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These publications include discussions of unapproved uses that have not been approved by FDA. The safety and effectiveness of the medical product for the unapproved use has not been established. Users are encouraged to review the full labeling for the product, as well as all disclosures about the individual publications.

Summary

  • Sudden cardiac death due to ventricular arrhythmia remains a significant risk in pediatric patients. Long-term risks associated with the use of transvenous cardiac implantable electronic systems in pediatric patients include infection, vessel occlusion or obstruction, lead dislodgement, lead perforation, mechanical lead failure, as well as uncertain impact of patient growth on lead position and function.
  • The Aurora EV-ICD™ system, an extravascular ICD with a single lead implanted substernally, enables pause-prevention and post-shock pacing, antitachycardia pacing and defibrillation with energy similar to transvenous implantable cardioverter defibrillators (ICD). The Aurora EV-ICD™ Pivotal Trial included patients eighteen years of age and older.1 As the use of Aurora EV-ICD™ system in the pediatric population has not been prospectively evaluated, it is considered off-label use.
  • Four single-center case series of Aurora EV-ICD™ system use in adolescent pediatric patients are presented below which describe implant procedure, procedural and device programming modifications, early clinical outcomes and device performance in this unique population.
  • Key limitations of these case series include:
    • Small sample sizes from a single center and short follow-up duration.
    • The majority of the patients in these reports are adolescent pediatric patients with body size similar to adult size as opposed to young pediatric patient size.
    • These case series are unable to assess the impact of body growth on lead position and integrity, the ability to extract the substernal lead after long dwell times, and the impact of higher intrinsic heart rates on inappropriate shocks in this population.
    • Therefore, broad application of these results to the general pediatric population should be considered with caution.

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Medtronic summary

Patient population and methods
  • 7 patients
    • Primary prevention (5)
    • Secondary prevention (2)
  • Mean age: 13.2 years (range 11–15)
    Mean BMI: 17.9 ± 1.6 kg/m2
  • Pre-implant testing: ECG, cardiac MR and/or and CT for implant guidance
  • Sternum to pericardium distance < 5 mm
  • Subcutaneous loop retained in lead to accommodate patient growth
  • General anesthesia (2)
    Deep sedation/local analgesia (5)
Results
  • Electrical measurements:
    • Implant R-waves 5.3 ± 2 mV
    • Follow-up R-wave: 4.6 ± 2 mV

 R1-R2 sensing configuration

  • DFT:
    • 100% success
    • Mean energy for success: 18.5 ± 5 J
  • Follow-up observations:
    • Stable device function through 9 ± 6 months
    • 2 VT episodes successfully treated by ATP (1)
    • Heart transplant after 10 months;
      EV-ICD system removed without adhesions (1)
    • Non-competitive sports resumed (4)

Figure 1: Implant in a 12-year-old boy with hypertrophic cardiomyopathy. See Ring 1 and 2 in front of the RV, the abdominal loop, and the intermuscular placement.

Source: Biffi M, Quaranta A, Carecci A, et al. The extravascular implantable defibrillator: a novel opportunity for the paediatric population. Europace. 2025;27(7):euaf128. doi:10.1093/europace/euaf128.

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Medtronic summary

Patient population and methods
  • 5 patients:
    • Primary prevention (3)
    • Secondary prevention (2)
  • Average age: 16.8 years (14–19)
    Average weight†: 98.3 kg (81.7–133.5)

† Adolescent patients, adult-sized anatomy.

  • Pre-implant testing: chest CT or MRI
  • Follow-up:
    • 4–6 weeks post-implant
    • Every 3–6 months thereafter
    • Range: 5–9 months
  • General anesthesia (all patients)
Results
  • Electrical measurements‡:
    • Implant:
      • R-wave: 2.1–4.7 mV
      • Impedance: 247–399 ohms
    • Follow-up:
      • R-wave: 2.2–4.4 mV
      • Impedance: 323–539 ohms

‡ Trivial P- or T-wave oversensing noted at follow-up; no inappropriate shocks.

  • DFT:
    • Success, first attempt at 25 J (4)
    • Success, 30 J after failed 25 J (1)
  • Procedure modifications
    • Curved Kelly forceps for diaphragmatic attachment dissection
    • Modified anchoring suture placement

Figure 2: Transition from an S-ICD (right-sided images) in a 14-year-old male with TNNI3K mutation. The original S-ICD generator pocket was reused without the need for plication.

Source: Dragisic N, Backes E, Malloy-Walton L, et al. Short- and mid-term outcomes of the extravascular implantable cardioverter-defibrillator in the pediatric and adolescent patients: a single-center experience. J Innov Card Rhythm Manage. 2025;16(11):6488–6495. doi:10.19102/icrm.2025.16113.

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Medtronic summary

Patient population and methods
  • 3 patients
    • Primary prevention (2)
    • Secondary prevention (1)
  • Ages: 6, 12, 16
  • Weight range: 20–45 kg
  • Height range: 121–161 cm
  • Pre-implant testing: chest CT or MRI
  • 6-week follow-up reported
  • General anesthesia provided (all patients)
Results
  • Electrical measurements:
    • Implant R-wave: 3.5–4.6 mV
    • Follow-up R-wave: 3.5–4.4 mV
  • DFT:
    • Success, first attempt at 30 J (2)
    • 1 patient non-inducible
  • Observations:
    • 1 patient — 2 tunneling attempts
    • 1 patient — appropriate and successful ICD therapy
    • All patients satisfied cosmetically
  • Programming:
    • ATP programmed on in all cases

Figure 1: Postanterior chest x-rays for females aged 16 (1a, b), 12 (2a, b), 6 (3a, b)

Source: Spentzou G, Yaya SA, Barman P. Initial experience of the Medtronic Aurora extravascular implantable cardioverter in children in a UK centre. Pediatr Cardiol. Published October 22, 2025. doi:10.1007/s00246-025-04031-z.

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Medtronic summary

Patient population and methods
  • 12 patients
    • Primary prevention (11)
    • Secondary prevention (1)
  • Median age: 14.5 years (range 9–16)
    Median weight: 51 kg (range 27–82)
  • Tunneling during expiration
  • Pre-implant testing: chest CT or MRI
  • Median follow-up: 5 months
  • General anesthesia (all patients)
Results
  • Electrical measurements:
    • Median R-wave: 3.7 mV (range 1.1–11.2)
  • DFT:
    • Success, first attempt at 30 J (9)
    • 3 patients non-inducible
  • Complications:
    • Pleural placement (1) in smallest patient
    • Air in substernal region resulting in noise (4); resolved after 24 hours
    • No late complications; 1 lead noise oversensing event while showering that did not result in an inappropriate shock
  • Programming:
    • VF zone: 200–207 bpm
    • VT monitor zone: 180 bpm
    • ATP during charge ON

Figure 1: Final chest x-ray of the smallest patient in the cohort, a 9-year-old female with Brugada syndrome and a weight of 27 kg.

Source: Walsh M, Ryan C, Prendiville T, et al. Initial experience with the extravascular implantable cardioverter-defibrillator in pediatric patients. Heart Rhythm O2. 2025;7(1):103–108. doi: 10.1016/j.hroo.2025.10.020.

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Disclosures

Aurora EV-ICD™ system has not been studied for pediatric use. The safety and effectiveness of the Aurora EV-ICD™ system in a pediatric patient population have not been established.

FDA approved use for Aurora EV-ICD™ MRI SureScan model DVEA3E4: The 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
  • 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).

The device has not been tested specifically for pediatric use.

FDA approved use for Epsila EV MRI SureScan model EV2401: 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.

FDA approved use for Epsila EV™ EAZ101 Sternal tunneling tool: The Epsila EV™ Model EAZ101 sternal tunneling tool is indicated for use in the implant of a compatible anterior mediastinum defibrillation lead. The tool has not been tested specifically for pediatric use.

FDA approved use for Epsila EV™ EAZ201 Transverse tunneling tool: the Epsila EV™ model EAZ201 transverse tunneling tool is indicated for use in the implant of a compatible anterior mediastinum defibrillation lead. This tool has not been tested specifically for pediatric use.

Warnings and precautions

The FDA-required labeling contains the following warnings and precautions about this off-label use of Aurora EV-ICD™ MRI SureScan model DVEA3E4.

Aurora EV-ICD™ MRI SureScan DVEA3E4:

Pediatric use: The device has not been tested specifically for pediatric use.

Serious, Life-threatening, Fatal Risks: The following are known potential adverse events associated with the use of Aurora EV-ICD™ system. In addition, this off-label use is associated with the following serious, life-threatening, fatal risks described in the labeling:

Note: Implant and usage of this product may result in adverse events, which may lead to injury, death, or other serious adverse reactions.

  • Acute tissue trauma
  • Allergic reaction
  • Bradyarrhythmia
  • Cardiac arrest
  • Death
  • Device migration
  • Dizziness
  • Dyspnea
  • Erosion
  • Extracardiac stimulation
  • Fever
  • Hematoma
  • Hiccups
  • Hospitalization
  • Inappropriate shock
  • Infection
  • Lethargy
  • Mental anguish
  • Palpitations
  • Return of cardiac symptoms
  • Seroma
  • Syncope
  • Tachyarrhythmia
  • Toxic reaction
  • Wound dehiscence

Serious, Life-threatening, Fatal Risks: The following are known potential adverse events associated with the use of Epsila EV™ MRI SureScan EV2401. In addition, this off-label use is associated with the following serious, life-threatening, fatal risks described in the labeling.

Note: Implant and usage of this product may result in adverse events, which may lead to injury, death, or other serious adverse reactions.

  • Acute tissue trauma
  • Allergic reaction
  • Bradyarrhythmia
  • Cardiac arrest
  • Cardiac inflammation
  • Cardiac perforation
  • Cardiac tamponade
  • Death
  • 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)
  • Palpitations
  • Pericardial effusion
  • Pneumothorax
  • Return of cardiac symptoms
  • Seroma
  • Syncope
  • Tachyarrhythmia
  • Toxic reaction
  • Wound dehiscence

Epsila EV™ EAZ101 Sternal tunneling tool

Pediatric use: The tool has not been tested specifically for pediatric use

Serious, Life-threatening, Fatal Risks: The following are foreseeable potential adverse events associated with the use of Epsila EV™ EAZ101 sternal tunneling tool:

  • Acute tissue trauma
  • Allergic reaction
  • Cardiac perforation
  • Cardiac tamponade
  • Death
  • Discomfort
  • Hematoma
  • Hemorrhage
  • Hemothorax
  • Infection
  • Organ damage (liver, mammary arteries, diaphragmatic arteries)
  • Pain
  • Pericardial effusion
  • Pericarditis
  • Pneumothorax
  • Seroma

Note: if a serious incident related to the device occurs, immediately report the incident to Medtronic and the applicable competent authority or regulatory body.

Epsila EV™ EAZ201 Transverse tunneling tool: Pediatric use – The tool has not been tested specifically for pediatric use

Potential adverse events

The following are foreseeable potential adverse events associated with the use of Epsila EV™ EAZ201 transverse tunneling tool:

  • Acute tissue trauma
  • Allergic reaction
  • Death
  • Discomfort
  • Hematoma
  • Hemorrhage
  • Infection
  • Pain
  • Seroma

Note: if a serious incident related to the device occurs, immediately report the incident to Medtronic and the applicable competent authority or regulatory body.

FDA approved labeling

Contraindications

The labeling for Aurora EV-ICD™ defibrillation system includes the following contraindications:

Aurora EV-ICD™ MRI SureScan™ DVEA3E4: The Aurora EV-ICD MRI SureScan Model DVEA3E4 device is contraindicated for use in the following situations:

  • If implanted with a unipolar pacemaker
  • If implanted with a device delivering dual-chamber or triple-chamber pacing
  • If implanted with a device delivering antitachyarrhythmia therapies
  • If incessant VT or 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

Epsila EV™ MRI SureScan™ EV2401: The Epsila EV MRI SureScan Model EV2401 lead is contraindicated for any application that is not specified in the Indications.

Epsila EV™ EAZ201 Transverse tunneling tool: The Epsila EV Model EAZ201 transverse tunneling tool is contraindicated for any application that is not specified in the indications.

Epsila EV™ EAZ101 Sternal tunneling tool: The Epsila EV Model EAZ101 sternal tunneling tool is contraindicated for use in patients with a prior sternotomy.

Financial disclosures

Biffi: There are no conflicts of interest declared.
Dragisic: There are no conflicts of interest declared.
Walsh: There are no conflicts of interest declared.
Spentzou: There are no conflicts of interest declared.