Medtronic receives FDA approval for smallest-diameter, lumenless defibrillation lead, the OmniaSecure™ lead and announces investigational clinical study results

Core Insights - Medtronic has received FDA approval for the OmniaSecure™ defibrillation lead, which is designed for precise placement in the right ventricle and is the world's smallest defibrillation lead at 4.7 French (1.6mm) [1][5] - The OmniaSecure lead is built on the SelectSecure™ Model 3830 pacing lead and aims to treat life-threatening ventricular tachyarrhythmias and bradyarrhythmias [1][3] - Investigational studies presented at Heart Rhythm 2025 show a 100% defibrillation success rate when the lead is implanted in the left bundle branch (LBB) area, indicating potential for physiologic pacing [2][6] Company Overview - Medtronic is a global leader in healthcare technology, headquartered in Galway, Ireland, with a mission to alleviate pain, restore health, and extend life [10] - The company employs over 95,000 people across more than 150 countries and offers a wide range of medical technologies and therapies [10] Product Details - The OmniaSecure lead connects to an implantable defibrillator and is indicated for use in adults and adolescent patients aged 12 and up, including those with smaller anatomies [1] - The lead's design minimizes complications associated with larger-diameter leads, such as venous occlusion and tricuspid valve regurgitation [4][5] - The LEADR LBBAP study, which is a global, prospective, non-randomized trial, has enrolled approximately 300 patients across 24 sites in 11 countries [9]