Aurora EV-ICD™ system
for VENTRICULAR TACHYARRHYTHMIA management
The Aurora EV-ICD™ system is a first-of-its-kind extravascular defibrillator to treat abnormal heart rhythms with defibrillation and antitachycardia pacing (ATP).
The Aurora EV-ICD system is approved for 1.5T and 3T MRI access when MR conditions for use are met.
Model #: DVEA3E4, EV2401 – 52 cm, 63 cm
Overview
Product features
The extravascular system with transvenous ICD benefits.1
The Aurora EV-ICD system is the only ICD placed outside the vascular space that provides ATP in a device that is nearly half the size and has 60% greater projected battery longevity than the S‑ICD.2,3
- Avoids certain complications associated with transvenous leads.†
- Preserves the vasculature and reduces the potential for injury.†
ATP
The only extravascular ICD to offer ATP.2
In the EV ICD Pivotal Clinical Study, ATP successfully terminated 70% of episodes (32 of 46).1 This is in the range of the ATP efficacy reported in transvenous ICD publications, 52% to 87%.4–7
Clinical evidence
Medtronic EV ICD Pivotal Study‡1
Effectively terminated life-threatening rhythms with ATP and shocks while safely outside the vascular space.
Safe procedure
Primary safety objective met, 92.6% patients free from major system– or procedure–related complications at six months.§
Effective defibrillation
Primary efficacy objective met, 98.7% defibrillation success rate at implant,100% conversion of discrete spontaneous episodes.II
Successful ATP
70% of episodes successfully terminated, avoiding 33 shocks in seven patients9 (through 10.6 months average follow-up).
System safety
- No major intraprocedural or unique major complications due to the EV ICD system.
- No reports of mediastinitis, sepsis, or endocarditis related to the EV ICD system.
- The study’s investigators observed 25 major complications in 23 patients at six months. Procedure-related complications included revision for lead dislodgement and treatment of postoperative wound infection. No system changes were required for seven events.
Product information
Specifications
| Physical characteristics |
|
|---|---|
| Volumea |
33 cm3 |
| H x W x D |
64 mm x 51 mm x 13 mm |
| Surface area of device can |
57 cm2 |
| Connector type |
EV4-LLHH |
| Length |
30 mm |
| Functional diameter |
3.2 mm |
| Radiopaque IDb |
REX |
| Materials in contact with human tissuec |
Titanium, polyurethane, silicone rubber adhesive, silicone rubber, liquid silicone rubber |
| Battery |
Hybrid CFx lithium/silver vanadium oxide |
| Battery model |
M970710A |
| a Volume with connector ports unplugged. b The radiopaque ID, which includes a Medtronic identifier symbol, can be viewed in a fluoroscopic image of the device. c These materials have been successfully tested for the ability to avoid biological incompatibility. The device does not produce an injurious temperature in the surrounding tissue during normal operation. |
|
| Replacement indications |
|
|---|---|
| Recommended replacement time (RRT) |
< 2.73 V on 3 consecutive daily automatic measurements |
| End of service (EOS) |
3 months after RRT |
| Projected service life |
|---|
| The service life projection for the device is 11.7 years. |
| Based on the following assumptions: • Pacing at 0%. • 2 high-voltage therapies per year. • Pre-arrhythmia EGM storage programmed to On for 6 months, over life of device. • Wireless telemetry: – 3 hours of telemetry enabled at implant. – 30 min of telemetry enabled for quarterly scheduled CareLink™ monitor remote sessions (if available). – 1 hour of in-office wireless telemetry enabled annually. • Shelf storage life of 5 months, before implant. |
Ordering information
| Product |
Description |
Model number |
|---|---|---|
| Aurora EV-ICD™ MRI SureScan™ |
Extravascular implantable cardiovascular defibrillator |
DVEA3E4 |
| Epsila EV™ MRI SureScan |
Extravascular quadripolar lead with shaped passive fixation |
EV2401 – 52 cm |
| EV2401 – 63 cm |
||
| Epsila EV™ |
Sternal tunneling tool |
EAZ101 |
| Epsila EV™ |
Transverse tunneling tool |
EAZ201 |
| SafeSheath®* II |
Hemostatic peel-away introducer system |
SSCL9 |
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*
™Third-party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company.
†
The Aurora EV-ICD lead is not intended for implantation within the heart or vasculature, and, thus, Aurora is expected to avoid vascular complications associated with transvenous leads. There were no major intraprocedural complications observed in the EV ICD Pivotal clinical study.1
‡
Through an average 10.6-month follow-up.
§
Kaplan-Meier estimate.
||
Discrete episodes are defined as less than or equal to two events within 24 hours.
References
1
Friedman P, Murgatroyd F, Boersma LVA, et al. Efficacy and Safety of an Extravascular Implantable Cardioverter-Defibrillator. N Engl J Med. October 6, 2022;387(14):1292–1302.
2
Medtronic Aurora EV-ICD™ MRI SureScan™ DVEA3E4 Device Manual.
3
Emblem MRI S-ICD technical manual. Boston Scientific. Available at: bostonscientific.com/content/dam/elabeling/crm/92346911-002_EMBLEM_UM_en_S.pdf. Accessed August 28, 2023.
4
Sterns LD, Auricchio A, Schloss EJ, et al. Anti-tachycardia pacing success in implantable cardioverter defibrillators by patient, device, and programming characteristics. Heart Rhythm. October 19, 2022;20(2): P190–197.
5
Schuger C, Daubert JP, Zareba W, et al. Reassessing the role of antitachycardia pacing in fast ventricular arrhythmias in primary prevention implantable cardioverter-defibrillator recipients: Results from MADIT-RIT. Heart Rhythm. March 2021;18(3):399–403.
6
Arenal A, Proclemer A, Kloppe A, et al. Different impact of long-detection interval and anti-tachycardia pacing in reducing unnecessary shocks: data from the ADVANCE III trial. Europace. November 2016;18(11):1719–1725.
7
Lee, S., Stern, R., Wathen, M., et al. Anti-Tachycardia Pacing Therapy Effectively Terminates Fast Ventricular Tachycardia after Longer Detection Duration in Primary Prevention Patients: Results from the PREPARE Trial. Heart Rhythm. May 2008;5(5); S334-S356. Poster PO5–103.
8
Boriani G, Merino J, Wright DJ, Gadler F, Schaer B, Landolina M. Battery longevity of implantable cardioverter-defibrillators and cardiac resynchronization therapy defibrillators: technical, clinical and economic aspects. An expert review paper from EHRA. Europace. December 1, 2018;20(12):1882–1897.
9
Crozier I, et al. Primary Outcome Results from the Global Extravascular Implantable Cardioverter Defibrillator (EV ICD) Pivotal Study. Late Breaking Clinical Trial Presentation at ESC 2022. August 28, 2022. Barcelona Spain.