Extravascular advantages
Aurora EV-ICDTM offers the advantages of an extravascular system while also providing ATP and Pause Prevention pacing in a device the same size as transvenous ICDs.
Transvenous benefits
Antitachycardia pacing (ATP)
The only extravascular ICD to offer ATP in studies of transvenous ICDs, even with extended detection intervals. ATP was associated with a 50% reduction in potentially unnecessary shock1-3 ,70% ATP-terminated episode success rate through an average10.6-month follow-up, avoiding 33 shocks in 7 patients.4
Longevity
11.7 years projected longevity5 which is similar to other Medtronic single chamber ICDs. Greater longevity can reduce 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 supports.
Size and PhysioCurveTM design
Minimizes tissue pressure and promote patient comfort6.
Clinical data
The Enlighten Study is an ongoing global, prospective, observational, multisite registry study.9 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 space10 (756 patients with a successful implant with average follow-up of 7.9 months).
High ATP success10
- 67% ATP success rate,∆ in line with transvenous ICDs1-2-12-13 and consistent with EV ICD Pivotal Study performance4
- 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
Safe, low risk of complications10
- 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
Effective defibrillation10
- 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
Inappropriate shock10
- 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 months14).
- The proportion of inappropriate shocks due to P-wave oversensing decreased from 51% of episodes in the EV ICD Pivotal Study14 to 33% in Enlighten.10
- There are three strategies for mitigating inappropriate shock: lead positioning at implant, use of the Smart Sense algorithm, and device programming.
Medtronic EV ICD Pivotal Study
Primary results†4
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 episodes.§
Successful ATP
70% of episodes successfully terminated, avoiding 33 shocks in seven patients7 (through 10.6 months average follow-up).
Long-term results†8
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 due to ATP.||
- ATP utilization increased significantly through the duration of follow-up (p < 0.0001).¶
- No patient with successful ATP had therapy programmed off subsequently.
Shock treated = 44 episodes
ATP treated and shock avoided = 38 episodes
Safe procedure, safe system†8
- No major intraprocedural complications.
- No unique major 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.
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Footnotes
*
Kaplan-Meier estimate
† Through an average 10.6-month follow-up
‡ The Aurora EV-ICD lead 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(4)
§ Discrete episodes are defined as less than or equal to two events within 24 hours.
|| Follow-up duration is an average of 30.6 months for the n = 299 patients with a successful implant.
¶ Based on a paired statistical test comparing prehospital discharge to last available follow-up.
# Implant success is a patient proceeding from implant to follow-up with an implanted device.
∆ 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).
References
1
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.
2
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.
3
Brown ML, Gerritse B, Kurita T, et al. Anti-tachycardia Pacing Benefits Non-ischemic AND Ischemic Patients equally in the PainFreeSST trial. Heart Rhythm. 2018;15(5);S590-S640.
4
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.
5
Medtronic Aurora EV-ICDTM MRI SureScanTM DVEA3E4 Device Manual.
6
Thompson A. Lead extraction study. Medtronic data on file. November 2021.
7
Crozier I, et al. Primary Outcome Results from the Global Extravascular Implantable Cardioverter Defibrillator (EV ICD) Pivotal Study. Late Breaking Clinical Trial Presentation at ESC 2022. August 28, 2022. Barcelona Spain.
8
Murgatroyd F, 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. September 2, 2024. London, U.K.
9
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.
10
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.
11
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.
12
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.
13
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.
14
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.
