Medtronic Gets FDA Approval For Extravascular Defibrillator To Treat Abnormal Heart Rhythms

(RTTNews) - Medtronic plc (MDT) said it has received U.S. Food and Drug Administration 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.

In the coming weeks, the Aurora EV-ICD system will be commercially available on a limited basis in the United States, the company said in a statement.

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.

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