The Aurora EV-ICD MRI SureScan defibrillator and Epsila EV MRI SureScan defibrillation lead are approved for investigational use in US patients, who are at risk of life-threatening arrhythmias
Medtronic gets CE mark for Aurora EV-ICD system. (Credit: jesse orrico on Unsplash)
Medtronic has received CE mark approval for its extravascular implantable cardioverter-defibrillator system to treat severe fast heart rhythms that can lead to sudden cardiac arrest.
The system, which includes Aurora EV-ICD MRI SureScan defibrillator and Epsila EV MRI SureScan defibrillation lead, is approved for investigational use in the US.
The system is indicated for patients who are at risk of life-threatening arrhythmias, who previously not received prior sternotomy and who do not need chronic bradycardia pacing.
It provides the same benefits as traditional Implantable cardioverter-defibrillators (ICDs), while eliminating certain risks, as its lead is placed outside the heart and veins, said Medtronic.
The system is planned to be commercialised in select European countries later this year.
Medtronic cardiac rhythm management business chief medical officer Alan Cheng said: “We are proud to be the first company to offer a complete one-system, one-procedure extravascular ICD solution, which maintains the patient benefits of traditional, transvenous ICDs without the risk of leads in the heart and vasculature.
“This approval is a significant milestone in achieving our goal of delivering a defibrillation solution that treats sudden cardiac arrest while improving the patient experience.”
According to Medtronic, ICDs are effective in treating patients at risk of sudden cardiac arrest (SCA), due to dangerously fast heart rate (ventricular tachycardia).
Traditional ICDs are implanted in the chest and attached to leads to deliver therapy to terminate a potentially fatal arrhythmia and restore the heart’s normal rhythm.
Medtronic claims that its Aurora EV-ICD system is similar in size, shape, and longevity compared to traditional ICDs.
It provides patients with defibrillation, anti-tachycardia pacing (ATP), and backup pacing therapies, through a single implanted device.
The Aurora EV-ICD system is implanted below the left armpit and the Epsila EV lead is placed under the sternum, using a minimally invasive approach.
The placement of lead outside of the heart and veins is expected to eliminate the long-term complications related to transvenous leads.
The CE mark approval is based on results from the Extravascular Implantable Cardioverter Defibrillator (EV ICD) study, which met its safety and effectiveness endpoints.