BIOTRONIK Evia DR, Technical Manual

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Evia Technical Manual 1
1. Device Description
Evia is a multi-programmable, dual chamber pulse generator
with rate-adaptive pacing. The Evia family of pulse generators is
BIOTRONIK’s state of the art pacing system with two methods of
rate-adaptation. Rate-adaptation is achieved through
programming of either the unique principle of closed-loop
stimulation (CLS) or by motion-based pacing via a capacitive
accelerometer.
The basic function of CLS involves the translation of myocardial
contractility into patient-specific pacing rates. Specifically, the
pulse generator monitors and processes the intracardiac
impedance signals associated with myocardial contraction
dynamics. Changes in the waveform of this impedance signal
are associated with changes in the contraction dynamics of the
patient's heart due to the heart’s inotropic response to exercise
and acute mental stress. By monitoring these changes, the
pulse generator can provide a pacing rate that is appropriate and
specific to the patient’s individual physiologic demands due to
exercise and acute mental stress.
For standard motion-based rate-adaptation, the Evia is equipped
with an accelerometer located within the pulse generator. This
sensor produces an electric signal during physical activity of the
patient. If a rate-adaptive (R) mode is programmed, then the
accelerometer sensor signal controls the stimulation rate.
Evia also employs Home Monitoring™ technology, which is an
automatic, wireless, remote monitoring system for management
of patients with pulse generators. With Home Monitoring,
physicians can review data about the patient’s cardiac status
and pulse generator’s functionality between regular follow-up
visits, allowing the physician to optimize the therapy process.
BIOTRONIK conducted the TRUST study to evaluate the safety
and effectiveness of Home Monitoring. Refer to Section 6.4 for
details regarding the study design and results. With the TRUST
study, BIOTRONIK was able to show the following with regards
to Home Monitoring: