WS Investor
10 Nov 2026, 16:28
Abbott Wins FDA Approval and CE Mark for UltiSynq Defibrillation Lead
Abbott (NYSE: ABT) received both U.S. FDA approval and CE Mark for UltiSynq, a new implantable cardioverter-defibrillator lead designed to deliver conduction system pacing and defibrillation therapy through the heart’s natural electrical pathway.
UltiSynq is designed for implantation in the left bundle branch area, allowing physicians to combine physiologic pacing with ICD or CRT-D protection in a single lead. The device previously received FDA Breakthrough Device designation.
Approval was supported by the ASCEND CSP IDE trial. Among 205 implant attempts, implantation was successful in 98.5% of patients, while 86% of successfully implanted patients achieved confirmed or likely left bundle branch pacing.
The study also reported a 97.5% major complication-free rate at three months. Among 120 patients who underwent defibrillation testing, successful defibrillation was achieved in 100% of cases without requiring lead repositioning.
Abbott said UltiSynq’s short shock coil and true bipolar sensing are designed to improve positioning precision and reduce susceptibility to P-wave oversensing, which can potentially trigger inappropriate therapy.
The approvals expand Abbott’s cardiac rhythm management portfolio and give physicians a new option for patients who require both defibrillation protection and conduction system pacing, an approach aimed at producing a more coordinated and physiologic heartbeat.
Abbott (NYSE: ABT) received both U.S. FDA approval and CE Mark for UltiSynq, a new implantable cardioverter-defibrillator lead designed to deliver conduction system pacing and defibrillation therapy through the heart’s natural electrical pathway.
UltiSynq is designed for implantation in the left bundle branch area, allowing physicians to combine physiologic pacing with ICD or CRT-D protection in a single lead. The device previously received FDA Breakthrough Device designation.
Approval was supported by the ASCEND CSP IDE trial. Among 205 implant attempts, implantation was successful in 98.5% of patients, while 86% of successfully implanted patients achieved confirmed or likely left bundle branch pacing.
The study also reported a 97.5% major complication-free rate at three months. Among 120 patients who underwent defibrillation testing, successful defibrillation was achieved in 100% of cases without requiring lead repositioning.
Abbott said UltiSynq’s short shock coil and true bipolar sensing are designed to improve positioning precision and reduce susceptibility to P-wave oversensing, which can potentially trigger inappropriate therapy.
The approvals expand Abbott’s cardiac rhythm management portfolio and give physicians a new option for patients who require both defibrillation protection and conduction system pacing, an approach aimed at producing a more coordinated and physiologic heartbeat.
