This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: Aurora Extravascular Implantable Cardioverter Defibrillator (EV-ICD) System
PMA Applicant: Medtronic Inc.
Address: 8200 Coral Sea Street, Mounds View, MN 55112
Approval Date: October 20, 2023
Approval Letter: Approval Order
What is it?
The Aurora EV-ICD System is used together to monitor the heart and provide therapy for life-threatening arrhythmias. The System is comprised of the Aurora EV-ICD MRI SureScan Model DVEA3E4 extravascular implantable cardioverter defibrillator (ICD) and the Epsila EV MRI SureScan Model EV2401 extravascular lead. The Aurora EV-ICD MRI SureScan single chamber ICD is a multiprogrammable cardiac device. The Epsila EV lead is a shaped, passive fixation, extravascular quadripolar lead.
How does it work?
The Aurora EV-ICD device is implanted into a surgical pocket on the patient’s left side underneath the skin and connected to the lead. A doctor then ensures that the lead can adequately sense the heartbeat and provide appropriate therapy to the heart. The doctor can program the Aurora EV-ICD system for personalized therapy.
When is it used?
A doctor uses the Aurora EV-ICD System to treat patients who have experienced or are at significant risk of developing life-threatening ventricular tachycardia (VT).
What will it accomplish?
In a clinical study, doctors implanted the Aurora EV-ICD System in 299 patients. The study showed that the Aurora EV-ICD System using a substernal (underneath the sternum) lead is effective at terminating ventricular arrhythmias (abnormal heartbeats that occur in the lower heart chambers, called ventricles), as demonstrated by effective defibrillation at implant in 98.7% of patients.
When should it not be used?
The device should not be used in patients with the following conditions:
- If persistent VT or ventricular fibrillation (VF) exists
- If the patient’s primary disorder is chronic atrial tachyarrhythmia (abnormally fast heart rhythm occurring in the upper heart chambers, called atria) with no concurrent VT or VF
- If symptomatic bradycardia (slow heart rate) exists
- If tachyarrhythmias with transient or reversible causes exist.
Additional information (including warnings, precautions, and adverse events):
- Summary of Safety and Effectiveness Data (SSED)
- Labeling - Device Manual
- Labeling 2 - Patient Manual