Medtronic Says Extravascular ICD Meets Clinical Trial's Safety And Effectiveness Endpoints

(RTTNews) - Medtronic plc (MDT) said that its investigational EV ICD System - a defibrillator with the lead placed under the breastbone, outside of the heart and veins - achieved a defibrillation success rate of 98.7% and met its safety endpoints in a global clinical trial.

The Medtronic Extravascular Implantable Cardioverter Defibrillator or EV ICD system is designed to treat dangerously fast heart rhythms that can lead to sudden cardiac arrest, while avoiding certain risks of traditional, transvenous ICDs because its lead (thin wire) is placed outside the heart and veins, under the breastbone (sternum) using a minimally invasive approach.

The company noted that the placing the lead in the location is designed to help avoid long-term complications that may be associated with leads in the heart and veins, such as vessel occlusion (narrowing, blockage or compression of a vein) and risks for blood infections.

The lead is connected to a device that is implanted below the left armpit. Clinical trial participants received the same therapies provided by traditional ICDs, including defibrillation, anti-tachycardia pacing (ATP), and back-up pacing therapies with this single implanted device that is similar in size, shape, and longevity to traditional ICDs.

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