Medtronic has earned U.S. Food and Drug Administration (FDA) approval for its OmniaSecure defibrillation lead for placement in the heart’s right ventricle.

The lead is built on the company’s SelectSecure Model 3830 pacing lead and is delivered by a catheter. The lead connects to an implantable defibrillator to treat potentially life-threatening ventricular tachyarrhythmias, ventricular fibrillation (VT/VF) and bradyarrhythmias.

According to Medtronic, the OmniaSecure lead is the world’s smallest at 4.7 French (1.6 mm). The company believes it’s a meaningful innovation for electrophysiology, and it’s indicated for stimulation in the right ventricle for patients aged 12 and over—including those with smaller anatomies.

The company is also studying placing the defibrillation lead in the left bundle branch (LBB) area of the heart. This area can allow physiological pacing to more closely mimic the heart’s natural conduction system. At Heart Rhythm 2025, study results showed defibrillation success of 100% at implant when it’s implanted in the LBB area.

“FDA approval for the OmniaSecure defibrillation lead furthers our ability to offer physicians and patients a transvenous solution designed to be smaller to help minimize complications−including vascular complications and valve interaction−with strong, reliable lead durability. We engineered the OmniaSecure lead based on the trusted SelectSecure Model 3830 pacing lead, which has been the lead of choice for many physicians for more than 20 years,” said Alan Cheng, MD, chief medical officer of Medtronic’s Cardiac Rhythm Management business. “This milestone underscores our commitment to driving clinical innovations that help patients today while paving the way for future innovations that will usher in the next era of electrophysiology.”