Medtronic plc 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 (LEADR) 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 (ICDs) 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, 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 (7-8 French), which can contribute to venous occlusion or tricuspid valve complications.

This innovative, low-profile defibrillation lead leverages a highly reliable pacing lead design to help achieve this goal, and the unique catheter-based method of implantation helps the physician place the lead in the optimal position for the patient." 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 led 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. Secondary and Ancillary Results: Reliability: The lead demonstrated reliable performance with zero (0) 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 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 (R-wave, pacing capture threshold, and pacing impedance) through 12 months. Nearly 12% of patients in the study received appropriate therapy (shock, or anti-tachycardia pacing [ATP) for dangerous 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. In addition to the LEADR results presented at Heart Rhythm 2024, Medtronic recently initiated the LEADR LBBAP study (Lead Evaluation for Defibrillation and reliability in Left Bundle Branch Area Pacing), which is assessing the safety and efficacy of the investigational OmniaSecure defibrillation leads when placed at the Left Bundle Branch-Optimized Cardiac Resynchronization Therapy (LOT-CRT).

Placing the defibrillation lead in the left bundle branch area is being evaluated as an alternative to right ventricular stimulation for sensing and cardiac death.