Abbott announced on April 25 new late-breaking clinical trial results at the Heart Rhythm Society 2026 meeting in Chicago, highlighting advances in its pulsed field ablation and conduction system pacing portfolios for treating abnormal heart rhythms.
The announcement is significant as it showcases recent progress in developing safer and more effective treatments for complex atrial fibrillation (AFib) and other heart rhythm disorders. These conditions affect millions of people worldwide, making innovations in this area important for both patients and healthcare providers.
Among the findings, six-month results from the FlexPulse IDE study demonstrated that Abbott’s TactiFlex Duo Ablation Catheter, Sensor Enabled, led to positive outcomes in treating complex AFib cases. The study found that most patients remained free from documented arrhythmias, with a high safety profile and a majority treated successfully using pulsed field ablation alone. “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 Jonathan P. Piccini, M.D., professor of medicine at Duke University Medical Center. “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.” The FlexPulse IDE study aims to secure U.S. Food and Drug Administration approval for this device.
Additional trials presented included results from Abbott’s ASCEND CSP IDE trial evaluating its investigational UltiSynq CSP implantable cardioverter-defibrillator lead designed for left bundle branch pacing (LBBP). Early data showed high safety rates with no major lead-related events reported. “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 Rahul N. Doshi, M.D., 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.” Abbott also reported initial success from its first-in-human evaluation of the AVEIR CSP leadless pacemaker system.
Further findings came from six-month data on Abbott’s Volt CE Mark Extension Cohort trial assessing posterior wall ablation using its Volt PFA System. Results indicated efficient procedures due to device design features and no patient or procedure-related complications were reported.
Priya Jagasia, divisional vice president at Abbott, said: “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… The data from these clinical trials serve as a cornerstone for the new innovations we’re developing to help people live healthier lives.”
