CE Mark for the Aurora EV-ICD MRI SureScan (Extravascular Implantable Cardioverter-Defibrillator) and Epsila EV MRI SureScan defibrillation lead.- Medtronic

The Aurora EV-ICD system provides the life-saving benefits of traditional ICDs while avoiding certain risks because its lead (thin wire) is placed outside the heart and veins. The Aurora EV-ICD system is investigational in the United States.

Patients implanted with the Aurora EV-ICD system have defibrillation, anti-tachycardia pacing (ATP), and back-up pacing therapies available to them via a single implanted device that is similar in size, shape, and longevity to traditional ICDs. The system approval also includes proprietary procedure implant tools. The Aurora EV-ICD system is expected to be commercially available in autumn 2023 in select countries in Europe.

CE Mark approval follows the Extravascular Implantable Cardioverter Defibrillator (EV ICD) Pivotal Study meeting its safety and effectiveness endpoints; data was presented as late breaking science at the European Society of Cardiology (ESC) 2022 and simultaneously published in The New England Journal of Medicine.

In the global pivotal study, the device's effectiveness in delivering defibrillation therapy at implant was 98.7%. This reflects a greater defibrillation efficacy for the EV-ICD than historical transvenous ICD studies,and comparable efficacy to the subcutaneous ICD despite EV-ICD's smaller device size. Further, the efficacy of ATP – which paces the heart to interrupt and terminate a dangerous rhythm, potentially avoiding a defibrillation shock – in the EV ICD study was comparable to ATP efficacy in transvenous defibrillators. In total, 33 shocks were avoided by having ATP programmed "on."

The Aurora EV-ICD system includes features available in Medtronic transvenous ICDs, and offers additional advantages that are not available with subcutaneous ICDs including: i.Anti-tachycardia Pacing (ATP), which terminates ventricular arrhythmias (rapid and/or chaotic activity of the heart that can cause SCA episodes). ii. Pause Prevention Pacing, which provides back-up pacing for brief, intermittent, heartbeat pauses. iii. 40 Joule Defibrillation Energy, which delivers life-saving shocks in a device the size of transvenous ICDs (33 cc). iv.Medtronic exclusive PhysioCurve design, which may offer increased patient comfort and acceptance. v. Up to 11.7-year projected longevity (a predicted increase compared to the subcutaneous ICD), potentially leading to fewer device replacement procedures during a patient's lifetime.

Additionally, at six months, 92.6% of patients (Kaplan-Meier estimate) in the pivotal study were free from major system and/or procedure-related major complications such as hospitalization, system revision, or death. There were no major intraprocedural complications, nor any unique complications observed related to the EV-ICD procedure or system.

See-Friedman P, Murgatroyd F, Boersma LVA, et al." Efficacy and Safety of an Extravascular Implantable Cardioverter-Defibrillator". N Engl J Med 2022; 387:1292-1302.