| 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 |
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>
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.§,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
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
Medtronic EV ICD Pivotal Study
Primary results◊,1
Effectively terminated life-threatening rhythms with ATP and shocks while safely outside the vascular space.
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 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.
Product details
Epsila EV™ defibrillation lead design
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
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 and Epsila EV™ transverse tunneling tools
Our Epsila EV™ sternal and transverse tunneling tools are designed to deliver a lead during the implantation procedure of the Aurora EV-ICD™ system.
Epsila EV™ sternal tunneling tool12
The Epsla 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)
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
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.
- Handle
- Channel for lead delivery
- Tunneling rod
Ordering information
Related links
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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.
◊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.
- 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.
- Medtronic Aurora EV-ICD™ MRI SureScan™ DVEA3E4 device manual.
- Emblem MRI S-ICD technical manual. Boston Scientific. Accessed August 28, 2023.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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. Poster presentation at AHA 2021. doi:10.1161/circ.144.suppl_1.13966.
- Medtronic Epsila EV™ EAZ101 sternal tunneling tool technical manual.
- 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™ transverese tunneling tool Model EAZ201 technical manual.