Expanded approval covers placement in the left bundle branch (LBB) area. It enables the use of OmniaSecure in conduction system pacing (CSP), closely mimicking the heart’s natural physiology.
Patients in need of cardiac resynchronization may also benefit from left bundle branch optimized cardiac resynchronization therapy (LOT-CRT), Medtronic says. This therapy combines CSP with left ventricular pacing to further improve patient outcomes.
OmniaSecure connects to an implantable defibrillator to treat potentially life-threatening ventricular tachyarrhythmias, ventricular fibrillation (VT/VF) and bradyarrhythmias. Built on the company’s SelectSecure Model 3830 pacing lead for catheter delivery, it adds to the wide-ranging Medtronic portfolio of lead solutions for precise delivery and placement.
Medtronic labels it the world’s smallest defibrillation lead, coming in at 4.7 Fr, or 1.6 mm. That equals about the diameter of graphite in a wooden pencil.
The defibrillator lead won FDA approval for right ventricle placement in April 2025 and launched at the start of this year.
Medical Design & Outsourcing: How Medtronic developed OmniaSecure, the world’s smallest defibrillation lead
More about the Medtronic defibrillation lead and its latest approval
Medtronic supported the latest approval with data shared in September 2025. Its global LEADR LBBAP trial evaluated the small-diameter defibrillation lead. It found that OmniaSecure met safety and efficacy objectives at three months.
Implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) prevent sudden cardiac arrest. For patients requiring chronic pacing and defibrillation therapy, OmniaSecure can offer treatment for dangerously fast arrhythmias while delivering conduction system pacing in the LBB area.
The lead combines reliability and durability with a lumenless construction, meaning it has no hollow channel on the inside. This enables precise placement in the heart via catheter. Conduction system pacing taps into the heart’s natural electrical system to provide needed therapy while avoiding cardiomyopathy or other complications.
Medtronic says that approval expands its comprehensive portfolio of lumenless leads. Its CSP technologies aim to deliver stability and long-term performance to further enhance procedural precision and versatility.
Commentary from company officials and doctors
Trevor Cook, VP and GM of the Defibrillation Solutions business at Medtronic, said:
“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. 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.”
Dr. Pugazhendhi Vijayaraman, cardiac electrophysiologist at Geisinger Wyoming Valley Medical Center in Wilkes-Barre, Pa., and principal investigator of the LEADR LBBAP study, said:
“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.”
