BIOTRONIK Lumax DR ICD Series, Technical Manual, Page: 49 / 176

Lumax Technical Manual 41
2. The purpose of Secondary Endpoint 2 is to evaluate VT
(ventricular tachycardia) and VF (ventricular fibrillation)
detection times of the Tupos LV/ATx. This is a measure of
the ability of the ventricular detection algorithm to detect VT
and VF in an appropriate timeframe. This endpoint was
evaluated based on the review of electrograms following
induced VT/VF episodes. A comparison of data from the
TACT study that utilized the legally marketed Tachos DR –
Atrial Tx ICD (P000009/S4, dated 09-09-2002) to data
collected during the OPTION study for the Tupos LV/ATx was
performed.
Table 12 summarizes and compares the results from these
two clinical studies.
Table 12: Summary of Detection Times
Detection
Time
Tachos DR -
Atrial Tx ICD
Mean (SE) / N
Tupos
LV/ATx Mean
(SE) / N
Difference
Individual
Readings
2.27 (0.06) / 52
2.26 (0.06) /
71
0.01
By Patient 2.27 (0.07) / 26
2.24 (0.06) /
35
0.03
The analysis demonstrates that the average detection times
of the Tupos LV/ATx are comparable to the detection times
observed with the legally marketed Tachos DR - Atrial Tx
ICD. Both devices utilize identical ventricular detection
algorithms and only sense with the right ventricular lead. This
clinical data demonstrates that the ventricular detection times
are similar in both devices.
3. The purpose of Secondary Endpoint 3 is to evaluate the
percentage of ventricular pacing (thus, CRT) as
demonstrated by the device diagnostics at required follow-
ups. This data was based on diagnostic data stored by the
Tupos LV/ATx.
Table 13 summarizes the percentage of ventricular pacing
between follow-ups as shown by device diagnostics for
patients in the study group.