Abbott Showcases Technologies to Address Abnormal Heart Rhythms with Late-Breaking Clinical Data

Published: 2026-04-25 15:20:24 ET ABT

Published on 04/25/2026 at 03:20 pm EDT

Abbott announced new late-breaking data from four trials that demonstrate strong clinical outcomes within its pulsed field ablation (PFA) and conduction system pacing (CSP) portfolios to treat heart rhythm disorders. The data include six-month results from the FlexPulse IDE study, which examines treating complex atrial fibrillation (AFib) cases with the TactiFlex Duo Ablation Catheter, Sensor Enabled as well as new clinical evidence for posterior wall ablation with the Volt PFA System. Data were also presented for Abbott's ASCEND CSP IDE trial for the company's investigational UltiSynq CSP implantable cardioverter-defibrillator (ICD) lead, as well as a first-in-human evaluation of the LEAP2 chronic early feasibility trial for the investigational AVEIR CSP leadless pacemaker system.

New six-month data from the FlexPulse IDE study provide early insights showing positive patient outcomes with Abbott's TactiFlex Duo Ablation Catheter, Sensor Enabled, and confirms the strong safety and efficacy profile seen in the CE Mark study for treating complex AFib cases. The catheter provides physicians with two energy modes to tailor therapy based on a patient's complex disease or anatomy: radiofrequency ? which uses heat energy that destroys tissue responsible for erratic heart signals ?

and PFA, which uses high energy electrical pulses that destroy the cells causing abnormal heart rhythms. The late-breaking six-month data for the 188-patient FlexPulse IDE study show: The majority (87%) of patients reported being free from documented arrhythmias. A high safety profile (98.3%) with no major safety events. The majority (93.3%) of patients were treated exclusively with PFA, demonstrating that this energy source alone was successful in treating complex cases.

Physicians efficiently treated their patients ? 93.9% did not require an additional ablation after the first round of therapy. The FlexPulse IDE study was designed to secure U.S. Food and Drug Administration (FDA) approval for the TactiFlex Duo.

The catheter received CE Mark in Europe earlier this year. Results from two late-breaking clinical trials evaluated Abbott's investigational leadless and traditional pacing/defibrillation CSP technologies designed to deliver left bundle branch pacing (LBBP), an approach intended to more closely replicate the heart's natural electrical activation. Both data presentations were simultaneously published in Heart Rhythm.

The ASCEND CSP IDE trial evaluated the investigational high-voltage UltiSynq CSP ICD lead designed to be implanted in the left bundle branch (LBB) area or the right ventricle to deliver both pacing and defibrillation. The three-month data show UltiSynq CSP successfully met the study's pre-specified primary safety and effectiveness endpoints. Key findings included: A high safety profile (97.5%) with no lead-related major safety events reported.

A high success rate (99%) meeting left bundle branch area pacing (LBBAP) criteria which can be compared to results from previously reported trial(s). An 86% success rate was met using the more stringent LBBP or likely LBBP criteria. An average of fewer than one (0.9) repositioning attempt per patient was also achieved.

100% defibrillation success, with the majority (92.5%) achieving first shock success at 20J. No patients required repositioning of the ICD lead to achieve effective defibrillation. Stable electrical performance at three months, with no inappropriate therapies delivered due to P-wave or T-wave oversensing.

Abbott also presented late-breaking results from a first-in-human clinical study evaluating Abbott's investigational AVEIR CSP leadless pacemaker system. The one-month data from the 19-patient study found a high implantation success rate along with: Delivery of pacing that closely followed the heart's natural electrical pathways. Reliable electrical performance and functioning at the time of implant and through the first month of follow-up.

Consistent communication between devices in a dual-chamber pacemaker setting. Late-breaking six-month data from the Volt CE Mark Extension Cohort trial demonstrated positive outcomes for patients in which the posterior wall of the heart was treated in addition to the standard treatment. New data from the Volt CE Mark Extension Cohort trial show: Physicians cited the device's ease of use and intuitive design as contributors to efficiently treat their patients with fewer therapy applications (4.1 applications per vein and 10.7 per PWI on average) compared to other on-market PFA systems. A high safety profile with no reported patient or procedure-related complications.

The Volt PFA System secured FDA approval and CE Mark in Europe last year. TactiFlex Duo Ablation Catheter, Sensor Enabled, AVEIR CSP Leadless Pacemaker System, and UltiSynq CSP are approved for investigational use only in the U.S.