- In April 2025, Medtronic received FDA approval for its OmniaSecure defibrillation lead, the smallest-diameter, lumenless defibrillation lead designed for implantable cardioverter-defibrillators (ICDs). This innovation aims to enhance patient safety and device reliability by reducing complications associated with larger leads, such as venous occlusion and tricuspid valve issues. The OmniaSecure lead demonstrated a 97.5% success rate in defibrillation testing and a 97.1% complication-free rate at six months in the LEADR Pivotal Trial, exceeding prespecified performance goals. Its successful development and clinical performance are expected to strengthen Medtronic's position in the cardiac rhythm management market and potentially set a new standard for ICD lead design
- In October 2023, Medtronic received FDA approval for its Aurora Extravascular Implantable Cardioverter-Defibrillator (EV-ICD) System, a first-of-its-kind device designed to treat life-threatening ventricular arrhythmias. Unlike traditional ICDs that require leads to be placed inside the heart and veins, the Aurora EV-ICD features a lead positioned under the sternum, outside the heart and vascular system. This design aims to reduce complications associated with transvenous leads, such as vascular injury and vessel occlusion. The system provides life-saving defibrillation, anti-tachycardia pacing, and back-up pacing therapies, all within a device similar in size and longevity to conventional ICDs. Clinical studies demonstrated a 98.7% success rate in terminating ventricular arrhythmias at implant, with a 92.6% freedom from major system or procedure-related complications at six months. The approval of the Aurora EV-ICD is expected to expand treatment options for patients at risk of sudden cardiac arrest and potentially set a new standard in ICD therapy
