Medtronic (NYSE:MDT) announced that its investigational EV ICD (extravascular implantable cardioverter defibrillator) system met trial endpoints.
The medtech giant designed its EV ICD system to treat dangerously fast heart rhythms that can lead to sudden cardiac arrest (SCA). Medtronic’s device aims to avoid certain risks of traditional, transvenous ICDs as its lead is placed outside the heart and veins, under the sternum using a minimally invasive approach.
Placement in such a location aims to help avoid long-term complications that may be associated with leads in the heart and veins, including vessel occlusion and risks for blood infections.
Results from the Extravascular Implantable Cardioverter Defibrillator (EV ICD) Pivotal Study were presented as late-breaking science at the European Society of Cardiology (ESC) Congress 2022 in Barcelona and simultaneously published in The New England Journal of Medicine, according to a news release. The first-of-its-kind defibrillator demonstrated a defibrillation success rate of 97.7% and met safety endpoints, Medtronic said.
Trial participants received the same therapies provided by traditional ICDs, including defibrillation, anti-tachycardia pacing (ATP), and back-up pacing therapies with the single implanted device, which is similar in size, shape, and longevity to traditional ICDs, Medtronic said.
“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, who presented the results 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.”
In the trial, 298 of 302 patients received defibrillation therapy at implant, surpassing the prespecified aim of 88%. Additionally, all discrete spontaneous arrhythmias (a total of 18) were successfully treated. The company also said that 33 defibrillation shocks were avoided by having the ATP function programmed “on.”
Medtronic reported that its study exceeded its safety endpoint, with 92.6% of patients free from major system and/or procedure-related major complications (hospitalization, system revision or death) at six months. The performance goal was set at 79%. There were also no major intraprocedural complications or unique complications related to the EV ICD procedure or system.
The company said that 25 major complications were observed in 23 out of 316 (7.3%) patients who underwent an implant attempt. Additionally, 29 (9.7%) patients experienced inappropriate shocks, 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 Dr. Alan Cheng, CMO of Medtronic’s cardiac rhythm management business. “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.”