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Aurora

Aurora EV-ICD™

for tachyarrhythmia management

Aurora EV-ICD offers the advantages of an extravascular system while also providing ATP and Pause Prevention pacing in a device the same size as transvenous ICDs.

Model #: DVEA3E4

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Aurora EV-ICD MRI SureScan
Alert Indications, Safety, and Warnings

Overview

Aurora EV-ICD, the extravascular system with transvenous ICD benefits.

Product details

Extravascular advantages

Aurora offers the advantages of an extravascular system1

  • Avoids certain complications associated with transvenous leads*
  • Preserves the vasculature and reduces potential for vascular injury

*The Aurora EV-ICD 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, as stated in Friedman P, et al. N Engl J Med. 2022;387:1292-1302.

Transvenous ICD features

Decorative element

The only available extravascular ICD to offer ATP — In the EV ICD Pivotal clinical study, ATP successfully terminated 70% of episodes (32 of 46), even with an extended detection interval (VF NID = 30/40).1 This is in the range of the ATP efficacy reported in transvenous ICD publications, 52% to 87%.2–5

Decorative element

Longevity 11.7 years — Projected longevity6 is similar to other Medtronic single chamber ICDs.7,8 Devices with a long device lifespan can reduce the number of replacements and associated procedure risks.

Decorative element

Pause Prevention — A pacing feature that monitors the heart for significant pauses and responds by providing temporary bradycardia pacing support.2–9

Decorative element

Size and PhysioCurve™ design — Minimizes tissue pressure and promotes patient comfort.9

Lead design

Epsila EV™ defibrillation lead key features:

  • Epsilon-shaped distal section is intended to optimize the electrodes’ locations relative to the heart and the device
    • Defibrillation coils positioned toward the patient’s right side for a wider defibrillation vector between the coils and the device
    • Pacing/sensing ring electrodes positioned toward the patient’s left side for closer proximity to the heart
    • Curvature intended to help stabilize the lead in the mediastinal tissue
  • Four electrodes, consisting of two coils and two rings, to support three different pacing vector options and three sensing vector options
  • Isodiametric 8.7 Fr lead body and four conductor cables extending to the distal tip of the lead to provide high tensile strength for extractability
Close-up anatomical illustration of a chest showing the location of the Aurora EV-ICD
  1. Coil 1 electrode (defibrillation) 
  2. Ring 1 electrode (sensing)
  3. Coil 2 electrode (defibrillation)
  4. Ring 2 electrode (sensing)
  5. Preformed bend
  6. Anchoring sleeve
  7. Blue insertion indicator
  8. Connector pin
Epsila EV lead with numbered callouts

Clinical evidence

Medtronic EV-ICD™ Pivotal Study1

  • Primary safety objective met: 92.6% patients free from major system or procedure-related complications at 6 months.
  • Successful defibrillation: 98.7% defibrillation success rate at implant meeting primary efficacy objective. 18/18 (100%) conversion of spontaneous episodes.
  • ATP efficacy: 70%* ATP-terminated episode success rate, avoiding 33 shocks in 7 patients.
  • No major intraprocedural or unique complications due to the EV-ICD system
  • No reports of medastinitis, sepsis, or endocararditis related to the EV-ICD system
View clinical evidence

Procedure

New, custom implant tools and techniques were developed to help ensure the safety of the procedure and the performance of the system.

Epsila EV™ sternal tunneling tool

Model EAZ101

Epsila EV sternal tunneling tool with numbered callouts
  1. Handle
  2. Thumb tab
    • Used to raise and lower the external guide
  3. External guide (removable)
    • Hinged and removable to accommodate physician preference and patient anatomy
    • Remains above the skin and indicates the distance and direction of the tunneling rod
  4. Preformed bend
    • Facilitates contact with the posterior side of the sternum
  5. Stainless steel tunneling rod
    • Delivers an introducer to the anterior mediastinum

Epsila EV™ transverse tunneling tool

Model EAZ201

Epsila EV transverse tunneling tool with numbered callouts

Flexible tunneling rod for tracking across the chest

  1. Handle
  2. Tunneling rod

Use of a 9 Fr diameter, 19.13 cm long lead introducer is recommended for use with the Epsila EV sternal tunneling tool Model EAZ101.10 For example, the SafeSheath II Model SSCL9 may be used.

SafeSheath® II hemostatic peel-away introducer system

Model SSCL9

  • 9 Fr diameter
  • Custom 19.13 cm length to fit with the exclusive Epsila EV sternal tunneling tool10
SafeSheath II hemostatic peel-away introducer System on white background

Videos

Model specifications

pdf Aurora Device Spec Sheet (FIGS) (.pdf)

217KB

pdf Epsila EV Lead Spec Sheet (FIGS) (.pdf)

327KB

pdf Sternal Tunneling Tool Spec Sheet (FIGS) (.pdf)

175KB

pdf Transverse Tunneling Tool Spec Sheet (FIGS) (.pdf)

131KB

Related pages

Educational resources on Medtronic Academy

Access interactive courses, videos, and educational resources to extend your learning on Aurora.

Visit Medtronic Academy
*

67% of episodes successfully treated with ATP at 18 months (35/52 episodes)

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

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.

3

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.

4

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. 2008;5(5);S334-S356.

5

Sterns LD, Auricchio A, Schloss EJ, et al. Anti-tachycardia pacing success in implantable cardioverter defibrillators by patient, device, and programming characteristics. Heart Rhythm. February 2023;20(2):P190–P197.

6

Medtronic Aurora EV-ICD™ MRI SureScan™ DVEA3E4 device manual.

7

Medtronic Visia AF MRI™ VR SureScan™ DVFB2D4 Device Manual M980310A001 A. Available at: https://manuals.medtronic.com/content/dam/emanuals/crdm/M980310A001A_view.pdf. Accessed February 5, 2022.

8

Medtronic Cobalt™ XT VR ICD MRI SureScan™ Model DVPA2D4 device manual. Available at: https://manuals.medtronic.com/content/dam/emanuals/crdm/M975366A001C_view.pdf. Accessed December 5, 2022.

9

Mathiesen D, Bhatia V, Formosa E, et al. Prediction of Patient Comfort for Extravascular and Subcutaneous Implantable Cardioverter-Defibrillation Devices Using Modeling. AHA Abstract 13385. Circulation. November 8, 2021;144:A13385.

10

Medtronic Epsila EV™ sternal tunneling tool Model EAZ101 technical manual.