Medtronic says OmniaSecure met primary safety, effectiveness endpoints

Medtronic announced that its investigational OmniaSecure defibrillation lead met its primary safety and effectiveness endpoints, exceeding prespecified performance goals, in the global Lead Evaluation for Defibrillation and Reliability Pivotal Trial. Late breaking results were presented at Heart Rhythm 2024 and simultaneously published in the journal Heart Rhythm. Worldwide, the OmniaSecure defibrillation lead is investigational and not yet approved for sale or distribution. Implantable cardioverter defibrillators are the gold standard for preventing sudden cardiac death. Yet transvenous defibrillator leads, which are thin wires connected to the ICD and threaded through the veins into the heart muscle, remain the weakest point of the system,1 given the harsh environment inside the human body where the lead must remain attached and yet flex with millions of heart contractions over a patient’s lifetime. Existing defibrillation leads have a large diameter, which can contribute to venous occlusion or tricuspid valve complications. For patients where an extravascular defibrillator may not be appropriate, Medtronic engineers designed the OmniaSecure defibrillation lead based on the Medtronic SelectSecure Model 3830 pacing lead, which has offered safe and effective treatment to patients for more than 20 years. By beginning with this highly reliable pacing lead and building a larger lead suitable for defibrillation therapy, the Medtronic OmniaSecure lead is the world’s smallest transvenous defibrillation lead. Defibrillation testing conducted at device implantation in 119 patients was successful in 97.5% of cases. The study exceeded the prespecified efficacy goal of 88%. At six months, 97.1% of 657 patients with an implant attempt were free from lead-related major complications such as hospitalization, lead fracture, system revision, or death. The study exceeded the prespecified safety performance goal of 90%. There were no lead-related major complications observed between six and 12 months. The LEADR Pivotal trial is a prospective, multicenter, single-arm, non-randomized, global clinical study that assessed the safety and effectiveness of the Medtronic OmniaSecure defibrillation lead when placed at traditional locations in the right ventricle to achieve defibrillation, sensing, pacing and cardioversion in patients at risk of sudden cardiac death. The study enrolled 675 patients at 45 sites in 17 countries in North America, Europe, Asia, and Australia. The lead demonstrated reliable performance with zero study lead fractures through an average follow up of 12.7+/-4.8 months. Medtronic developed and validated an in-vitro model that accurately predicts lead reliability out to 10 years,2 and then applied that model within the study to predict a fracture-free survival of 99.9% at two years for the investigational OmniaSecure lead. The lead also demonstrated a 97.9% implant success rate, and stable electricals through 12 months. Nearly 12% of patients in the study received appropriate therapy for dangerously fast ventricular arrhythmias by 14.0+/-5.0 months. ATP terminated 74.9% of episodes, preventing a shock in 49 patients. Medtronic plans to present additional reliability model results from the LEADR study in the coming months.