Abbott receives FDA approval and CE mark for UltiSynq conduction-system defibrillation lead

Abbott has secured US FDA approval and European CE marking for its UltiSynq defibrillation lead, combining conduction-system pacing capabilities with implantable defibrillator therapy.

Abbott announced on 10 November 2026 that the UltiSynq implantable cardioverter-defibrillator lead had received FDA approval and European CE marking, enabling left bundle branch area pacing alongside defibrillation therapy when used with compatible ICD or CRT-D systems.

In the supporting ASCEND CSP investigational device study, implantation succeeded in 98.5% of 205 attempts, 86% of successfully implanted patients achieved confirmed or likely left bundle branch pacing, and the major complication-free rate at three months was 97.5%, supporting the device's regulatory milestones in the United States and Europe.

Field	Content
Article Type	Approvals
Company	Abbott
Product	UltiSynq
Device Type	Implantable cardioverter-defibrillator lead
Announcement Date	10 November 2026
US Regulatory Authority	US Food and Drug Administration
US Regulatory Milestone	FDA approval
European Regulatory Milestone	CE marking
Regulatory Markets	United States and Europe
Device Application	Conduction-system pacing and defibrillation therapy
Pacing Approach	Left bundle branch area pacing
Pacing Abbreviation	LBBAP
Compatible System Types	Implantable cardioverter-defibrillator and cardiac resynchronisation therapy defibrillator systems
ICD Definition	Implantable cardioverter-defibrillator
CRT-D Definition	Cardiac resynchronisation therapy defibrillator
Therapeutic Area	Cardiac electrophysiology
Clinical Application	Cardiac rhythm management
Supporting Clinical Study	ASCEND CSP
Study Classification	Investigational Device Exemption study
Implantation Attempts	205
Implantation Success Rate	98.5%
Confirmed or Likely Left Bundle Branch Pacing	86% among successfully implanted patients
Major Complication-Free Rate	97.5%
Safety Follow-Up Period	Three months
Device Innovation	Integration of conduction-system pacing capability with defibrillation therapy
Drug Approval Involved	No
Regulatory Distinction	FDA approval and European CE marking are separate device regulatory milestones
What Happened	Abbott announced FDA approval and CE marking for its UltiSynq defibrillation lead.
Why It Matters	The device expands cardiac rhythm management options by supporting conduction-system pacing within compatible defibrillator systems.
Clinical Significance	The ASCEND CSP study reported high implantation success and a high major complication-free rate at three months.
Regulatory Significance	Establishes US and European regulatory milestones for the device.
Key Takeaway	UltiSynq has received FDA approval and CE marking following supportive investigational device study results.
What to Watch	Commercial availability, physician adoption, procedural experience, longer-term safety and clinical outcomes.
Primary Source	Abbott
Primary Source URL	https://abbott.mediaroom.com/press-releases?item=124791
Relevant Date	10 November 2026

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