Pre-Clinical Study - ZOLL AED Plus Guía Del Administrador

Conclusión: Los datos demuestran la eficacia equivalente de las descargas bifásicas rectilíneas de baja
energía comparadas con las descargas monofásicas estándar de alta energía en la desfibrilación
transtorácica para todos los pacientes con un nivel de confianza del 95%. Asimismo, los datos
demuestran una mejor eficacia de las descargas bifásicas rectilíneas de baja energía comparadas con las
descargas monofásicas estándar de alta energía en pacientes de alta impedancia transtorácica con un
nivel de confianza del 90%. No se documentaron consecuencias peligrosas o sucesos adversos
relacionados con el uso de la forma de onda bifásica rectilínea.
* Kerber, R., et. al., AHA Scientific Statement, Circulation, 1997; 95: 1677-1682:
"... the task force suggests that to demonstrate superiority of an alternative waveform over standard
waveforms, the upper boundary of the 90% confidence interval of the difference between standard and
alternative waveforms must be < 0% (i.e., alternative is greater than standard)." ("...el equipo sugiere
que para demostrar la superioridad de una forma de onda alternativa sobre la forma de onda estándar,
el límite superior del intervalo de confianza del 90% de la diferencia entre la forma de onda estándar y
las forma de onda alternativa debe ser < 0% (es decir, la alternativa es mayor que la estándar).")

Pre-Clinical Study

To support pediatric usage for the ZOLL Rectilinear Bi-Phasic Waveform, ZOLL submitted
pre-clinical data to the FDA as part of a 510(k) submission for its AED Plus device (cleared by the FDA
under K033474). The protocol for this pre-clinical study, along with a summary of the results, have
been submitted to FDA under AED Plus PMA application (P160015). A summary of this study is
presented below.
To demonstrate the safety and efficacy of our Rectilinear Bi-Phasic Waveform when used to treat
pediatric VF patients, ZOLL conducted a study using a porcine model of pediatric patients less than 8
years of age. This study included 18 piglets in three (3) size groups (two (2) animals weighing 4 kg,
eight (8) animals weighing 8 kg, and eight (8) animals weighing 16 kg) and compared the defibrillation
dose/response curves observed using proposed biphasic waveform with those observed using a
standard monophasic damped sine wave (DSW) defibrillator to treat short duration (~ 30 seconds)
ventricular fibrillation. The study demonstrated that the biphasic waveform defibrillates pediatric pigs
with equal efficacy but lower energy (on a Joules/kg basis) than traditional monophasic damped sine
wave defibrillators. To confirm the safety of the proposed biphasic waveform in pediatric patients, we
studied and compared measures of cardiac function before and after both DSW and Rectilinear
Bi-Phasic Waveform defibrillation shocks over a range of relevant energies. The study demonstrated
that the biphasic defibrillation produced equivalent or milder disturbances of cardiac function when
compared to traditional DSW defibrillation at the same energies.
Another animal study compared the ZOLL rectilinear biphasic (RLB) waveform to a biphasic truncated
exponential (BTE) waveform. The study, using an immature porcine model (n=21), was a prospective,
randomized, controlled design to determine the dose response curves for the RLB and BTE
defibrillation waveforms. A weight range from 4 to 24 Kg for an animal represented a pediatric patient.
The weight ranging from 4 to 8 Kg represented a patient less than 1 year old (infant subgroup), and the
weight range from 16 to 24 Kg represented a pediatric patient between the ages of 2 and 8 years (young
children subgroup).
The ZOLL RLB waveform demonstrated a superior capability to defibrillate a porcine pediatric model
with < 90% of the D50 energy required for a BTE waveform (D50 energy: RLB 25.6 ± 15.7 J, BTE
28.6 ±17.0 J, P ? 0.0232; D90 energy: RLB 32.6 ± 19.1 J, BTE 37.8 ± 23.2 J, P ? 0.0228).
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