October 23, 2023- Medtronic has received U.S. Food and Drug Administration (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 is the first-of-its-kind to provide 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.