Abbott’s UltiSynq defibrillation lead for treating irregular heart rhythms has simultaneously secured market approval in the US and Europe.
The US Food and Drug Administration (FDA) approval and European CE mark will mean the two regions will have an additional lead option for patients who are candidates for both conduction system pacing and defibrillation protection.
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Combining conduction system pacing (CSP) with defibrillation therapy in a single implantable wire, UltiSynq’s approvals were supported by results from Abbott’s ASCEND CSP (NCT06830746) investigational device exemption (IDE) trial evaluating its safety in patients indicated for implantable cardioverter defibrillator (ICD) or cardiac resynchronisation therapy defibrillator (CRT-D) therapy.
Abbott presented data from the ASCEND CSP as late-breaking data at the 2026 Heart Rhythm Society annual meeting, held in Chicago in April.
At three-months, the major complication-free rate for the 205 patients fitted with UltiSynq was 97.5%, meeting the trial’s primary endpoint. Meanwhile, lead implantation succeeded in 98.5% of patients. Among these, 86% achieved left bundle branch pacing (LBBP) or likely LBBP, indicating that UltiSynq stimulated or likely stimulated the heart’s natural conduction pathway.
Used alongside Abbott’s implantable cardioverter-defibrillators in patients who are at risk of sudden cardiac death due to tachyarrhythmias, UltiSynq is positioned as a lead option for patients requiring defibrillation protection who are suitable for CSP.
Patients with complex anatomy or high pacing thresholds could make them unsuitable for CSP, while those with normal native electrical conduction who do not need a pacemaker or CRT do not need CSP.
“UltiSynq represents an important advance as Abbott continues to build a comprehensive cardiac rhythm management portfolio,” said Randel Woodgrift, senior vice president of Abbott’s cardiac rhythm management business.
“Physicians now have a compelling option for conduction system pacing in patients who also need ICD or CRT-D therapy. UltiSynq extends physiologic pacing to patients who require both rhythm management and defibrillation protection,” Woodgrift continued.
In contrast to adjacent systems used for regulating heart rhythms, such as conventional pacemakers, which non-selectively stimulate the heart from the right ventricular wall, CSP directly targets the heart’s natural electrical pathways, simultaneously regulating heart rate and heartbeat coordination.
Abbott’s UltiSynq approvals in the US and Europe follow Medtronic’s receipt of a European CE mark for its next-generation portfolio of Vitalis pacemakers in October. Each of the five approved pacemakers within the portfolio includes advanced features purpose-built for CSP therapy.
