Medtronic has received US Food and Drug Administration (FDA) approval for an expanded indication with its OmniaSecure defibrillation lead. Now approved for placement in the left bundle branch (LBB) area, the lead can be used for conduction system pacing (CSP), which is intended to closely mimic the heart’s natural physiology. Additionally, according to Medtronic, patients in need of cardiac resynchronisation may benefit from LBB-optimised cardiac resynchronisation therapy (LOT-CRT)—a novel therapy that combines CSP with left ventricular pacing to further improve patient outcomes.
The OmniaSecure defibrillation lead connects to an implantable cardioverter-defibrillator (ICD) or CRT defibrillator (CRT-D) to treat ventricular tachyarrhythmia (VT), ventricular fibrillation (VF), and bradyarrhythmia. In addition to being the first defibrillation lead approved for placement in the LBB area, the OmniaSecure lead is the smallest-diameter defibrillation lead on the market (4.7Fr), and the only one approved for adults and adolescent paediatric patients aged 12 year or older, according to Medtronic.
Engineered based on Medtronic’s SelectSecure Model 3830 pacing lead—which became the first pacing lead to receive US FDA approval for CSP in 2022—the OmniaSecure defibrillation lead has been built for high reliability and durability with its ‘lumenless’ construction, which enables the lead to be delivered via catheter for precise placement in the right ventricle in addition to the LBB area.
“Conduction system pacing is a rapidly growing therapy for patients who need a pacemaker. Now, patients who require a defibrillator and pacing have an option that can safely deliver life-saving defibrillation therapy, and activate the heart’s natural electrical system to enable a more synchronous, physiologic pattern,” said Trevor Cook, vice president and general manager of the Defibrillation Solutions business within Medtronic’s Cardiac Rhythm Management operating unit. “This approval underscores the versatility of the OmniaSecure defibrillation lead and supports its use across a variety of implant approaches to best serve a broad range of patients.”
According to Medtronic, US FDA approval for the OmniaSecure defibrillation lead was supported by data from the global LEADR LBBAP trial, which demonstrated its safety and effectiveness via a high rate of defibrillation success at implant (100%) and a low OmniaSecure-related major complication rate at three months (2.1%) when placed in the LBB area for physiologic pacing.
The company also notes in a recent press release that longer-term LBB area and LOT-CRT results from the study will be presented at Heart Rhythm 2026 (23–26 April, Chicago, USA).
“The robust body of clinical evidence from the LEADR LBBAP study supports the OmniaSecure defibrillation lead as a safe and effective way to activate physiologic pacing through the left bundle branch area, or in applications like LOT-CRT, while also demonstrating reliable defibrillation success,” commented LEADR LBBAP principal investigator Pugazhendhi Vijayaraman (Geisinger Wyoming Valley Medical Center, Wilkes-Barre, USA).
The present approval is said to expand Medtronic’s comprehensive portfolio of lumenless leads and accessories approved by the US FDA for CSP, including the SelectSecure Model 3830 pacing lead as well as the recently cleared C320LBB delivery catheter and the 5944RL rotatable connector. Together, these CSP solutions deliver stability and long-term performance that further enhance procedural precision and versatility, according to Medtronic.
Following US FDA approval for placement in traditional locations in the right ventricle, the OmniaSecure defibrillation lead was launched commercially in the USA in January 2026.
