Researchers recently presented three new datasets reinforcing the safety and performance of Medtronic’s OmniaSecure defibrillation lead at the 2025 European Society of Cardiology (ESC) congress (29 August–1 September, Madrid, Spain), as per a press release from the company.
The global LEADR LBBAP trial evaluating the small-diameter OmniaSecure defibrillation lead met its safety and efficacy objectives at three months, with data from the full cohort of study patients showing that the lead 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.
Physiologic pacing—achieved by stimulating the LBB—more closely mimics the heart’s natural conduction, according to Medtronic. Globally, the OmniaSecure defibrillation lead is investigational for use in the LBB and will require separate regulatory approvals in the future, the company’s recent release adds.
Having been built for reliability and engineered based on the SelectSecure model 3830 pacing lead, OmniaSecure is described by Medtronic as “the world’s smallest defibrillation lead” (4.7Fr or 1.6mm). The device received US Food and Drug Administration (FDA) approval in April 2025 for traditional placement in the right ventricle. Medtronic claims that existing defibrillation leads are larger in diameter than the OmniaSecure lead, which may increase the likelihood of downstream complications like venous occlusion or tricuspid valve regurgitation.
“LBB area pacing continues to gain traction as a promising approach to restore normal physiologic activation in patients, including in those requiring ICD [implantable cardioverter defibrillator] or CRT-D [cardiac resynchronisation therapy with a defibrillator],” said Pugazhendhi Vijayaraman (Geisinger Wyoming Valley Medical Center, Wilkes-Barre, USA), principal investigator of the LEADR LBBAP study. “These results build on our earlier findings, and reinforce the clinical safety and defibrillation efficacy of the OmniaSecure defibrillation lead when used for conduction system pacing, including in advanced applications like LOT [LBB-optimised therapy] CRT-D.”
Separately, a data subanalysis from the LEADR pivotal trial—evaluating the OmniaSecure defibrillation lead in traditional locations within the right ventricle—showed that the lead exhibited high defibrillation success and a low occurrence of lead-related major complications in patients regardless of their race or age. Key results are as follows:
- Black patients experienced a slightly lower defibrillation testing success rate (91.7%) compared to white and Asian patients (98.1% and 100%, respectively)
- Patients aged 30 years or younger had a 100% defibrillation testing success rate, with those older than 30 years of age at 98.1%
- Separately, Asian, Black and other population groups experienced a major complication-free rate of 100% at six months compared to 97.8% in the white patient population group, and patients older than 30 years had a 97% major complication-free rate at six months, whereas those 30 years or younger had a rate of 100%
According to Medtronic, studies show that sudden cardiac arrest (SCA) is on the rise among adults aged 25–44 years, with the relative age‐adjusted mortality rate nearly doubling from 1999 to 2020. And, despite Black patients being disproportionately more likely to experience SCA and qualify for device therapy, they are 31% less likely than white patients to receive implantable defibrillators.
“SCA remains a leading cause of death, and we know certain patient populations face higher risks and less favourable outcomes,” said Pamela Mason (University of Virginia Health System, Charlottesville, USA), who presented these data at ESC 2025. “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.”
In a third analysis, seven paediatric patients (median age, 14 years) were successfully implanted with the OmniaSecure lead under compassionate use from the US FDA, with no major lead-related complications at implant or during follow-up. The OmniaSecure lead is the first ever defibrillation lead approved by the US FDA for use in traditional locations within the right ventricle for both adult and adolescent paediatric cases (patients aged 12 years and older) in the USA, Medtronic claims.
