BIOTRONIK Lumax DR ICD Series, Technical Manual, Page: 47 / 176

Lumax Technical Manual 39
The pulse generator related complication rate is higher in the
control group as compared to the study group. The complication
rates for procedure related, atrial lead related, ICD lead related,
LV lead related and other medical related are higher in the study
group as compared to the control group.
1.6.2.9 Post hoc Safety Analysis Conclusion
There are no clinically substantial differences in the total
complication rate or in the rates for the different complication rate
categories between the study and the control group.
Table 10 compares this post-hoc Safety Endpoint analysis to
previous CRT-D clinical studies:
Table 10 Safety Endpoint Comparisons
CRT-D Study
Estimated
freedom from
Complications
@ 6mos.
Lower 95%
CI
95%
lower
bound
criteria
BIOTRONIK OPTION
(Original Analysis)
70.68% 63.5% 75%
BIOTRONIK OPTION
(Post-hoc Analysis)
78.95% 72.29% 75%
Medtronic Insync ICD 81.1% 77.6% 67%
Guidant Contak CD N/A N/A 70%
St. Jude Medical Epic
HF
93.4% 90.6% 70%
This analysis confirms that the safety profile of the Tupos LV/ATx
is within a similar range determined during trials of other legally
marketed CRT-D devices.