Medtronic, the world’s largest medical device company, has launched a pivotal new study across the world to assess its new implantable defibrillator system (which has leads placed outside of the heart and veins rather than in) on its ability to treat dangerously fast heart rhythms.
The study will evaluate the success of its Extravascular Implantable Cardioverter Defibrillator (EV ICD), which is presently only in the investigational stage. It is roughly the same size as the traditional ICD, but is enhanced with a thin wire that will be placed outside the heart and veins.
An estimated 400 patients from 60 sites – particularly in North America, Europe and Asia – around the world will partake in the pre-market clinical trial and will be assessed at regular intervals.
This particular device will aim to provide potentially lifesaving defibrillation therapy, terminate arrhythmias by providing anti-tachycardia pacing, and address abnormally slow heart rates as well.
Dr Rob Kowal, the chief medical officer and vice president of medical affairs in the Cardiac Rhythm and Heart Failure division of Medtronic’s Cardiac and Vascular Group, said: “With the EV ICD system, we aspire to deliver a new standard in ICD therapy for patients who are at significant risk of life-threatening rhythms in the lower chambers of the heart.
“Our engineers have spent years developing this innovative system, and we appreciate the high level of interest and collaboration among our expert investigators and regulatory authorities worldwide to carry out the EV ICD pivotal study.”