Abbott's UltiSynq Defibrillation Lead Wins FDA Approval and CE Mark: One Lead for Both Pacing and Defibrillation
Abbott announced on November 10 in Abbott Park, Illinois, that its UltiSynq defibrillation lead has received U.S. Food and Drug Administration (FDA) approval and a European CE Mark. Implanted in the heart's left bundle branch area, the lead is designed to deliver both conduction system pacing and defibrillation therapy through a single lead, giving patients who are candidates for both pacing and defibrillation protection an additional option.
The lead is intended for long-term attachment to compatible implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) systems in patients at risk of sudden cardiac death due to life-threatening tachyarrhythmias. It had previously been designated an FDA breakthrough device, a program that expedites development and prioritizes review of devices with the potential to more effectively treat life-threatening or irreversibly debilitating conditions.
The approvals were supported by the ASCEND CSP IDE trial, a prospective, multicenter, global study evaluating the safety and effectiveness of the UltiSynq lead in patients indicated for ICD or CRT-D therapy, registered as NCT06830746. Three-month results presented as late-breaking data at the Heart Rhythm Society annual meeting in April 2026 showed the lead exceeded all pre-specified primary safety and effectiveness endpoints: implantation succeeded in 98.5% of the 205 patients, 86% achieved true or likely left bundle branch pacing, the major complication-free rate was 97.5%, and no lead-related major safety events were reported.
Abbott said left bundle branch area pacing is a conduction system pacing approach that works with the heart's natural electrical system to help restore a more coordinated heartbeat. With the simultaneous U.S. and European approvals, clinicians in both regions gain an additional approved lead option for patients who need both pacing and defibrillation.
(Source: Abbott)
Source: Abbott
Published by GSM · USA (original Chinese edition)
Photo: Wikimedia Commons（n28ive1 摄，CC BY）：植入式心律转复除颤器（ICD）实物资料图，非本次获批的 UltiSynq 导线本体
