At Heart Rhythm Society (HRS) 2026 in Chicago, the company shared data from four trials backing the portfolios. Findings included six-month data from the FlexPulse IDE study evaluating the TactiFlex Duo ablation catheter, Sensor Enabled (SE), along with new clinical evidence for posterior wall ablation with the Volt PFA system.
The company also shared findings from the ASCEND CSP IDE trial evaluating its investigational UltiSynq CSP implantable cardioverter-defibrillator (ICD) lead. Finally, it revealed a first-in-human evaluation of its Aveir CSP leadless pacemaker system. That data came from the LEAP2 chronic early feasibility trial.
“Treating abnormal heart rhythms is not a siloed or one-size-fits-all approach, which is why Abbott is creating a holistic cardiovascular portfolio that empowers physicians to care for a wide range of arrhythmias,” said Priya Jagasia, divisional vice president of regulatory, clinical, reimbursement and strategic initiatives at Abbott. “The data from these clinical trials serve as a cornerstone for the new innovations we’re developing to help people live healthier lives.“
The data for the Abbott TactiFlex Duo SE
New six-month data from the FlexPulse IDE study demonstrated positive patient outcomes with the TactiFlex Duo system. Abbott said findings confirmed the strong safety and efficacy profile seen in its FOCALFLEX CE mark study for treating complex AFib cases.
TactiFlex Duo, a dual-energy, focal ablation catheter, enables physicians to tailor how they deliver AFib therapy. Its radiofrequency energy capabilities use heat to destroy tissue responsible for erratic heart signals. The pulsed field function uses high-energy electrical pulses to destroy the cells causing abnormal heart rhythms. The CE-marked catheter has FDA breakthrough device designation for the treatment of ventricular tachycardia (VT). It could rival J&J MedTech’s ThermoCool dual-ablation catheter.
Abbott said its latest findings come from 188 patients, with the majority (87%) reporting freedom from documented arrhythmias. The study also observed a high safety profile (98.3%) with no major safety events.
Investigators reported that the majority (93.3%) of patients underwent exclusively PFA treatment, with effective treatments demonstrated as 93.9% of patients did not require an additional ablation after their first round of therapy.
“The Abbott TactiFlex Duo catheter offers the convenience of seamlessly switching treatment between radiofrequency and pulsed field ablation based upon the patient’s anatomy and their personalized ablation plan,” said Dr. Jonathan Piccini, professor of medicine, Duke University Medical Center, who presented the late-breaking data at HRS. “While RF has long been a well-established ablation approach, with this study, we have been able to show that the TactiFlex Duo’s point-to-point PFA is an effective approach for a significant number of our patients.”
Volt also shows further promise
The FDA-approved and CE-marked Volt competes in the hot PFA space against the likes of Farapulse (Boston Scientific), PulseSelect (Medtronic), Varipulse (Johnson & Johnson), and Globe (Kardium), among others.
Volt provides a single-catheter PFA approach to improve workflow and provide procedural flexibility. The company designed Volt to address the limitations of existing PFA technologies.
Late-breaking six-month data from the company’s CE mark extension cohort demonstrated positive outcomes in posterior wall ablation. The extension evaluated the treatment of that region of the heart in addition to standard treatment.
According to Abbott, physicians cited the device’s ease of use and intuitive design as contributors to the effective treatment of their patients with fewer therapy applications compared to other on-market PFA systems. The company said physicians averaged 4.1 applications per vein and 10.7 applications per posterior wall isolation (PWI).
Volt also delivered a high safety profile, with no reported patient- or procedure-related complications.
First outcomes from investigational Abbott CSP devices product optimism
Two late-breaking trials evaluated Abbott’s investigational leadless and traditional pacing/defibrillation CSP technologies designed to deliver left bundle branch pacing (LBBP). This approach aims to more closely replicate the heart’s natural electrical activation.
Abbott and Medtronic both delivered positive trial outcomes for LBBAP systems last year, with Biotrink recently winning FDA approval for the therapy as well.
The ASCEND CSP IDE study evaluated the investigational, high-voltage UltiSynq CSP ICD lead. Abbott designed it for implantation in the LBB area or the right ventricle to deliver both pacing and defibrillation.
Three-month data showed that the system successfully met the study’s pre-specified primary safety and effectiveness endpoints. It delivered a high safety profile (97.5%) with no lead-related major safety events reported. UltiSynq’s success rate (99%) met left bundle branch area pacing (LBBAP) criteria. It recorded an 86% success rate using more stringent LBBP or likely LBBP criteria.
Investigators reported an average of fewer than one (0.9) repositioning attempt per patient. Defibrillation success came in at 100%, with the majority (92.5%) achieving first shock success at 20J. No patients required ICD lead repositioning and electrical performance proved stable at three months. Investigators saw no inappropriate therapies delivered due to P-wave or T-wave oversensing.
“Physicians are increasingly using left bundle area pacing for pacemaker patients, because it is associated with improved physiological activation compared with traditional pacing on the right side of the heart,” said Dr. Rahul N. Doshi, professor of medicine at Arizona State University. “The data from the ASCEND trial show that an ICD lead designed for physiologic pacing can support restoration of normal heart rhythms when placed in the left bundle branch area. These early results suggest the potential to extend the benefits of physiologic pacing to ICD patients in an efficient manner.”
Additional findings support more pacing tech
Abbott also shared late-breaking results from a first-in-human clinical study evaluating its investigational Aveir CSP leadless pacemaker.
The company already offers Aveir DR, a dual-chamber pacemaker, for treating abnormal heart rhythms. The system delivers electrical impulses directly to the heart muscle, restoring the normal heart rhythm. Unlike traditional pacemakers, the leadless device goes directly into the heart through a minimally invasive, catheter-based procedure. This eliminates the need for cardiac leads and a pulse generator under the skin.
One-month data from a 19-patient study of Aveir CSP found a high implantation success rate. Additionally, investigators saw that delivery of pacing closely followed the heart’s natural electrical pathways.
Aveir CSP also delivered reliable electrical performance and functioning at the time of implant through the first month of follow-up. It also delivered consistent communication between devices in a dual-chamber pacemaker setting.
