Medtronic Receives FDA Approval for Aurora EV-ICD™ MRI SureScan™ Defibrillator

Medtronic has received U.S. 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, delivering 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.

The FDA approval of the Aurora EV-ICD System, which includes the system’s proprietary procedural implantation tools, was supported by global pivotal trial results demonstrating the system’s safety and effectiveness published in the New England Journal of Medicine.

The Aurora EV-ICD System will be commercially available on a limited basis in the United States in the coming weeks.

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