FDA approved Abbott's TactiFlex Duo dual-energy catheter for AFib ablation

Patients with challenging cases of atrial fibrillation (AFib) have a new treatment option now that the FDA has approved Abbott's TactiFlex Duo Ablation Catheter, Sensor Enabled, the company announced yesterday in a news release. Abbott said it plans to begin broader commercial use of the device across the country in the coming weeks.

AFib affects about 10.5 million people in the U.S. and raises the risk of stroke and other complications. Many patients manage the condition with medication, but others need catheter ablation, a minimally invasive procedure that targets the heart tissue producing abnormal electrical signals.

TactiFlex Duo is Abbott's newest ablation catheter and the latest addition to its electrophysiology lineup. It lets physicians switch between pulsed field ablation (PFA), radiofrequency (RF) energy or a combination of both during the same procedure, based on the anatomy and needs of each patient. The catheter works with Abbott's EnSite X EP System, a mapping platform that gives physicians real-time visualization during the procedure. The system also includes the PFA Index, a tool meant to help operators assess how well a lesion is forming as they ablate.

"Electrophysiology is rapidly evolving as physicians adopt new technologies that improve the safety and effectiveness of AFib treatment," Atul Verma, M.D., director of cardiology at the McGill University Health Centre in Montreal, said in the news release. "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."

The approval is supported by 12-month results from Abbott's FlexPulse study, a clinical trial that enrolled 180 patients with symptomatic, drug-refractory paroxysmal AFib at 24 sites in the U.S. and Europe. The data were presented as a late-breaking trial at the European Society of Cardiology (ESC) Congress 2026 and published simultaneously in the journal EP Europace.

Pulmonary vein isolation, the core procedure used to block the electrical signals that trigger AFib, succeeded in all 180 patients. The study's primary safety event rate was 1.7%, with four events reported in three patients and no strokes, deaths or esophageal injuries. At 12 months, 74.6% of patients were free from a primary effectiveness failure, a composite measure that included arrhythmia recurrence, repeat procedures and new or escalated antiarrhythmic drug use. Freedom from documented arrhythmia recurrence was 77.4%, or 92.6% when measured using standard-of-care monitoring rather than the trial's more frequent transtelephonic checks.

Patients also reported gains in quality of life. Scores on the AF Effect on Quality-of-Life survey rose an average of 31.6 points from baseline to 12 months, an increase researchers called clinically meaningful.

"These results confirm the safety and efficacy of a dual-energy focal ablation system with both RF and PF capabilities," the study's authors wrote in the paper's conclusion.

The FlexPulse results are broadly in line with other recent AFib ablation trials, though cross-study comparisons are limited by differences in monitoring protocols and patient populations. Freedom from recurrence using standard-of-care monitoring reached 92.6% with TactiFlex Duo, compared with 84.2% in the SmartfIRE trial of a different dual-energy catheter and 90.5% in the VARIPURE registry for a pulsed-field-only device, according to the study. Single-shot PFA catheters such as FaraPulse and Varipulse have posted freedom-from-recurrence rates in earlier trials ranging from roughly 75% to 83%.

Abbott is positioning TactiFlex Duo as part of a broader push into electrophysiology, an area where device makers are racing to expand PFA offerings following the technology's rapid adoption.

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