Abbott Receives FDA Approval and CE Mark for UltiSynq Defibrillation Lead

Abbott has received U.S. Food and Drug Administration (FDA) approval and CE Mark for the UltiSynq defibrillation lead, which is designed to deliver both conduction system pacing and defibrillation therapy, providing an additional lead option in the U.S. and EU for patients who are candidates for both conduction system pacing and defibrillation protection.

Approximately 150,000 implantable cardioverter-defibrillators (ICDs) are implanted in the United States and 140,000 in Europe each year, representing a significant patient population for whom pacing performance has meaningful long-term consequences. Left bundle branch area pacing (LBBAP) has emerged as a conduction system pacing approach aiming to restore the heart’s natural pattern of electrical activation. Designated as an FDA breakthrough device, the UltiSynq lead is a program that expedites development and prioritizes review of medical devices with the potential to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating conditions.

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