Medtronic has obtained CE mark for its Aurora EV-ICD MRI SureScan (Extravascular Implantable Cardioverter-Defibrillator) and Epsila EV MRI SureScan defibrillation lead for treating abnormal heart rhythms.
The Aurora EV-ICD system, which is investigational in the US, has been designed to treat severe fast heart rhythms, which can lead to sudden cardiac arrest (SCA).
It is indicated for people who are at risk of life-threatening arrhythmias, who have not received prior sternotomy and who do not require chronic bradycardia (abnormally slow heartbeat) pacing.
The system offers the same benefits as traditional implantable cardioverter-defibrillators (ICDs).
It also avoids certain risks, as the EV-ICD system’s lead (thin wire) is placed outside the heart and veins.
Medtronic Cardiovascular Portfolio 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.”
The company stated that ICDs are effective in treating patients who are at risk of SCA, which is caused by a dangerously fast heart rate (ventricular tachycardia).
Traditional ICDs are implanted in the chest and attached to leads to deliver therapy that terminates potentially fatal arrhythmia and restores normal heart rhythm.
Medtronic’s Aurora EV-ICD system is implanted below the left armpit, and the Epsila EV lead is placed under the sternum through a minimally invasive approach.
The placement of the leads outside the heart and veins is expected to eliminate long-term complications related to transvenous leads.
The system was evaluated in the Extravascular Implantable Cardioverter Defibrillator (EV ICD) study, which met its safety and effectiveness endpoints.
Medtronic intends to commercialise the Aurora EV-ICD system in select European countries later in the year.