Abbott Wins US and EU Approval for New Heart Lead

Abbott has received regulatory clearance to sell its UltiSynq defibrillation lead in the United States and the European Union. The company announced the dual authorizations on Tuesday, which will allow the device to launch in both markets. The UltiSynq is designed to deliver conduction system pacing and defibrillation therapy to treat patients at risk of sudden cardiac death caused by life-threatening tachyarrhythmias. FDA approval and CE marking were granted based on clinical data showing the lead stimulates the heart’s natural conduction pathway.

The device’s design and trial results

Abbott developed UltiSynq by modifying its Optisure implantable cardioverter defibrillator lead for use in the left bundle branch area. This approach differs from standard methods that require an additional pacing lead within the left bundle branch area. The device is intended for long-term attachment to compatible ICD or CRT-D systems. Abbott validated the device in the ASCEND CSP key trial, which enrolled patients undergoing ICD or CRT-D implantation.

Physicians successfully implanted the UltiSynq lead in 202 of 205 patients. The lead stimulated, or likely stimulated, the heart’s natural conduction pathway in 86% of patients. The remaining 14% had left ventricular septal pacing. Successful defibrillation was observed in all 120 patients who completed defibrillation testing. After three months, 97.5% of patients were free from major complications.

Market context

The data supported the authorizations that opened the U.S. and European markets. Physicians in the U.S. and Europe implant approximately 150,000 and 140,000 ICDs, respectively, each year. Abbott is targeting patients who are candidates for conduction system pacing and require defibrillation protection. The device aims to offer a streamlined alternative to current methods that involve adding a separate pacing lead to the left bundle branch area.