Implantable cardioverter defibrillators

Aurora EV-ICD™ system

Implantable cardioverter defibrillators

Aurora EV-ICD™ system

The Aurora EV-ICD™ system is used to treat sudden cardiac arrest and abnormal heart rhythms with defibrillation and antitachycardia pacing (ATP).

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Indications, Safety, and Warnings

Description

The extravascular system with transvenous ICD benefits1

The Aurora EV-ICD™ system is a first-of-its-kind extravascular defibrillator to treat sudden cardiac arrest and abnormal heart rhythms with defibrillation and ATP in a single device.

The Aurora EV-ICD™ system is the only ICD placed outside the vascular space that provides ATP in a single device that is nearly half the size and has 60% greater projected battery longevity than the subcutaneous implantable cardioverter defibrillator (S-ICD).†,2,3

The Aurora EV-ICD™ system:

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

Features

Learn about:

   

Extravascular implant location

The only extravascular ICD to offer ATP

In the EV ICD Pivotal Clinical Study, ATP successfully terminated 77% of episodes (37/48), long-term results.§,4 This is in the range of the ATP efficacy reported in transvenous ICD publications, 52% to 87%.5–8

Size and PhysioCurve™ design

The Aurora EV-ICD™ system offers a small size (33 mL) and PhysioCurve™ design — same size and shape as Medtronic transvenous single-chamber ICDs.2

Projected longevity

The Aurora EV-ICD™ system has 11.7 years projected longevity,2 which is similar to other Medtronic single-chamber ICDs. Greater device longevity may result in fewer device replacements, fewer associated procedure risks, and lower total product costs.9

Projected battery longevity estimates are based on accelerated battery discharge data and device modeling. Results for individual patients vary based on programmed parameters and features. 

Pause prevention pacing

Pause prevention pacing is a pacing feature that monitors the heart for significant pauses and responds by providing temporary bradycardia pacing support.2

Post-shock pacing

The Aurora EV-ICD™ system can deliver temporary post-shock pacing following a defibrillation or cardioversion therapy, as there may be a temporary bradycardia or asystole after the heart receives a high-voltage therapy.2

Monitor zone

The Aurora EV-ICD™ system has a ventricular tachycardia (VT) monitor zone that allows for documentation of slow VTs, including non-sustained VTs.2

Remote monitoring and CareAlert™ notifications

Alerts can be delivered by the device tone and by the patient’s home monitor.2

MRI access

The Aurora EV-ICD™ system offers 1.5T and 3T MRI access when MR conditions for use are met.2

Clinical evidence

Enlighten: The Aurora EV-ICD™ system’s Post-Approval Registry

The Enlighten Study is an ongoing global, prospective, observational, multisite registry study.10 This first report of 228 enrolled patients found that the Aurora EV-ICD™ system’s real-world periprocedural performance is consistent with the premarket experience.11

High implant success

96.9% implant success rate◊
 

High defibrillation testing success

99.0% of patients had effective defibrillation of induced episodes at implant.

Low complication rate

3.9% rate of system- or procedure-related major complications through hospital discharge

Read the manuscript (open in new window)

Medtronic EV ICD Pivotal Study

Primary results¶,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 episodesΔ

Successful ATP

70% of episodes successfully terminated, avoiding 33 shocks in seven patients¶,10 
 

Read the manuscript (open in new window)
Long-term results§,∞,4

EV-ICD demonstrated high ATP success and effective defibrillation in a single device while safely outside the vascular space.
 

Successful ATP with 77% of episodes terminated§

Shock was avoided in nearly half of all VT/VF episodes because of the availability of ATP.§

  • ATP use increased significantly through the duration of follow-up
    (p < 0.0001).††
  • No patient with successful ATP had therapy programmed off subsequently.
     
Safe procedure, safe system∞
  • No major intraprocedural complications
  • No unique complications observed related to the EV-ICD procedure or system
  • No reports of mediastinitis, sepsis, or endocarditis related to EV-ICD
  • Thirty-one system- or procedure-related major complications occurred in 29 patients throughout the study. Of these, the most common were revision for lead dislodgement and treatment for postoperative wound or pocket infection.
Access the manuscript (open in new window)

Shock treated
44 episodes

This is a dark and electric blue pie chart depicting 44 and 38 percent.

ATP treated and
shock avoided in
38 episodes

Specifications

The Epsila EV™ MRI SureScan™ defibrillation lead is an MR Conditional lead approved for use when an extravascular implantable cardioverter defibrillator is indicated to treat tachycardia.
 

The epsilon-shaped distal section is intended to optimize the electrodes’ locations relative to the heart and the device.

  1. Defibrillation coils positioned toward the patient’s right side for a wider defibrillation vector between the coils and the device. 
  2. Pacing/sensing ring electrodes positioned toward the patient’s left side so they are closer to the heart.

 

This is an image of the entire Epsila EV™ MRI SureScan™ defibrillator lead with numbered callouts.
  • Curvature intended to help stabilize the lead in the mediastinal tissue
  • Four electrodes, consisting of two coils and two rings, support three different pacing vector options and three sensing vector options
  • Isodiametric 8.7 Fr lead body and four conductor cables extend to the distal tip of the lead to provide high tensile strength for extractability

Epsila EV™ sternal tunneling tool12

The Epsila EV™ sternal tunneling tool is designed to deliver an introducer to place an extravascular lead into the anterior mediastinum during implant of an extravascular implantable device system.
 

  1. Handle
  2. Thumb tab
  3. Stainless steel tunneling rod 
  4. External guide (removable)
This is an image of the entire Epsila EV™ sternal tunneling tool with numbered callouts.

SafeSheath®* II hemostatic peel-away introducer system13

The SafeSheath®* II hemostatic peel-away introducer system is a specialized implant tool for the Aurora EV-ICD™ system that is used with the Epsila EV™ sternal tunneling tool. The SafeSheath®* II hemostatic peel-away introducer system is packaged and sold separately.
 

  • 9 Fr diameter
  • 19.13 cm length to fit with the Epsila EV™ sternal tunneling tool
This is an image of the SafeSheath®* II hemostatic peel-away introducer system.

Epsila EV™ transverse tunneling tool14

The Epsila EV™ transverse tunneling tool is designed to deliver the proximal portion of an extravascular lead to the device pocket during implant of an extravascular implantable device system.
 

  1. Handle
  2. Channel for lead delivery
  3. Tunneling rod
This is an image of the entire Epsila EV™ transverse tunneling tool with numbered callouts.

Ordering information

Item number Product Description
DVEA3E4 Aurora EV-ICD™ MRI SureScan™ Extravascular implantable cardiovascular defibrillator
EV240152 Epsila EV™ MRI SureScan™ Extravascular quadripolar lead with shaped passive fixation – 52 cm
EV240163 Epsila EV™ MRI SureScan™ Extravascular quadripolar lead with shaped passive fixation – 63 cm
EAZ101 Epsila EV™ Sternal tunneling tool
EAZ201 Epsila EV™ Transverse tunneling tool
SSCL9 SafeSheath®* II Hemostatic peel-away introducer system

 

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®* Third-party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company.

† Projected battery longevities are as reported in the approved device labeling.2,3

‡ The Aurora EV-ICD™ lead is not intended for implantation within the heart or vasculature, and, thus, Aurora EV-ICD™ lead 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​

§ Follow-up duration is an average of 30.6 months for the n = 299 patients with a successful implant.​

◊ Implant success is a patient proceeding from implant to follow-up with an implanted device.

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.​

∞ Follow-up duration is an average of 29.0 months for the n = 316 patients with an implant attempt.​

†† Based on a paired statistical test comparing pre-hospital discharge to last available follow-up.​

  1. Friedman P, Murgatroyd F, Boersma LVA, et al. Efficacy and safety of an extravascular implantable cardioverter-defibrillator. N Engl J Med. 2022;387(14):1292–1302. doi: 10.1056/NEJMoa2206485.
  2. Medtronic Aurora EV-ICD™ MRI SureScan™ DVEA3E4 implant manual. M991372A001 REV. E. Medtronic; 2013.
  3. Emblem™* MRI S-ICD technical manual. Boston Scientific. Accessed August 28, 2023.

  1. Murgatroyd F, Friedman P, Manlucu J, et al. Consistent ATP, defibrillation, and safety performance of the extravascular ICD: Final results from the global EV-ICD Pivotal Trial. Oral presentation: ESC 2024; August 30–September 2, 2024; London, England.
  2. Sterns LD, Auricchio A, Schloss EJ, et al. Anti-tachycardia pacing success in implantable cardioverter defibrillators by patient, device, and programming characteristics. Heart Rhythm. 2022;20(2): P190–197. doi: 10.1111/pace.13980.
  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. 2021;18(3):399–403. doi: 10.1016/j.hrthm.2020.11.019.
  4. 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. 2016;18(11):1719–1725. doi: 10.1093/europace/euw032.
  5. 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. Poster PO5–103. Heart Rhythm. 2008;5(5); S334-S356. doi: 10.1016/j.hrthm.2022.10.015.
  6. 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. 2018;20(12):1882–1897. doi: 10.1093/europace/euy066.
  7. Boersma LVA, Amin A, Clémenty N, et al. Design of a post-market registry for the extravascular implantable cardioverter-defibrillator: the Enlighten Study. Heart Rhythm O2. 2025;6(1):64–69. doi: 10.1016/j.hroo.2024.09.022.
  8. Crozier I, Murgatroyd F, Amin A, et al. Periprocedural outcomes from the post-market study of the extravascular implantable cardioverter-defibrillator: Preliminary Enlighten Study results and meta-analysis. Heart Rhythm. 2008;5(5):S334-S356.
  9. Crozier I. Primary outcome results from the global extravascular implantable cardioverter defibrillator (EV ICD) pivotal study. Presented at: ESC 2022; August 28, 2022; Barcelona Spain.
  10. Haqqani H, Denman R, Prabhu A, Thompson A, Marshall M, Portway B, Crozier I. Chronic ICD lead removal from the substernal space is feasible without complication. Circulation. 144:A13966. doi:10.1161/circ.144.suppl_1.13966.
  11. Medtronic Epsila EV™ sternal tunneling tool Model EAZ101 technical manual. M999188A001 REV. D. Medtronic; 2023.
  12. Pressure Products SafeSheath II Hemostatic Tear-away Introducer System with Infusion Side Port instructions for use. 00SSII-MED/01 Pressure Products Medical Supplies, Inc.; March, 2016.
  13. Medtronic Epsila EV™ transverse tunneling tool Model EAZ201 technical manual. M999195A001 REV. D. Medtronic; 2023.