User Manual

Lumax Technical Manual 63
 The safety event rate for a 12 month duration for Group 1
(HM) was non-inferior to the safety event rate for Group 2
(Control) within 5% (p = 0.005). The upper, one-sided 95%
confidence bound for the difference was 2.7%.
 The mean time from onset to evaluation of AF, VT and VF
events indicates that those events for Group 1 patients are
evaluated in significantly less time when compared to Group
2 patients (AF p = 0.005, VT p < 0.001, VF p < 0.001).
1.6.5 Deikos A+
NOTE:
The clinical study information included in this section was
performed with the Deikos A+ ICD and the Kainox VDD ICD
lead. Due to the similarities in detection and therapy a clinical
study of the Lumax 540 VR-T DX with the Kainox A+ was not
performed.
The Deikos A+ was formed on the Tachos DR platform,
whereas the Lumax 540 VR-T DX was formed on the
Lumax DR-T platform. Both ICDs are designed to be used
with a VDD lead. In this study, the Kainox VDD lead (single
shock RV shock coil and dual atrial floating dipoles) was
implanted. In order to enhance the intrinsic signal from the
floating dipoles, both ICDs contain an atrial sensing amplifier.
The signal is amplified 4 times in the Deikos A+ and 5 times
in the Lumax 540 VR-T DX.
Both the Kainox VDD and the Kainox A+ ICD leads have
identical floating electrodes in the atrium and identical pacing
electrode tip, ring and shock electrodes designed for
placement in the right ventricle. The minor differences are in
the ventricular shock coil (Kainox A+ coil has a slightly larger
surface area, and the surface is not coated with fractal
iridium).