300282-002 Rev. E0
©2002 Cardiac Science, Inc.
Page 81
Section 7: Technical Data
Clinical Study Summary
Comparison of Survivalink’s Biphasic and
Monophasic Truncated Exponential Waveforms
An IDE Clinical Study was performed. The first shock efficacies of the
control Monophasic truncated exponential waveforms were compared to
the first shock efficacy of the Biphasic truncated exponential waveforms.
The study was divided into two sections. The first section was a low
energy section comparing a 200J (low energy) Monophasic versus a
200J
3
(low current) Biphasic. The second section was a high energy
section comparing a 360J (high energy) Monophasic versus a 300J (high
current) Biphasic. Each section was a prospective, randomized, blinded,
study designed with an independent group of patients for each section.
All patients undergoing procedures for electrophysiological testing or
implantation of ICDs were invited to enroll in the study.
A total of 115 first shocks were delivered for both the Monophasic and
Biphasic waveforms. Of the 115 first shock attempts, 60 were in the low
energy arm and 55 in the high energy arm. There were no adverse events
associated with any of the treatments.
** highly statistically significant
3. Survivalink AED Models 9200/9210: The low current and high current shocks are variable energy. The actual
energy is determined by the patient’s impedance.
TABLE 1.
Defibrillation Rate of Survivalink’s Monophasic and
Biphasic Waveforms
Monophasic
Waveform
Biphasic
Waveform
Statistical
Analysis
Overall First Shock Success; n = 115
(95% Confidence Interval)
97.4%
(94.5% - 100%)
100%
(100)%)
p = 0.0001**
Low Energy First Shock Success; n =604
(95% Confidence Interval)
96.7%
(92.2% - 100%)
100%
(100)%)
p = 0.002**
High Energy First Shock Success; n = 55
(95% Confidence Interval)
98.2%
(94.7% - 100%)
100%
(100)%)
p = 0.0001**
