when assessed using standard-of-care monitoring. Under protocol-driven monitoring, which follows more rigorous heart rhythm assessments throughout the study, 77.4% of patients experienced no documented recurrence. Abbott reported a patient safety profile of 98.3% with no major safety events. The outcomes were recorded in patients with paroxysmal atrial fibrillation, in which irregular heart rhythm episodes come and go.

“As physicians, we’re looking for technologies that help us confidently deliver the best possible outcomes for our patients, not just at the time of the procedure, but for years afterward,” said Ayman Hussein, M.D., Director of the Atrial Fibrillation Center and Director of Cardiac Electrophysiology Research at Cleveland Clinic, who presented the late-breaking FlexPulse IDE data at the congress.

Atul Verma, M.D., Director of Cardiology at the McGill University Health Centre in Montreal, Canada, said in the approval announcement that electrophysiology is rapidly evolving as physicians adopt new technologies. “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,” he said.

Fifth Electrophysiology Approval in Just Over a Year

The TactiFlex Duo clearance is Abbott’s fifth major electrophysiology approval in just over a year, according to the company. It follows CE Mark approvals in Europe this year for the Amulet 360 Left Atrial Appendage Occluder and for TactiFlex Duo itself, as well as U.S. and European approvals of the Volt PFA System in 2025. Abbott noted that the Amulet 360 is approved for investigational use only in the U.S.

“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. He said the company is continuing to expand its PFA portfolio and integrate technologies across cardiovascular care, spanning diagnosis, mapping, intracardiac ultrasound imaging, and treatments for complex arrhythmias.

The U.S. approval makes the dual-energy catheter the latest generation of Abbott’s cardiac ablation technology available to American physicians. The company said clinical data has shown the technology to be safe and effective, with the catheter offering physicians procedural flexibility and precision through its dual-energy capabilities while reducing the potential for damage to surrounding tissue.