Dive Brief:
- Abbott has received the go-ahead to sell its UltiSynq defibrillation lead in the U.S. and European Union, the company said Tuesday.
- The device delivers conduction system pacing and defibrillation therapy to treat patients at risk of sudden cardiac death caused by life-threatening tachyarrhythmias, where the heart beats abnormally fast.
- Abbott simultaneously disclosed Food and Drug Administration approval and CE marking, which were based on clinical data showing the lead stimulated the heart’s natural conduction pathway.
Dive Insight:
Abbott designed UltiSynq by modifying its Optisure implantable cardioverter defibrillator lead for use in the left bundle branch area. Developers of medical devices for cardiac resynchronization therapy with a defibrillator have incorporated LBBA pacing amid evidence of its benefits over right ventricular pacing. However, the incorporation has necessitated an additional pacing lead within the LBBA.
UltiSynq, a purpose-built ICD lead for conduction system pacing, is designed for implantation within the LBBA. The device is designed for long-term attachment to compatible ICD or CRT-D systems in patients at risk of sudden cardiac death due to life-threatening tachyarrhythmias. Abbott validated the device in ASCEND CSP, a pivotal trial that enrolled patients undergoing ICD or CRT-D implantation.
Physicians implanted the UltiSynq lead successfully in 202 of 205 patients. The lead stimulated, or likely stimulated, the heart’s natural conduction pathway in 86% of patients. The other 14% had left ventricular septal pacing. Successful defibrillation was seen in all of the 120 patients who completed defibrillation testing. After three months, 97.5% of patients were free from major complications.
“The observed implant success, LBBAP capture results and defibrillation testing outcomes give physicians compelling data on this lead option for patients who require defibrillation protection and are candidates for conduction system pacing,” Pugazhendhi Vijayaraman, system director of cardiac electrophysiology at Geisinger Heart Institute, said in a statement.
The data supported authorizations that unlocked the U.S. and European markets. Physicians in the U.S. and Europe implant about 150,000 and 140,000 ICDs, respectively, each year. Abbott is targeting patients who are candidates for conduction system pacing and defibrillation protection.
