BIOTRONIK Lumax DR ICD Series, Technical Manual, Page: 37 / 176

Lumax Technical Manual 29
Primary Endpoint
The safety of the Kronos LV-T was evaluated based on
complications (adverse events that require additional invasive
intervention to resolve) related to the implanted CRT system
which includes the Kronos LV-T, the right atrial lead, the right
ventricular ICD lead, and the left ventricular lead. 5 complications
were seen in 3 patients with cumulative implant duration of 202
months (16.8 patient-years). 6.7% of the patients had a reported
complication. The rate of complications per patient-year is 0.30.
The freedom from Kronos LV-T system-related complications is
93.3% with a two sided lower 95% confidence bound of 83.8%.
The null hypothesis is rejected, and it is concluded that the
complication-free rate is equivalent to 85% within 10%.
1.6.2 Tupos LV/ATx Study
N
OTE
:
The clinical study information included in this section was
performed with the Tupos LV/ATx CRT-D, which is an earlier
version of the Lumax CRT-D/ICD families. The clinical study
data presented here is applicable because the Lumax family
are downsized versions of the Tupos LV/ATx CRT-D and
Tachos ICD families. The Lumax family is slightly different as
compared to the Tupos LV/ATx (and Tachos family) in the
following areas:
•
Reduced size from 50/48 cc to 40/35 cc
•
Addition of Home Monitoring functionality
•
Addition of triggered pacing for biventricular pacing
modes
•
True three chamber pacing and sensing capabilities
(CRT-Ds)