FDA Approves Medtronic’s OmniaSecure Defib Lead for LBB Placement

Medtronic has received U.S. Food and Drug Administration (FDA) approval to expand the indication of its OmniaSecure defibrillation lead.

OmniaSecure is now approved for placement in the left bundle branch (LBB) area and can be used for conduction system pacing (CSP), which mimics the heart’s natural physiology. Patients needing cardiac resynchronization may benefit from left bundle branch optimized cardiac resynchronization therapy (LOT-CRT), which combines CSP with left-ventricular pacing to improve outcomes.

The 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. OmniaSecure is the first lead approved for LBB placement and is the smallest defibrillation lead on the market (4.7 Fr, or 1.66 mm) and the only one approved for adults and adolescent patients aged 12 and up.

The lead has a lumenless construction, which enables it to be delivered via catheter for precise placement in the right ventricle, in addition to the LBB area. Conduction system pacing taps into the heart’s natural electrical system to provide therapy while avoiding cardiomyopathy or other complications associated with traditional pacing methods.

The OmniaSecure lead can offer treatment for dangerously fast arrhythmias while delivering conduction system pacing through the LBB area, when connected to a transvenous ICD or CRT-D, such as Medtronic’s Cobalt and Crome family of devices. Patients indicated for CRT may benefit when the OmniaSecure is paired with a left ventricular coronary sinus lead (i.e., biventricular or LOT-CRT configurations).

FDA approval was supported by data from the LEADR LBBAP trial (Lead Evaluation for Defibrillation and Reliability in Left Bundle Branch Area Pacing). Late-breaking data presented at Heart Rhythm 2025 showed the lead delivered 100% defibrillation success at implant and a 2.1% OmniaSecure-related major complication rate at three months when placed in the LBB area for physiologic pacing.

“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 Medtronic’s Defibrillation Solutions business. “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.”