Implantable cardioverter defibrillators

Aurora EV-ICD™ system

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

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Indications, Safety, and WarningsIndicationsDeviceThe Aurora EV-ICD™ MRI SureScan™ Model DVEA3E4 device is indicated for the automated treatment of patients who have experienced, or are at significant risk of developing, life-threatening ventricular tachyarrhythmias through the delivery of antitachycardia pacing, cardioversion, and defibrillation therapies. Medical conditions that may indicate a patient for an EV-ICD for primary or secondary prevention of sudden cardiac death due to life-threatening ventricular tachyarrhythmias include previous ventricular tachyarrhythmias, coronary disease with left ventricular dysfunction, cardiomyopathy, inherited primary arrhythmia syndromes, and congenital heart disease.Note: For patient-specific recommendations regarding indications for primary and secondary prevention of sudden cardiac death, refer to current clinical guidelines from the European Society of Cardiology (ESC), American Heart Association (AHA), American College of Cardiology (ACC), and Heart Rhythm Society (HRS).Lead The Epsila EV™ MRI SureScan™ Model EV2401 extravascular lead is indicated for use in the anterior mediastinum for pacing therapies, cardioversion, and defibrillation when an extravascular implantable cardioverter defibrillator is indicated to treat patients who have experienced, or are at significant risk of developing, life-threatening ventricular tachyarrhythmias.Tunneling toolsThe Epsila EV™ Model EAZ101 sternal tunneling tool is indicated for use in the implant of a compatible anterior mediastinum defibrillation lead.The Epsila EV™ Model EAZ201 transverse tunneling tool is indicated for use in the implant of a compatible anterior mediastinum defibrillation lead.MR conditions for useThe Aurora EV-ICD™ MRI SureScan™ system is MR Conditional and, as such, is designed to allow patients to be safely scanned by an MRI machine when used according to the specified MR conditions for use. A complete SureScan™ system is required for use in the MR environment. Before performing an MR scan, refer to the MRI technical manual for MRI-specific warnings and precautions. When programmed to on the MRI SureScan™ feature allows the patient to be safely scanned. A complete SureScan™ system includes a SureScan™ extravascular ICD device (Model DVEA3E4) with a SureScan™ extravascular lead (Model EV2401). Any other combination may result in a hazard to the patient during an MRI scan.ContraindicationsThe Aurora EV-ICD™ MRI SureScan™ Model DVEA3E4 device is contraindicated for use in the following situations:

If implanted with a unipolar pacemaker, a device delivering dual-chamber or triple-chamber pacing, and/or a device delivering antitachyarrhythmia therapies

If incessant ventricular tachycardia (VT) or ventricular fibrillation (VF) exists

If the patient’s primary disorder is chronic atrial tachyarrhythmia with no concomitant VT or VF

If symptomatic bradycardia exists

If tachyarrhythmias with transient or reversible causes exist

The Epsila EV™ MRI SureScan™ Model EV2401 lead is contraindicated for any application that is not specified in the indications.The Epsila EV™ Model EAZ101 sternal tunneling tool is contraindicated for use in patients with a prior sternotomy.The Epsila EV™ Model EAZ201 transverse tunneling tool is contraindicated for any application that is not specified in the indications.Warnings and precautionsDevice and leadIt is important to read the Aurora EV-ICD™ MRI technical manual before conducting an MRI scan on a patient with an implanted SureScan™ system. The MRI SureScan™ feature permits a mode of operation that allows a patient with a SureScan™ system to be safely scanned by an MRI machine. When programmed to on, MRI SureScan™ operation disables arrhythmia detection and all user-defined diagnostics. Do not scan a patient without first programming the MRI SureScan™ mode to on. Scanning the patient without programming the MRI SureScan™ mode on may result in patient harm or damage to the SureScan™ system.Patients and their implanted systems must be screened to meet the following requirements for MRI: no implanted lead extenders, lead adaptors or abandoned leads present; no broken leads or leads with intermittent electrical contact as confirmed by lead impedance history; and the SureScan™ device must be operating within the projected service life; the device does not provide pacing therapy when SureScan™ mode is programmed on. Do not scan pacemaker-dependent patients. MRI scans during the lead maturation period have not been prospectively studied by Medtronic and are not recommended. If scanning a patient with multiple devices, ensure all devices meet the MRI labeling conditions.Use only the Epsila EV™ MRI SureScan™ Model EV2401 extravascular lead with a Medtronic EV4 implantable cardioverter defibrillator system. The known potential adverse consequences of using any other combination may include undersensing of cardiac activity, failure to deliver necessary therapy, or an intermittent electrical connection. All can present serious risks for adverse events to the patient. The EV4 connector is a Medtronic proprietary design, not an industry standard. No claims of safety and efficacy can be made with regard to devices that are not labeled as EV4 by Medtronic.Pre-implant consideration for concomitant implant with a neurostimulator and cardiac device implants: Some patients have medical conditions that require the implant of both a neurostimulator and a cardiac device (for example, a pacemaker, a defibrillator, or a monitor). In this case, physicians involved with either device should contact Medtronic Technical Services or their Medtronic representative before implanting the patient with the second device. Based on the particular devices that the physicians have prescribed, Medtronic can provide the necessary precautions and warnings related to the implant procedure.Use of the DVEA3E4 device has not been evaluated in patients who have undergone a prior sternotomy.The DVEA3E4 device has not been tested specifically for pediatric use.Use of the EV2401 lead has not been evaluated in patients who have undergone a prior sternotomy. Performing a sternotomy on a patient with an implanted lead has not been evaluated. Do not implant the EV2401 lead using any tools other than the Medtronic tunneling tools designed for implanting the extravascular ICD system. Tunneling toolsThe tunneling tools have not been tested for use with non-Medtronic products or for pediatric use. Use of the EAZ201 transverse tunneling tool have not been evaluated in patients who have undergone a prior sternotomy.Potential adverse eventsImplant and usage of this system may result in adverse events, which may lead to injury, death, or other serious adverse reactions. Potential adverse events include, but are not limited to acute tissue trauma, allergic reaction, bradyarrhythmia, cardiac arrest, cardiac inflammation, cardiac perforation, cardiac tamponade, death, device migration, discomfort, dizziness, dyspnea, erosion, extracardiac stimulation, fever, hematoma, hemorrhage, hemothorax, hiccups, hospitalization, inappropriate shock, infection, insulation failure, lead abrasion, lead fracture, lead migration or dislodgement, lethargy, mental anguish, organ damage (liver, mammary arteries, diaphragmatic arteries), pain, palpitations, pericardial effusion, pericarditis, pneumothorax, return of cardiac symptoms, seroma, syncope, tachyarrhythmia, toxic reaction, and wound dehiscence.Potential MRI adverse events include the following: lead electrode heating resulting in tissue damage near the lead electrodes or patient discomfort or both; spontaneous tachyarrhythmia occurring during the scan that is not detected and treated because tachyarrhythmia detection is suspended while MRI SureScan™ mode is programmed to on; device heating resulting in tissue damage in the implant pocket or patient discomfort or both; MR-induced muscle stimulation resulting in patient discomfort; damage to the device or lead causing the system to fail to detect or treat irregular heartbeats or causing the system to treat the patient’s condition incorrectly; damage to the functionality or mechanical integrity of the device resulting in the inability of the device to communicate with the programmer; and movement or vibration of the device or leads resulting in dislodgment.See the Aurora EV-ICD™ MRI SureScan™ technical manual before performing an MRI Scan, and the device, lead and tunneling tools manuals for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events.  Refer to the Medtronic manual library. For further information, please call Medtronic at 1-800-328-2518 and/or consult the Medtronic website.Caution: Federal law (United States) restricts these devices to sale by or on the order of a physician.MIN_84266

Features

Learn about:

Clinical evidence
Specifications

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 — the 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 Real-world six-month results demonstrated that the Aurora EV-ICD™ system had high ATP success and effective defibrillation in a single device while safely outside the vascular space¹¹ (756 patients with a successful implant with average follow-up of 7.9 months).

High ATP success¹¹

67% ATP success rate,^◊ in line with transvenous ICDs^5–8 and consistent with EV ICD Pivotal Study performance¹
Shock was avoided in 44 episodes and 17 patients due to the availability of ATP
No patient had ATP programmed Off after receiving ambulatory ATP therapy

If implanted with a unipolar pacemaker, a device delivering dual-chamber or triple-chamber pacing, and/or a device delivering antitachyarrhythmia therapies

If incessant ventricular tachycardia (VT) or ventricular fibrillation (VF) exists

If the patient’s primary disorder is chronic atrial tachyarrhythmia with no concomitant VT or VF

If symptomatic bradycardia exists

If tachyarrhythmias with transient or reversible causes exist

Safe, low risk of complications¹¹

97.8% freedom from chronic system-related major complications^¶ at six months, in line with the EV ICD Pivotal Study six-month rate of 98.0%
No cases of mediastinitis, sepsis, or endocarditis related to Aurora EV-ICD™ system through most recent follow up

If implanted with a unipolar pacemaker, a device delivering dual-chamber or triple-chamber pacing, and/or a device delivering antitachyarrhythmia therapies

If incessant ventricular tachycardia (VT) or ventricular fibrillation (VF) exists

If the patient’s primary disorder is chronic atrial tachyarrhythmia with no concomitant VT or VF

If symptomatic bradycardia exists

If tachyarrhythmias with transient or reversible causes exist

Effective defibrillation¹¹

100% (47/47) defibrillation success of discrete^# spontaneous episodes through most recent follow-up
99% of patients had effective defibrillation of induced episodes at implant

If implanted with a unipolar pacemaker, a device delivering dual-chamber or triple-chamber pacing, and/or a device delivering antitachyarrhythmia therapies

If incessant ventricular tachycardia (VT) or ventricular fibrillation (VF) exists

If the patient’s primary disorder is chronic atrial tachyarrhythmia with no concomitant VT or VF

If symptomatic bradycardia exists

If tachyarrhythmias with transient or reversible causes exist

Inappropriate shock¹¹

A 5.5% rate of inappropriate shock at six months was observed.
The rate is 32% lower than what was observed in the EV ICD Pivotal Study (8.1% at six months⁴).
The proportion of inappropriate shocks due to P-wave oversensing decreased from 51% of episodes in the EV ICD Pivotal Study⁴ to 33% in Enlighten.¹¹
There are three strategies for mitigating inappropriate shock: lead positioning at implant, use of the Smart Sense algorithm, and device programming.

View APHRS late-breaking slides (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^∞

If implanted with a unipolar pacemaker, a device delivering dual-chamber or triple-chamber pacing, and/or a device delivering antitachyarrhythmia therapies

If incessant ventricular tachycardia (VT) or ventricular fibrillation (VF) exists

If the patient’s primary disorder is chronic atrial tachyarrhythmia with no concomitant VT or VF

If symptomatic bradycardia exists

If tachyarrhythmias with transient or reversible causes exist

Effective defibrillation

Primary efficacy objective met, 98.7% defibrillation success rate at implant,100% conversion of discrete spontaneous episodes^#

If implanted with a unipolar pacemaker, a device delivering dual-chamber or triple-chamber pacing, and/or a device delivering antitachyarrhythmia therapies

If incessant ventricular tachycardia (VT) or ventricular fibrillation (VF) exists

If the patient’s primary disorder is chronic atrial tachyarrhythmia with no concomitant VT or VF

If symptomatic bradycardia exists

If tachyarrhythmias with transient or reversible causes exist

Successful ATP

70% of episodes successfully terminated, avoiding 33 shocks in seven patients^∆,12

If implanted with a unipolar pacemaker, a device delivering dual-chamber or triple-chamber pacing, and/or a device delivering antitachyarrhythmia therapies

If incessant ventricular tachycardia (VT) or ventricular fibrillation (VF) exists

If the patient’s primary disorder is chronic atrial tachyarrhythmia with no concomitant VT or VF

If symptomatic bradycardia exists

If tachyarrhythmias with transient or reversible causes exist

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.

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 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 tool¹³

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.

Handle
Thumb tab
Stainless steel tunneling rod
External guide (removable)

This is an image of the entire Epsila EV™ sternal tunneling tool with numbered callouts.

SafeSheath™ II hemostatic peel-away introducer system¹⁴

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 tool¹⁵

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.

Handle
Channel for lead delivery
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

Resources

View the Aurora EV-ICD™ system brochure.

Aurora EV-ICD™ System Brochure (open in new window)

Download this brochure to learn more about the Aurora EV-ICD™ system.

PRODUCT PDF 2 MB

View the Epsila EV™ MRI SureScan™ defibrillator lead specifications sheet.

Epsila EV™ MRI SureScan™ Lead Specifications Sheet (open in new window)

Download this document for specification details on the Epsila EV™ MRI SureScan™ defibrillator lead.

PRODUCT PDF 891 KB

View the Epsila EV™ sternal tunneling tool specifications sheet.

Epsila EV™ Sternal Tunneling Tool Specifications Sheet (open in new window)

Download this specifications sheet to get technical information about the Epsila EV™ sternal tunneling tool used to implant the Aurora EV-ICD™ extravascular system.

PRODUCT PDF 904 KB

View the Epsila EV™ transverse tunneling tool specifications sheet.

Epsila EV™ Transverse Tunneling Tool Specifications Sheet (open in new window)

Download this specifications sheet to get technical information about the Epsila EV™ transverse tunneling tool used to implant the Aurora EV-ICD™ extravascular system.

PRODUCT PDF 678 KB

Similar products

TM* 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. Assumes no pacing, no high voltage therapy, and nominal settings.^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.

◊ Generalized estimating equations (GEE)-adjusted success rate (95% CI: 48.2%, 81.4%).

¶ Enlighten Study primary safety endpoint is chronic (> 30 days after implant) system-related major complications (excluding infections).

# Discrete episodes are defined as less than or equal to two events within 24 hours.

∆ Through an average 10.6-month follow-up.

∞ Kaplan-Meier estimate.

†† 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.

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.
Medtronic Aurora EV-ICD™ MRI SureScan™ DVEA3E4 implant manual. M991372A001 REV. E. Medtronic; 2013.
Emblem™* MRI S-ICD technical manual. Boston Scientific. Accessed October 30, 2025.

Friedman P, Murgatroyd F, Boersma LVA, et al. Performance and safety of the extravascular implantable cardioverter defibrillation through long-term follow-up: Final results from the Pivotal Study. Circulation. 2025;151(4):322–332. doi:10.1161/CIRCULATIONAHA.124.071795.
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.
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.
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.
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.
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.
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.
Crozier I. Real-world safety and efficacy of the extravascular ICD through six months: Outcomes from the Enlighten study post approval registry; late-breaking results. Presented at: APHRS 2025; November 13, 2025; Yokohama, Japan.
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.
Medtronic Epsila EV™ sternal tunneling tool Model EAZ101 technical manual. M999188A001 REV. D. Medtronic; 2023.
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.
Medtronic Epsila EV™ transverse tunneling tool Model EAZ201 technical manual. M999195A001 REV. D. Medtronic; 2023.

Aurora EV-ICD™ system