Abbott announces clinical results of pulsed field ablation for atrial fibrillation... Next-generation pacemakers and defibrillators also make progress

Abbott($ABT) announced new clinical data related to arrhythmia treatment technologies at the “2026 Heart Rhythm Society” in Chicago, USA. The release drew attention for confirming the safety and efficacy of the “Pulsed Field Ablation” technology used for atrial fibrillation(AFib) treatment and the entire next-generation pacemaker portfolio.

The data comprised a total of four late-stage clinical releases. Central to these were six-month results for the “TactiFlex Duo Ablation Catheter” targeting complex atrial fibrillation patients, data on the “Volt PFA System” extended to posterior wall ablation of the heart, and studies on implantable defibrillators/wireless pacemakers using conduction system pacing. Abbott is strengthening its “Integrated Portfolio” strategy, which aims to treat various arrhythmias based on patient condition rather than a single approach.

TactiFlex Duo achieves six-month results in complex atrial fibrillation treatment

Most notably, the “FlexPulse IDE” study results. In this clinical trial involving 188 patients, Abbott’s TactiFlex Duo Ablation Catheter showed that at six months, 87% of patients had no recorded arrhythmia recurrence. The proportion with no major safety events was 98.3%.

This device supports both radiofrequency(RF) and pulsed field ablation(PFA) energy modes simultaneously. RF ablates problematic tissue through heat, while PFA uses strong electrical pulses to selectively destroy cells causing abnormal rhythms. The advantage is that physicians can adjust the approach based on patient anatomy or disease complexity.

In fact, in this study, 93.3% of patients were treated with PFA alone, and 93.9% of patients did not require additional ablation after the initial procedure. Jonathan Piccini from Duke University Medical Center explained at the release event that TactiFlex Duo offers flexibility for personalized procedures, and the “point-to-point” PFA approach also demonstrated effectiveness in many patients.

Clinical trials for TactiFlex Duo seeking FDA approval are ongoing, and CE certification was obtained in Europe this year.

Volt PFA confirms safety in posterior wall ablation

Abbott also provided additional clinical evidence for the Volt PFA System through the “Volt CE Mark Extension Cohort” trial. The data focused on patients who, in addition to standard treatment, received ablation of the posterior wall of the left atrium. Since atrial fibrillation can originate not only around the pulmonary veins but also from abnormal signals in the posterior wall, the safety and efficacy of posterior wall ablation are important practical considerations.

According to the release, the medical team highlighted the ease of use and intuitive design of the Volt system as advantages. The average number of applications was 4.1 per vein, with 10.7 applications for posterior wall isolation(PWI). Abbott explained that this indicates a more efficient surgical process compared to existing commercial PFA devices. No complications related to patients or procedures were reported.

The Volt PFA System received FDA approval and CE marking last year. In recent years, PFA has gained attention in the arrhythmia treatment market as a technology that reduces thermal injury and shortens procedure times, so these results are seen as positive for Abbott’s competitive expansion.

Early clinical results for next-generation conduction system pacing devices also show promise

Abbott also announced preliminary results for two investigational conduction system pacing(CSP) devices. CSP is a pacing approach that more closely mimics the heart’s natural electrical conduction pathway, potentially achieving more physiological cardiac activation than traditional right ventricular apical pacing.

First, in the “ASCEND CSP IDE” trial, the “AltiSync CSP” implantable cardioverter defibrillator(ICD) lead met primary safety and efficacy endpoints based on three-month data. It demonstrated a 97.5% high safety profile, with no major safety issues related to the lead, and 99% of cases met the pacing standards for the left bundle branch area. Even under stricter criteria, success reached 86%.

Defibrillation performance was also notable. All patients had a 100% success rate with defibrillation, with 92.5% achieving success with a single 20-joule(J) shock. No inappropriate therapies due to misperception were reported. Rahul Doshi from Arizona State University commented that left bundle branch pacing is associated with more physiological activation, suggesting potential for extending this advantage to implantable defibrillators.

The wireless pacemaker “AVEIR CSP” also underwent initial human evaluation

Abbott’s development of the “AVEIR CSP” wireless pacemaker system has also released initial human study results. The preliminary one-month data from 19 patients showed high implantation success, stable electrical performance, and consistent device-to-device communication following the heart’s natural conduction pathway.

This is an early signal that battery-powered wireless pacemaker technology could expand into more refined conduction system pacing in the future. Although still in early research stages, market interest is expected to grow regarding its potential to reduce lead-related complications while maintaining natural rhythm regulation.

Arrhythmia treatment market competition and technological diversification are key

This release indicates that Abbott is expanding its arrhythmia treatment ecosystem beyond single devices to include ablation catheters, balloon PFA, implantable defibrillators, and wireless pacemakers. Especially for complex arrhythmias like atrial fibrillation, individual patient anatomy and disease presentation vary, making “one-size-fits-all” solutions increasingly inadequate.

Abbott Vice President Priya Jagasia stated that arrhythmia treatment is not a one-size-fits-all approach, and building a portfolio of cardiovascular products that covers various rhythm disorders is crucial. These clinical results are expected to serve as important evidence for Abbott’s continued product development and commercial expansion.

Although some devices are still only approved for research use in the U.S., these clinical data demonstrate Abbott’s growing influence in the rapidly expanding arrhythmia market. In particular, “Pulsed Field Ablation” and “Conduction System Pacing” are viewed as the next-generation core directions that will shape future standards in arrhythmia therapy.

TP AI note: This article was summarized using TokenPost.ai’s base language model. Main content may be omitted or factually inconsistent.