BIOTRONIK Evia DR, Technical Manual

Page: 42 / 183

34 Evia Technical Manual
96.3%
89.1%
80%
85%
90%
95%
100%
Pre-discharge 3-Month
Figure 2. ACC Activation Rates
During the one-month follow-up, the ACC algorithm was tested
to determine the highest maximum ACC amplitude setting (from
2.4V to 6.4V) for which ACC can be successfully activated.
Table 6
provides the distribution of the highest maximum ACC
amplitudes successfully activated at the one-month follow-up
visit. A high percentage (88.9%) of patients can be safely
programmed at or above 4.8V where ACC remains activated.
Table 6: Highest Maximum ACC Amplitude Setting
Testing of Maximum ACC Amplitude Result
Number of tests completed
Highest Functional Maximum ACC Amplitude
2.4
Volts
3.6 Volts
4.8 Volts
6.4 Volts
99
4 (4.0%)
7 (7.1%)
15 (15.2%)
73 (73.7%)
6.2.4 Clinical Study Conclusions
The clinical data support the following conclusions regarding the
safety and efficacy of the ACC feature.
The Philos DR ACC Pacing System is safe and effective for use
in patients that are indicated for pacing therapy. The
Philos DR ACC Clinical Study fulfilled the predefined primary
safety and efficacy endpoints. These endpoints included safety
and effectiveness of the ACC feature.