The EV ICD system is designed to treat dangerously fast heart rhythms that can lead to sudden cardiac arrest (SCA), while avoiding certain risks related to traditional, transvenous ICDs, said Medtronic
Medtronic defibrillator shows superior effectiveness in study. (Credit: Ignacio DG from Pixabay)
Global healthcare technology firm Medtronic announced that its investigational defibrillator system showed 98.7% success rate and met safety endpoints in an international clinical trial.
The Extravascular Implantable Cardioverter Defibrillator (EV ICD) System is designed to treat dangerously fast heart rhythms that can lead to sudden cardiac arrest (SCA).
It is said to avoid certain long-term complications, such as vessel occlusion and blood infection risks, as its lead is placed outside the heart and veins, under the breastbone.
The lead of the EV ICD system is connected to a device, which will be implanted below the left armpit, in the left mid-axillary region.
The EV ICD study is a multicentre, non-randomised, pre-market study that evaluated the safety and effectiveness of the EV ICD system in patients at risk of sudden cardiac death.
It enrolled 356 patients at 46 sites across 17 countries in North America, Europe, the Middle East, Asia, Australia and New Zealand.
In the study, the device showed 98.7% effectiveness in delivering defibrillation therapy, which exceeds the pre-specified performance goal of 88%.
The results indicate superior defibrillation efficacy for the EV ICD, compared to historical transvenous ICD studies, comparable efficacy to the subcutaneous ICD.
In addition, the system successfully treated all discrete spontaneous arrhythmias, said Medtronic.
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.”
The study also exceeded its safety endpoint of 92.6% of patients experiencing relief from major system, or procedure-related complications, at six months.
No major intraprocedural complications, or any unique complications were observed related to the EV ICD procedure or system, compared to transvenous and subcutaneous ICDs, said Medtronic.
Furthermore, the company has received FDA approval for a continued access study, while the agency reviews its pre-market application for EV ICD.