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
Overview
Aurora EV-ICD, the extravascular system with transvenous ICD features.
System details
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 antitachycardia pacing (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).†,6,3
The Aurora EV-ICD™ system:
- Avoids certain complications associated with transvenous leads‡
- Preserves the vasculature and reduces the potential for injury‡
Transvenous ICD features
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.§, 11 This is in the range of the ATP efficacy reported in transvenous ICD publications, 52% to 87%.2,4,5,12
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.
Pause Prevention — A pacing feature that monitors the heart for significant pauses and responds by providing temporary bradycardia pacing support.2–9, 12
Size and PhysioCurve™ design — Small size (33 mL) and PhysioCurve™ design — same size and shape as Medtronic transvenous single-chamber ICDs6
Monitor zone - which allows for documentation of slow ventricular tachycardias (VTs), including nonsustained VTs2
Programmable ventricular fibrillation (VF) detection intervals and multiple therapy zones.
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
- Coil 1 electrode (defibrillation)
- Ring 1 electrode (sensing)
- Coil 2 electrode (defibrillation)
- Ring 2 electrode (sensing)
- Preformed bend
- Anchoring sleeve
- Blue insertion indicator
- Connector pin
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.∆,13
- 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
Long-term results§,∆,11
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 utilization 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.
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
- Handle
- Thumb tab
- Used to raise and lower the external guide
- 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
- Preformed bend
- Facilitates contact with the posterior side of the sternum
- Stainless steel tunneling rod
- Delivers an introducer to the anterior mediastinum
Epsila EV™ transverse tunneling tool
Model EAZ201
Flexible tunneling rod for tracking across the chest
- Handle
- 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
Videos
Model specifications
| Item number | Product | Description |
|---|---|---|
|
DVEA3E4 |
Aurora EV-ICD™ MRI SureScan™ |
Extravascular implantable cardiovascular defibrillator |
|
EV2401 |
Epsila EV™ MRI SureScan™ |
Extravascular quadripolar lead with shaped passive fixation– 52 cm |
|
EV2401 |
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 |
Related pages
Educational resources on Medtronic Academy
Access interactive courses, videos, and educational resources to extend your learning on Aurora.
®* Third-party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company.
* 67% of episodes successfully treated with ATP at 18 months (35/52 episodes).
§ Follow-up duration is an average of 30.6 months for the n=299 patients with a successful implant.
∆ Follow-up duration is an average of 29.0 months for the n=316 patients with an implant attempt.
‡ 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 Study1
† Projected battery longevities are as reported in the approved device labeling.3,6
◊ Through an average 10.6-month follow-up.
∞ Based on a paired statistical test comparing pre-hospital discharge to last available follow-up.
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
Emblem MRI S-ICD technical manual. Boston Scientific. Accessed August 28, 2023.
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.
11
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. LBCT oral presentation at ESC. 2024. London, U.K.
12
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.
13
Crozier I. Primary outcome results from the global extravascular implantable cardioverter defibrillator (EV ICD) pivotal study. Late breaking clinical trial presentation at ESC. August 28, 2022. Barcelona Spain.
