Manufacturing & Production

Medtronic’s extravascular defibrillator receives CE mark

Medtronic has received the CE mark for its extravascular defibrillator. The Aurora EV-ICD™ MRI SureScan™ and Epsila EV™ MRI SureScan™ defibrillation lead treat abnormally fast heart rhythms, which can lead to sudden cardiac arrest.
Implantable cardioverter-defibrillators (ICDs) are a highly effective treatment for sudden cardiac arrest (SCA). They detect when the patient is experiencing an abnormally fast heart rate and deliver therapy to terminate a potentially fatal arrhythmia.
The Aurora EV-ICD system offers the same defibrillation, anti-tachycardia pacing (ATP) and back-up pacing therapies as traditional ICDs, however its thin wire is placed outside of the heart and veins. Traditional transvenous ICDs are implanted in the chest and attached to leads, which are threaded through veins into the heart. Aurora EV-ICD is implanted below the left armpit, with the Epsila EV lead being placed under the sternum, avoiding any intrusion into the veins and heart. This avoids certain long-term risks such as vessel occlusion and blood infections.
Aurora EV-ICD received its CE mark after the Extravascular Implantable Cardioverter Defibrillator (EV ICD) Pivotal Study met its safety and effectiveness endpoints.
Alan Cheng, MD, chief medical officer of the Cardiac Rhythm Management business, which is part of the Cardiovascular Portfolio at Medtronic stated, “We are proud to be the first company to offer a complete one-system, one-procedure extravascular ICD solution, which maintains the patient benefits of traditional, transvenous ICDs without the risk of leads in the heart and vasculature. This approval is a significant milestone in achieving our goal of delivering a defibrillation solution that treats sudden cardiac arrest while improving the patient experience.”