BIOTRONIK Evia DR, Technical Manual

Page: 43 / 183

Evia Technical Manual 35
The gender distribution in this clinical investigation is consistent
with other clinical studies and includes a representative
proportion of female participants. There were also no significant
differences found between high and low volume implant centers
in either the safety or effectiveness endpoints.
In accordance with the above conclusions, the clinical data
provides assurance that the ACC feature is safe and effective for
the treatment of conditions requiring chronic cardiac pacing as
specified in Section 2, Indications for Use.
6.3 Closed Loop Stimulation (CLS)
Three clinical studies were utilized to support the safety and
effectiveness determination of the CLS portion of the Cylos
family of pulse generators:
1. The Protos DR/CLS ER study provides information on
the response of CLS to acute mental stress
(
Section 6.3.1
).
2. The Protos DR/CLS AxVx study provides information on
the response of CLS to physical activity using the most
current version of CLS rate-adaptation (
Section 6.3.2).
3. The Inos family of pulse generators is an earlier
generation of BIOTRONIK devices. The CLS AxVp
portion of the Protos family of pulse generators is based
upon a study of the Inos pulse generators that focused
on response to physical activity (
Section 6.3.3
).
6.3.1 Protos DR/CLS Response to Mental
Stress
6.3.1.1 Primary Objectives
Demonstrate that CLS exhibits an appropriate heart rate
response to acute mental stress. This hypothesis was based on
administration of the ER Test© which was designed to elicit an
increase in heart rate by means other than physical activity.