Medtronic plc has secured U.S. Food and Drug Administration (FDA) approval for its OmniaSecure™ defibrillation lead, the world's smallest defibrillation lead with a diameter of just 1.6mm (4.7 French). The approval covers placement within the right ventricle for patients ages 12 and older, including those with smaller anatomies who may benefit from the lead's reduced size.
The OmniaSecure lead connects to implantable cardioverter-defibrillators (ICDs) or cardiac resynchronization therapy defibrillators (CRT-Ds) to treat potentially life-threatening cardiac conditions, including ventricular tachyarrhythmias and ventricular fibrillation. These conditions can cause the heart's lower chambers to beat too rapidly or quiver instead of contracting normally.
Engineering Advances in Lead Design
Built on Medtronic's highly reliable SelectSecure™ Model 3830 pacing lead platform, which has been trusted by physicians for over 20 years, the OmniaSecure lead is delivered via catheter and designed for precise placement. Its smaller diameter represents a significant innovation in electrophysiology, potentially reducing complications associated with larger leads.
"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," said Alan Cheng, M.D., chief medical officer of the Cardiac Rhythm Management business at Medtronic.
Existing defibrillation leads are typically larger in diameter, which can increase the risk of complications such as venous occlusion or tricuspid valve regurgitation. The OmniaSecure lead's smaller profile aims to address these concerns while maintaining effective therapy delivery.
Clinical Evidence Supporting Approval
The FDA approval was based on data from the global Lead Evaluation for Defibrillation and Reliability (LEADR) Pivotal Trial, which demonstrated that the OmniaSecure lead met its primary safety and effectiveness endpoints and exceeded prespecified performance goals when placed within the right ventricle. These results were presented at Heart Rhythm 2024 and simultaneously published in the Heart Rhythm journal.
Investigating Left Bundle Branch Area Placement
Beyond its approved indication, Medtronic is exploring new frontiers with the OmniaSecure lead. The company is studying its placement in the left bundle branch (LBB) area, which could enable physiologic pacing that more closely mimics the heart's natural conduction system.
At Heart Rhythm 2025 in San Diego, researchers presented late-breaking results from the LEADR LBBAP (Lead Evaluation for Defibrillation and Reliability in Left Bundle Branch Area Pacing) study. The findings showed 100% defibrillation success at implant when the lead was placed in the LBB area. Additionally, in the first 193 patients enrolled in the study, the OmniaSecure lead was successfully implanted per protocol in 95.8% of procedures, with no procedure-related major complications reported.
"The left bundle branch area is emerging as an option for more physiologic pacing for patients who receive an ICD or CRT-D to treat dangerous heart rhythms," explained Pugazhendhi Vijayaraman, M.D., cardiac electrophysiologist at Geisinger Wyoming Valley Medical Center in Wilkes-Barre, Pa., who presented the data. "The option to place a lead in the left bundle branch area may provide for physiologic pacing by engaging the heart's natural conduction system."
The LEADR LBBAP trial is a global, prospective, non-randomized, multi-center study that has enrolled approximately 300 patients at 24 sites across 11 countries in North America, Europe, Asia, and Australia. Patients indicated for an ICD are being followed for 3 months, while those indicated for CRT-D are being followed for 6 months post-implant.
Implications for Patient Care
For patients requiring defibrillation therapy, the OmniaSecure lead offers a new option that may be particularly beneficial for those with smaller anatomies or concerns about lead-related complications. The lead must withstand millions of heart contractions over a lifetime, flexing with each beat while maintaining reliable electrical conduction.
This FDA approval adds to Medtronic's portfolio of catheter-based lead solutions and underscores the company's commitment to advancing cardiac rhythm management technologies. While the OmniaSecure lead is currently approved only for right ventricular placement in the United States, the ongoing research into LBB area placement could potentially expand its applications in the future, pending additional FDA approval.
Medtronic plc, headquartered in Galway, Ireland, continues to focus on addressing challenging health problems through innovative technologies. With a global team of over 95,000 employees across more than 150 countries, the company's mission remains to alleviate pain, restore health, and extend life through its diverse portfolio of medical devices and therapies.
