Medtronic Shares Positive Data on OmniaSecure Defibrillation Lead

At this year’s European Society of Cardiology (ESC) Congress, researchers shared three new datasets that reinforce the safety and effectiveness of Medtronic’s OmniaSecure defibrillation lead.

The global LEADR LBBAP trial (Lead Evaluation for Defibrillation and Reliability in Left Bundle Branch Area Pacing) is evaluating the small-diameter OmniaSecure lead. It met safety and efficacy objectives at three months.

According to Medtronic, the OmniaSecure lead is the world’s smallest defibrillation lead at 4.7 Fr. It received U.S. Food and Drug Administration (FDA) approval in April 2025 for traditional placement in the right ventricle. The company said current defibrillation leads have a larger diameter than OmniaSecure, which can increase the likelihood of downstream complications like venous occlusion or tricuspid valve regurgitation.

“Left bundle branch area pacing continues to gain traction as a promising approach to restore normal physiologic activation in patients, including in those requiring ICD or CRT-D therapy,” said Pugazhendhi Vijayaraman, MD, cardiac electrophysiologist at Geisinger Wyoming Valley Medical Center in Wilkes-Barre, Pa., and 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-CRT-D.”

Results shared by Medtronic at ESC

Data from the LEADR LBBAP trial showed the lead delivered 100% defibrillation success and 2.3% OmniaSecure lead-related major complications when placed in the left bundle branch (LBB) for physiologic pacing.

A separate sub-analysis from the LEADR (Lead Evaluation for Defibrillation and Reliability) pivotal trial evaluating OmniaSecure in traditional locations in the right ventricle showed the lead had high defibrillation success and low occurrence of lead-related major complications in patients regardless of their race or age.

Black patients has a slightly lower defibrillation testing success rate (97%) compared to white and Asian patients (98.1% and 100%, respectively. Patients 30 years or younger had a 100% defibrillation success rate, with those older than 30 years at 98.1%.

The Asian, Black, and other population groups has a major complication-free rate of 100% at six months, and the white population had a 97.8% rate. Patients older than 30 had a 97% major complication-free rate at six months, whereas those 30 years or younger had a rate of 100%.

In a third analysis, seven pediatric patients (median age 14) were successfully implanted with the OmniaSecure lead under Compassionate Use from the FDA, with no major lead-related complications at implant or during follow up.

“Sudden cardiac arrest remains a leading cause of death, and we know certain patient populations face higher risks and less favorable outcomes,” said Pamela K. Mason, M.D., cardiac electrophysiologist at University of Virginia Health System in Charlottesville, Va., 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.”