Trial Endpoint Met—and Exceeded—in Medtronic’s Implant Cardioverter Defibrillator Trial

Having designed it to deal with the hazardously accelerated heart rhythms that can cause sudden cardiac arrest (SCA), medtech mainstay Medtronic’s investigation EV ICD (extravascular implantable cardioverter defibrillator) system has now met trial endpoints. Results from its testing phase were presented at the European Society of Cardiology (ESC) Congress 2022 in Barcelona as well as laid out in The New England Journal of Medicine. The first-of-its kind device demonstrated an impressive success rate of just under 98% and met its safety endpoints.

Medtronic honed its EV ICD to mitigate the typical risks associated with commonplace, transvenous ICDs. As opposed to those, its lead is placed via a minimally invasive approach outside the heart and veins, right under the sternum. This placement can help prevent long-term complications often caused by traditionally placed leads, such as blood infection or vessel occlusion. The extensive study in fact surpassed its safety endpoint, with 92.6% of patients not experiencing major system or procedure-induced complications, including hospitalization, system revision, or death, in six months.

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“We are very encouraged by the high defibrillation effectiveness and strong safety profile of the EV ICD system seen in the study, as we look to deliver less-invasive treatment options for patients at risk of sudden cardiac arrest,” said Dr. Ian Crozier of Christchurch Hospital in New Zealand, the man who made public the trial’s outcome at ESC Congress 2022. “These results demonstrate the potential for this novel technology to be used as a safe, successful approach for patients with life-threatening arrhythmias.”