IFU-00367 Rev A
The Avive defibrillation waveform safety and effectiveness is supported through published clinical data for
defibrillation, including studies by Schneider et al., Poole et al., and White et al.
Schneider et al.
Schneider T, et al. Multicenter, Randomized, Controlled Trial of 150-J Biphasic Shocks Compared with 200-J to 360-J Monophasic shocks in the
Resuscitation of Out-of-Hospital Cardiac Arrest Victims. Circulation. 2000;102:1780-1787.
A prospective, multicenter, out-of-hospital clinical trial was conducted to support adult defibrillation by
comparing AEDs that delivered 150 J biphasic shocks with AEDs that delivered high-energy 200 - 360 J
monophasic shocks. The Schneider et al. study delivered a sequence of up to three defibrillation shocks for the
biphasic devices (150 J – 150 J – 150 J). Monophasic units delivered 200 J – 200 J – 360 J shocks. In the
Schneider study, a greater percentage of patients achieved return of spontaneous circulation (ROSC) after
biphasic shock (76% vs. 54%). There was no statistical difference between the two waveforms for rates of
survival to hospital admission and discharge.
Poole et al.
Poole J, et al. Low-Energy Impedance-Compensating Biphasic Waveforms Terminate Ventricular Fibrillation at High Rates in Victims of Out-of-
Hospital Cardiac Arrest. Journal of Cardiovascular Electrophysiology. 1997;8:1373-1385.
The performance of the 150 J impedance-compensating biphasic waveform was observed in the out-of-
hospital setting on 100 consecutive victims of sudden cardiac arrest across 12 EMS systems. A total of 202 VF
episodes were handled in the 44 patients presenting with VF. A single 150 J biphasic shock defibrillated the
initial VF episode in 39 of 44 (89%) patients. 95% terminated VF after two shocks, and 99% terminated with 3
shocks or fewer. At patient transfer to ALS or ED care, an organized rhythm was present in 34 of 44 (77%) of
patients presenting with VF. Asystole was present in 7 (16%) and VF in 3 (7%). The average number of shocks
delivered per initial VF episode was 1.2 ± 0.5. A very wide range of patient resistances (36 Ω to 171 Ω) was
exhibited, confirming that automated impedance compensation maintains high efficacy without the need to
either step-up energy levels or use high-energy shocks. The 150 J impedance-compensating biphasic waveform
terminates long-duration VF at high rates in out-of-hospital cardiac arrest.
White et al.
White R, et al. Transthoracic impedance does not affect defibrillation, resuscitation or survival in patients with out-of-hospital cardiac arrest treated
with a non-escalating biphasic waveform defibrillator. Resuscitation. 2005;64(1):63–69.
Cardiac arrest data from two EMS systems were analyzed retrospectively, totaling 102 out-of-hospital-cardiac-
arrest patients treated by fixed, 150 J, biphasic AEDs. Initial shocks defibrillated 90% of patients. Cumulative
success with two shocks was 98% and with three shocks was 99%. Patient impedance ranged from 27 Ω to 152
Ω. First-shock success, cumulative success through two shocks, and cumulative success through the first-shock
series were unrelated to transthoracic impedance, as were BLS ROSC, pre-hospital ROSC, hospital admission,
and discharge. Consistent with previous findings, call-to-shock time was highly predictive of survival. High
impedance patients were defibrillated by the biphasic waveform used in this study at high rates with a fixed
energy of 150 J and without energy escalation. Rapid defibrillation rather than differences in patient
impedance accounts for resuscitation success.
Pediatric Animal Study
A pediatric porcine animal study provides evidence to support the reasonable assurance of safety and
effectiveness of the Aviveä pediatric defibrillation waveform in the pediatric sub-population of children 1 to 8
years old. The Avive pediatric defibrillation waveform successfully defibrillated all animals in the pediatric
animal model, with no clinically significant abnormal clinical pathology, daily observations, macroscopic, or
microscopic findings.
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