Medtronic (NYSE: MDT) today announced new datasets backing the safety and performance of its OmniaSecure defibrillation lead.
The global LEADR LBBAP trial evaluated the small-diameter defibrillation lead. It found that OmniaSecure met safety and efficacy objectives at three months. Investigators presented findings at the 2025 European Society of Cardiology (ESC) Congress in Madrid.
Implantable cardioverter defibrillators (ICDs) provide life-saving cardiac interventions. But Medtronic aims to improve upon one area of weakness: the transvenous leads. Medtronic labeled OmniaSecure as 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.
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.
The defibrillator lead won FDA approval for right ventricle placement in April.
A look at the data shared by Medtronic at ESC
In the data shared at ESC 2025, Medtronic said OmniaSecure delivered high defibrillation success (100%) and low OmniaSecure lead-related major complications (2.3%) when placed in the left bundle branch (LBB) area for physiologic pacing. The device remains investigational for LBB pacing.
Separately, a sub-analysis from the LEADR pivotal trial evaluated the lead in traditional locations in the right ventricle. OmniaSecure demonstrated high defibrillation success and a low occurrence of lead-related major complications in patients regardless of their race or age.
Black patients experienced a slightly lower defibrillation testing success rate (91.7%) compared to white and Asian patients (98.1% and 100%, respectively). Patients 30 years or younger had a 100% defibrillation testing success rate. Those older than 30 years of age came in at 98.1%.
Separately, Asian, Black and other population groups experienced a major complication-free rate of 100% at six months. The white patient population group had a 97.8% rate. Patients older than 30 had a 97% major complication-free rate at six months, while those 30 or younger had a rate of 100%.
A third analysis saw seven pediatric patients (median age 14) successfully received OmniaSecure implants. They had no major lead-related complications at implant or during follow-up. OmniaSecure is the first FDA-approved defibrillation lead for traditional locations within the right ventricle for both adult and adolescent pediatric use for patients 12 years of age and older in the U.S.
“Sudden cardiac arrest remains a leading cause of death, and we know certain patient populations face higher risks and less favorable outcomes,” said Dr. Pamela K. Mason, cardiac electrophysiologist at University of Virginia Health System in Charlottesville, Virginia, who presented the data at the meeting. “As physicians, having a reliable defibrillation lead that performs well across populations gives us greater confidence in our ability to protect more patients from life-threatening arrhythmias and sudden cardiac death.”
