One-year follow-up results from the FlexPulse IDE study showed that Abbott’s TactiFlex Duo catheter was safe and effective in treating patients with atrial fibrillation, in a step the company plans to use as the basis for submitting an application to the U.S. Food and Drug Administration (FDA) to market the device in the United States.
The catheter combines pulsed-field ablation (PFA) and radiofrequency ablation (RF) technologies in a single device. Abbott says this design gives physicians greater flexibility in choosing and tailoring the treatment method to patients’ needs, particularly in complex cases of atrial fibrillation, a heart rhythm disorder that may be associated with stroke or heart failure.
What did the study show?
The FlexPulse IDE study included a total of 180 participants with paroxysmal atrial fibrillation. According to results announced by Abbott, pulmonary vein isolation was successfully achieved in all participants, a procedure intended to prevent abnormal electrical signals from triggering the arrhythmia.
The study also achieved its primary efficacy endpoint, with 74.6% of patients remaining free of documented arrhythmias, medication changes, or repeat therapeutic procedures during the one-year follow-up period. The rate of events related to the primary safety endpoint was 1.7%.
The one-year data were presented at the European Society of Cardiology conference and published in EP Europace. The results follow the presentation of six-month follow-up data from the study at the Heart Rhythm Society meeting in April.
Why does this development matter?
Abbott is positioning the catheter as part of its effort to expand its presence in the electrophysiology market, where it competes with companies including Boston Scientific, Medtronic, and Johnson & Johnson. Atrial fibrillation treatment is seeing growing interest in PFA systems that use electrical pulses, while conventional radiofrequency ablation relies on heat to create scar tissue that blocks abnormal signals.
The source notes that PFA may reduce the risk of injury to surrounding organs compared with thermal radiofrequency ablation, but the practical significance of TactiFlex Duo is not limited to using a single technology; combining PFA and RF allows the physician to switch between the two energies within the same catheter when designing the treatment plan.
What remains unresolved?
The current results do not mean that the device has received U.S. approval. TactiFlex Duo received the CE mark in Europe earlier in 2026, while Abbott is preparing to use the study data in its submission to the FDA. Therefore, the device’s availability in the United States remains subject to the regulator’s review and decision.
The data published here also focus on 180 patients with paroxysmal atrial fibrillation and do not, on their own, establish the catheter’s performance in all patient types or conditions. Abbott also sells the Volt pulsed-field ablation system, and CEO Robert Ford said that an updated version, called Volt 2.0, was launched in the United States in May.