BIOTRONIK Lumax DR ICD Series, Technical Manual, Page: 56 / 176

48 Lumax Technical Manual
The gender distribution in this clinical investigation is consistent
within the study groups and includes a representative proportion
of female participants. There were no significant differences in
any of the primary or secondary endpoints between the male and
female population.
1.6.2.12 Conclusions
The IDE Clinical study (OPTION LV/ATx) demonstrated that the
safety and effectiveness of the Tupos LV/ATx CRT-D device is
equivalent to that of similar legally marketed CRT-D devices.
Although the study missed its primary safety endpoint, additional
post hoc analyses were conducted to reassure that the safety
profile of the device is comparable to other legally marketed
CRT-D devices.
1.7 Patient Selection and Treatment
1.7.1 Individualization of Treatment
•
Determine whether the expected device benefits
outweigh the possibility of early device replacement for
patients whose ventricular tachyarrhythmias require
frequent shocks.
•
Determine if the device and programmable options are
appropriate for patients with drug-resistant
supraventricular tachyarrhythmias (SVTs), because drug-
resistant SVTs can initiate unwanted device therapy.
•
Direct any questions regarding individualization of patient
therapy to your BIOTRONIK representative or
BIOTRONIK technical services at 1-800-547-0394.
The prospective patient’s size and activity level should be
evaluated to determine whether a pectoral or abdominal implant
is suitable. It is strongly recommended that candidates for an
ICD/CRT-D have a complete cardiac evaluation including EP
testing prior to device implant to gather electrophysiologic
information, including the rates and classifications of all the
patient’s cardiac rhythms. When gathering this information,
delineate all clinically significant ventricular and atrial arrhythmias,
whether they occur spontaneously or during EP testing.