Built for high reliability, world's only lumenless defibrillation lead approved for placement in the left bundle branch area

GALWAY, Ireland, March 23, 2026 /PRNewswire/ -- Medtronic plc (NYSE:MDT), a global leader in healthcare technology, received U.S. Food and Drug Administration (FDA) approval for an expanded indication for the 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 closely mimics the heart's natural physiology. Additionally, patients in need of cardiac resynchronization may benefit from left bundle branch optimized cardiac resynchronization 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 cardiac resynchronization therapy defibrillator (CRT-D) to treat potentially life-threatening ventricular tachyarrhythmias, ventricular fibrillation (VT/VF), and bradyarrhythmias. 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 (4.7 French, or 1.66 mm) and the only one approved for adults and adolescent pediatric patients ages 12 and up.

Engineered based on the reliable Medtronic SelectSecure™ Model 3830 pacing lead − the first pacing lead to receive FDA approval for CSP in 2022 − the OmniaSecure defibrillation lead is built for high reliability and durability with its lumenless construction (no hollow channel on the inside), 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 works by tapping into the heart's natural electrical system, providing patients needed therapy while avoiding cardiomyopathy or other complications sometimes associated with traditional pacing methods.