On 25 April, 2025, the U.S. Food and Drug Administration (FDA) approved the OmniaSecure defibrillation lead, a catheter-delivered, 1.6 mm, lumenless lead designed for implantation in the right ventricle.1,2 Built on the long-used SelectSecure Model 3830 pacing lead platform, OmniaSecure is intended for use with implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) in adult and adolescent patients aged 12 and older.
The lead is designed to connect to an implantable defibrillator and treat ventricular tachyarrhythmias, ventricular fibrillation (VT/VF), and bradyarrhythmias.1 As the smallest-diameter defibrillation lead currently available, OmniaSecure may offer procedural advantages in certain patient populations, particularly those with smaller vasculature. The reduced diameter is intended to limit risks associated with a larger-diameter lead, such as venous occlusion and tricuspid valve regurgitation, though long-term comparative outcomes remain under investigation.
The FDA approval is based on results from the pivotal LEADR trial (ClinicalTrials.gov identifier: NCT04863664), a prospective, multicenter, single-arm study that evaluated the safety and effectiveness of the OmniaSecure lead when implanted in the right ventricle.2,3 The study met its primary endpoints and exceeded prespecified performance goals.
In the study of 643 patients, the investigational lead was successfully implanted in 99.5% of cases, with 505 completing 12-month follow-up.2 Defibrillation testing in 119 patients showed a 97.5% success rate. The Kaplan-Meier estimated freedom from study lead–related major complications was 97.1% at 6 and 12 months. The study exceeded primary safety and efficacy endpoints, with no lead fractures and stable electrical performance over a mean follow-up of 12.7 months.
The OmniaSecure lead is also being investigated for use in the left bundle branch area.1 Early results from the LEADR LBBAP study (ClinicalTrials.gov identifier: NCT04863664) presented at Heart Rhythm 2025 showed successful implantation per protocol in 95.8% of the procedures and a 100% defibrillation success at implant.3,4 There were also no procedure-related major complications. This indication remains under investigation and is not yet FDA-approved.
References
- Medtronic. Medtronic receives FDA approval for smallest-diameter, lumenless defibrillation lead, the OmniaSecure™ lead and announces investigational clinical study results. [Press release] 2025. Available at: https://news.medtronic.com/2025-04-25-Medtronic-receives-FDA-approval-for-smallest-diameter,-lumenless-defibrillation-lead,-the-OmniaSecure-TM-lead-and-announces-investigational-clinical-study-results (accessed 30 May 2025).
- Crossley GH, Sanders P, Hansky B, et al. Safety, efficacy, and reliability evaluation ofa novel small-diameter defibrillation lead: Global LEADR pivotal trial results. Heart Rhythm. 2024;21:1914–1922.
- ClinicalTrials.gov. Lead EvaluAtion for Defibrillation and Reliability (LEADR) / Lead Evaluation for Defibrillation and Reliability in Left Bundle Branch Area Pacing (LEADR LBBAP). ClinicalTrials.gov identifier: NCT04863664. Available at: https://clinicaltrials.gov/study/NCT04863664 (accessed 30 May 2025).
- Vijayaraman P, Mason PK, Liu X, et al. Left Bundle Branch Area Placement Of A Novel Small-Diameter Defibrillation Lead: Defibrillation Results Of The LEADR LBBAP Clinical Trial. Presented at: Heart Rhythm 2025, San Diego, CA, USA, 25 April, 2025. Abstract LB-495066-03.
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Editor: Victoria Jones, Senior Content Editor
Citation: FDA Approves the World’s Smallest-Diameter Defibrillation Lead for Placement Within the Right Ventricle. touchCARDIO. 30 April 2025.
Disclosures: This article was created by the touchCARDIO team utilizing AI as an editorial tool (ChatGPT (GPT-4o) [Large language model]. https://chat.openai.com/chat.) The content was developed and edited by human editors. No funding was received in the publication of this article.
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