SHERIDAN, WYOMING – May 5, 2025 – Medtronic plc (NYSE: MDT), a global leader in healthcare technology, has received U.S. Food and Drug Administration (FDA) approval for the OmniaSecure™ defibrillation lead—the smallest-diameter, catheter-delivered defibrillation lead for right ventricular implantation. This approval marks a major advancement in cardiac rhythm management, offering physicians a less invasive, highly durable solution to treat life-threatening arrhythmias in both adults and adolescents with smaller anatomies.
Strategic Advancement in Cardiac Rhythm Management
The FDA’s green light for the OmniaSecure lead strengthens Medtronic’s leadership in electrophysiology and expands its robust portfolio of transvenous lead solutions. At only 4.7 French (1.6mm) in diameter, the OmniaSecure lead builds on the proven SelectSecure™ Model 3830 pacing lead platform, already widely adopted in the clinical community for over two decades.
Indicated for right ventricular stimulation in patients aged 12 and older, the lead connects to implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) to manage ventricular tachyarrhythmias, fibrillation, and bradyarrhythmias.
According to Dr. Alan Cheng, chief medical officer of Medtronic’s Cardiac Rhythm Management business, “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.”
Clinical Validation and Safety Milestones
The FDA approval is backed by strong data from the pivotal Lead Evaluation for Defibrillation and Reliability (LEADR) Trial, where the OmniaSecure lead not only met its primary safety and efficacy endpoints but also surpassed predefined performance goals. This clinical endorsement highlights both its therapeutic reliability and its strategic potential in reducing risks such as:
- Venous occlusion
- Tricuspid valve regurgitation
- Lead fracture and system revisions
The lead's small size, coupled with catheter-based delivery, improves procedural precision while accommodating a broader patient population, including those with more delicate cardiovascular anatomies.
Investigational Use in the Left Bundle Branch Area Shows Promising Potential
Beyond traditional right ventricular placement, Medtronic is exploring investigational use of the OmniaSecure lead in the left bundle branch (LBB) area—a region associated with physiologic pacing that more closely replicates the heart’s natural electrical activity.
In late-breaking results presented at Heart Rhythm 2025, the LEADR LBBAP study revealed:
- 100% defibrillation success rate at implant among 162 patients
- 95.8% procedural implantation success among the first 193 patients
- No major procedural complications, including lead fracture, early helix issues, or deaths
“The left bundle branch area is emerging as an option for more physiologic pacing,” said Dr. Pugazhendhi Vijayaraman, cardiac electrophysiologist at Geisinger Wyoming Valley Medical Center. “These positive preliminary results for the LEADR LBBAP study are encouraging and highlight the potential versatility of the OmniaSecure defibrillation lead.”
Positioning for Long-Term Clinical Impact
The LEADR LBBAP trial continues to follow approximately 300 patients across 24 global sites in North America, Europe, Asia, and Australia. While LBB placement remains investigational, the early data aligns with broader trends in the industry seeking to:
- Enhance physiological pacing outcomes
- Reduce long-term complications from traditional RV pacing
- Increase personalization in cardiac therapy for complex patient profiles
Looking Ahead
The approval of the OmniaSecure defibrillation lead reinforces Medtronic’s role in pioneering safer, more efficient electrophysiological solutions. As clinical studies advance, the company is well positioned to usher in a new era of defibrillation therapy, potentially transforming care for millions worldwide.
Learn more at https://www.medtronic.com