Medtronic has announced that its investigational Extravascular Implantable Cardioverter Defibrillator (EV ICD) System met safety endpoints and achieved 98.7% success rate in an international clinical trial.
The first-of-its-kind defibrillator has been designed for treating the dangerously fast heartbeat which may lead to sudden cardiac arrest (SCA).
Using a minimally invasive approach, the lead (thin wire) of the system is placed outside the heart and veins, under the breastbone (sternum) and will be connected to a device, which will be implanted below the left armpit.
This is said to avoid long-term complications which may be related to leads in the heart and veins, including vessel occlusion and blood infection risks.
The non-randomised, multicentre, pre-market EV ICD Pivotal study has been designed for assessing the effectiveness and safety of the EV ICD system in patients who are at risk of sudden cardiac death.
In the study, 356 patients were enrolled at 46 locations across 17 countries in the Middle East, North America, Asia, Australia, Europe, and New Zealand.
The EV ICD system demonstrated 98.7% effectiveness in delivering defibrillation therapy, which exceeds the pre-specified performance goal of 88%, in the study.
The company stated that the results indicate superior defibrillation efficacy for the EV ICD, compared to historical transvenous ICD studies.
It also noted that the system has successfully treated all discrete spontaneous arrhythmias.
Additionally, the trial exceeded its safety endpoint of 92.6% of patients attaining relief from major system, or procedure-related complications at six months.
Medtronic Cardiac Rhythm Management business chief medical officer Alan Cheng said: “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.
“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.”
Furthermore, the company has received approval from the Food and Drug Administration (FDA) for a continued access study, while the agency reviews its pre-market application for EV ICD.
Recently, Medtronic has reported an 8% decrease in global revenue for the first quarter of the fiscal year 2023 to $7.371bn.