Medtronic plc a global leader in healthcare technology, today announced that its investigational EV ICD™ System – a first-of-its-kind 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. Findings from the Extravascular Implantable Cardioverter Defibrillator Pivotal Study were presented as late-breaking science today at the European Society of Cardiology Congress 2022 in Barcelona and simultaneously published in The New England Journal of Medicine. Worldwide, the EV ICD system is investigational and not yet approved for sale or distribution.
The Medtronic 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. Placing the lead in this location is designed to help avoid long-term complications that may be associated with leads in the heart and veins, such as vessel occlusion 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.
"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. These results demonstrate the potential for this novel technology to be used as a safe, successful approach for patients with life-threatening arrhythmias."
Ian Crozier, MB, CHB, M.D., Christchurch Hospital, Christchurch, New Zealand, who presented the results at ESC Congress 2022
At six months, 25 major complications were observed in 23 of 316 patients who underwent an implant attempt (7.3%). Twenty-nine patients experienced inappropriate shocks (9.7%, average 10.6 months follow up), most commonly due to P-wave oversensing, which was more frequent in patients implanted early in the study and less frequent among patients implanted later in the study.
"These pivotal data mark the start of a new era in ICD therapy for patients who are at significant risk of dangerously fast heart rhythms," said Alan Cheng, M.D., chief medical officer of the Cardiac Rhythm Management business, which is part of the Cardiovascular Portfolio at Medtronic. "Today's findings are an important clinical milestone toward our goal of delivering a one-system, one-procedure extravascular ICD solution that prevents sudden cardiac arrest while improving the patient experience with a smaller device and moving the lead out of the veins and placing it under the breastbone. The EV ICD system retains the benefits of a completely extravascular system while providing ATP, pause prevention pacing and low defibrillation energy."
The EV ICD Pivotal study is a prospective, multicenter, single-arm, non-randomized, pre-market clinical study that assessed the safety and effectiveness of the Medtronic EV ICD system for patients at risk of sudden cardiac death. The EV ICD Pivotal study enrolled 356 patients at 46 sites in 17 countries in North America, Europe, the Middle East, Asia, Australia and New Zealand. Medtronic has received FDA approval for a Continued Access Study while the agency reviews the company's EV ICD pre-market application.
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