Medtronic has received FDA approval for the Aurora EV-ICD MRI SureScan (Extravascular Implantable Cardioverter-Defibrillator) and Epsila EV MRI SureScan defibrillation lead to treat dangerously fast heart rhythms that can lead to sudden cardiac arrest (SCA). The Aurora EV-ICD system provides the life-saving benefits of traditional, transvenous ICDs with a lead (thin wire) placed under the breastbone, outside of the heart and veins. The Aurora EV-ICD delivers lifesaving defibrillation, anti-tachycardia pacing (ATP), and back-up (pause-prevention) pacing therapies via a device similar in size, shape, and longevity to traditional, transvenous ICDs.
FDA approval of the Medtronic Aurora EV-ICD system includes the system's proprietary procedure implant tools, and was supported by global pivotal trial results showing the system's safety and effectiveness, which were published in The New England Journal of Medicine. In the coming weeks, the Aurora EV-ICD system will be commercially available on a limited basis in the United States.
In the pivotal study, the device's effectiveness in delivering defibrillation therapy at implant was 98.7%, and there we no major intraprocedural complications, nor any unique complications observed related to the EV ICD procedure or system compared to transvenous and subcutaneous ICDs. Additionally, 33 defibrillation shocks were avoided1 by having ATP – which paces the heart to interrupt and terminate a dangerous rhythm – programmed "on." And at six months, 92.6% of patients (Kaplan-Meier estimate) were free from major system and/or procedure-related major complications such as hospitalization, system revision, or death.1
ICDs are highly effective in providing life-saving therapy for patients at risk of SCA, an electrical problem with the heart due to a dangerously fast heart rate (ventricular tachycardia) or irregular rhythm (ventricular fibrillation). If not treated immediately, SCA is often fatal (termed sudden cardiac death). Traditional ICDs typically are implanted below the collarbone, with the lead(s) threaded through the veins and into the heart.
The Aurora EV-ICD system is similar in size, shape, and longevity to traditional, transvenous ICDs. Unlike traditional ICDs, the Aurora EV-ICD system is implanted below the left armpit (in the left mid-axillary region) and the lead is placed under the breastbone (sternum) using a minimally invasive approach. The Epsila EV defibrillation lead is placed outside of the heart and veins, helping to avoid certain complications associated with transvenous leads, such as vascular injury and vessel occlusion (narrowing, blockage or compression of a vein).