Slide 1: Real-World Safety and Efficacy of the Extravascular ICD through Six Months
Real-World Safety and Efficacy of the Extravascular ICD through Six Months: Outcomes from the Enlighten Study Post Approval Registry lan Crozier, MBChB Christchurch Hospital, Christchurch, NZ Co-Authors: Lucas VA Boersma, MD, PhD; Anish Amin, MD, FHRS; Francis Murgatroyd, FRCP, FHRS; Maciej Sterlins
Slide 2: Disclosures
Disclosures • The Enlighten Study is fully sponsored by Medtronic • Dr. Crozier: consultant for and research funding from Medtronic November 13, 2025 APHRS2025 JHRS2025
Slide 3: Background
Background • The extravascular implantable cardioverter-defibrillator Anterior and lateral views of implanted EV-ICD2 (EV-ICD) provides ATP and low energy defibrillation therapy while avoiding the vasculature • EV-ICD demonstrated a low complication rate and high therapy success rate in pre-market s
Slide 4: Study design and methods
Study design and methods Enlighten Study by the numbers • Enlighten is a global, multicenter, prospective, post- market registry study assessing safety and performance of the Aurora EV-ICD system through the life of the device • Characterize periprocedural outcomes 786 patients with • Update on prim
Slide 5: Baseline characteristics
Baseline characteristics Enlighten Pivotal1 Characteristic (N=786) (N=316) Mean age ± SD (years) 49.0 ± 15.2 53.8±13.1 Female 225 (28.6%) 80 (25.3%) Secondary Prevention† 268 (34.1%) 57 (18.0%) NYHA Functional Class III or IV 58/784 (7.4%) 23 (7.3%) Mean BMI ± SD (kg/m2) 27.4 ± 5.8 (N=779) 28.0 ± 5.
Slide 6: Implant procedure
Implant procedure Enlighten Study patient flow chart • 99.2% (780/786) tunneling and lead placement success • 96.2% (756/786) completed the procedure with a device • Mean procedure time (1st incision to final suture) was 81.0±38.2 min • Mean R-wave amplitude at implant was 2.9±1.6 mV (N=731 reported
Slide 7: Defibrillation testing
Defibrillation testing Defibrillation testing flow chart • 99.0% (701/708 reported) defibrillation testing success when performed at implant • Mean energy successful was 31.2±4.3J • 88.4% (569/644 reported) of those tested at ≤30J were successful *Defibrillation testing was performed per physician d
Slide 8: Intraprocedural complications
Intraprocedural complications • Six intraprocedural major complications† related to the system and/or procedure. All resolved without any lasting effects • Prolonged hospitalization to repeat defibrillation test (N=2), re-position device (N=2), replace lead due to lead movement (n=1) • Pneumothorax
Slide 9: Primary endpoint
Primary endpoint Freedom from system-related major complications • Primary endpoint† will be assessed at 5 years 99.0% 97.8% • 97.8% freedom from chronic system-related major complications at 6 months (Figure) • In line with Pivotal (98.0% at 6 months) • 8 system-related major complications in 8 pat
Slide 10: Infections
Infections • 11 of 786 (1.4%) patients with an implant attempt had a major system- and/or procedure- related infection (10 resolved, 1 pending) • System explanted (N=6) • Antibiotics only (N=3) • Wound or pocket revision (N=2) • No cases of mediastinitis, sepsis, or endocarditis related to the syste
Slide 11: Appropriate therapy
Appropriate therapy Rate of first appropriate therapy • 5.2% rate of first appropriate therapy at 6 months (Figure) • 195 total appropriately treated episodes in 44 Any therapy Shock patients through mean of 7.9 months follow-up: ATP 195 total appropriately treated episodes 5.2% Shock only ATP only
Slide 12: Characterization of ATP
Characterization of ATP • 66.9% adjusted† ATP success rate (60.3% raw success rate) through a mean of 7.9 months follow-up • 44 shocks avoided in 17 patients because of ATP through all follow-up • No patients had ATP programmed ‘Off’ after receiving ambulatory therapy Example of a successful ATP Ven
Slide 13: Inappropriate shock
Inappropriate shock Rate of first inappropriate shock • 5.5% rate of first inappropriate shock at 6 months (Figure) • 66 total inappropriate shocks in 43 patients through a mean of 7.9 months follow-up • 32.1% lower rate than what was observed in 5.5% Pivotal (8.1% rate at 6 months1) 4.2% 1.5% 1Frie
Slide 14: Inappropriate shock reduction
Inappropriate shock reduction Causes of inappropriate shock • 33.3% of inappropriate shocks due to PWOS in Enlighten (Figure) Other • 34.8% reduction in the proportion of inappropriate shock due to (5, 7.6%) PWOS compared to Pivotal1 (51.1% due to PWOS in Pivotal) AF, SVT Noncardiac • 100% (698/698)
Slide 15: Electrical performance
Electrical performance • Mean pacing capture threshold at implant was 5.8±2.0 V (N=401 reported) • R-wave measurements remained stable while lead impedance increased through 6 months (Figure) R-wave amplitude Lead impedance 475 380 2.6 2.6 Implant 6M Implant 6M (N=731) (N=554) (N=739) (N=603) *All m
Slide 16: Limitations
Limitations • Post-market registry with incomplete data and no control group • Short follow-up time to date; not all patients have reached 6 months of follow-up November 13, 2025 APHRS2025 JHRS2025
Slide 17: Conclusions
Conclusions Preliminary evidence from a large real-world cohort with more than a third secondary prevention patients, the Aurora EV-ICD has demonstrated: • A high implantation success rate & low rate of chronic complications through 6 months • 99.2% achieved tunneling and lead placement success • 96