Abbott has received both FDA and CE Mark approval for its UltiSynq defibrillation lead tech, which is designed to deliver both conduction system pacing and defibrillation therapy.
With the approvals, U.S. and EU patient candidates for both conduction system pacing and defibrillation protection now have an additional lead option.
Roughly 150,000 Implantable Cardioverter-Defibrillators (ICDs) are implanted in the U.S. and 140,000 in Europe annually. The numbers represent a significant patient population for whom pacing performance has meaningful long-term consequences, Abbot said in a statement.
Left bundle branch area pacing (LBBAP) is a conduction system pacing approach designed to restore the heart's natural pattern of electrical activation.
The UltiSynq defibrillation lead is designed for implantation in the left bundle branch area of the heart to deliver both cardiac pacing and defibrillation therapy.
While products like Medtronic’s SelectSecure 3830 and others offer LBBAP treatment, UltiSynq is unique in its ability to support both defibrillation therapy and LBBAP.
FDA approval and CE Mark of the tech were supported by results from the ASCEND CSP IDE trial in patients indicated for ICD or cardiac resynchronization therapy defibrillator (CRT-D) therapy.
The study showed that lead implantation was successful in 98.5% of the 205 patients tested and that 86% of patients achieved LBBP or likely LBBP, meaning the lead stimulated or likely stimulated the heart's natural conduction pathway.
UltiSynq is built on an ICD lead platform with distinct, true bipolar sensing that uses two closely spaced electrodes within the lead to accurately detect the heart’s signals from the ventricles. The technology is designed to deliver CSP benefits by working with the heart's natural electrical wiring system to support a coordinated heartbeat.
“UltiSynq demonstrates what is achievable when a lead is designed to support conduction system pacing,” said Pugazhendhi Vijayaraman, MD, system director of Cardiac Electrophysiology at Geisinger Heart Institute, Danville, Pa, in a statement.
“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.”