Abbott announced on April 25 new late-breaking results from four clinical trials showing positive outcomes for its pulsed field ablation and conduction system pacing technologies to treat abnormal heart rhythms.
These findings are important as they highlight advances in the treatment of complex atrial fibrillation and other heart rhythm disorders, which can have serious health impacts. The company shared six-month results from the FlexPulse IDE study using the TactiFlex Duo Ablation Catheter, Sensor Enabled, as well as new evidence for posterior wall ablation with the Volt PFA System. Data were also presented for Abbott’s ASCEND CSP IDE trial of the investigational UltiSynq CSP implantable cardioverter-defibrillator lead and a first-in-human evaluation of the AVEIR CSP leadless pacemaker system.
Jonathan P. Piccini, M.D., professor of medicine at Duke University Medical Center, said, “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. 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 after it received CE Mark in Europe earlier this year.
In addition to these results, Rahul N. Doshi, M.D., FHRS, FACC, professor of medicine at Arizona State University said about another trial: “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. 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 benefits of physiologic pacing to ICD patients in an efficient manner.” Abbott also reported high implantation success rates in its first-in-human AVEIR CSP leadless pacemaker study.
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 new innovations we’re developing to help people live healthier lives.” Late-breaking six-month data from another trial showed positive outcomes when treating additional areas within standard procedures using Volt PFA System technology.
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