2-6
70-02053-31 A
Powerheart® AED G3 Elite 9790A and 9790E
Introduction
The data collected demonstrated sensitivity of 100.0%, positive
predictivity as 93.9%, and specificity as 99.4%. The initial sample
size calculations assumed an expected sensitivity of 90%. The
actual sensitivity of 100% calculated in this trial allowed a smaller
number of patients to be entered in the study while still providing
the necessary high confidence limits. The Powerheart® AED’s
arrhythmia detection and therapeutic capabilities, as well as
its safety and efficacy have been demonstrated with a high
confidence level.
STAR® Biphasic Waveform IDE G970230
Study objective:
To evaluate the first shock efficacy of monophasic
and STAR® Biphasic Waveforms for external defibrillation.
Methods:
A prospective, randomized, blinded, multi-center study
of 118 patients undergoing electrophysiologic testing or receiving
an implantable defibrillator was conducted. Ventricular fibrillation
was induced, and defibrillation was attempted in each patient
with a biphasic and a monophasic waveform. Patients were
randomly placed into two (2) groups: Group 1 received shocks of
escalating energy, and Group 2 received only high energy shocks.
Results:
The STAR® Biphasic Waveform achieved a first-shock
success rate of 100% in Group 1 (95% confidence interval [CI]
95.1% to 100%) and Group 2 (95% CI 94.6% to 100%), with average
delivered energies of 201±17 J and 295±28 J, respectively. The
monophasic waveform demonstrated a 96.7% (95% CI 89.1% to
100%) first-shock success rate and average delivered energy of
215±12 J for Group 1, and a 98.2% (95% CI 91.7% to 100%) first-
shock success rate and average delivered energy of 352±13 J for
Group 2.
Conclusion:
The STAR® Biphasic Waveform was validated in a
multicenter clinical trial led by researchers at the Cleveland Clinic
and Cedars-Sinai Medical Center. The analysis showed that the
overall first-shock defibrillation success rate with the STAR®
Biphasic Waveform is statistically higher than the monophasic
damped sine or the 150J non-escalating biphasic waveform.
