BIOTRONIK Evia HF, Technical Manual, Page: 9 / 138

Chapter 1 Device Description
Evia HF / HF-T Technical Manual
PAGE 1
1. Device Description
Evia HF / HF-T is a multi-programmable, three chamber pulse generator with rate-adaptive pacing.
The Evia HF / HF-T pulse generator 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 HF / HF-T 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 HF-T 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.
With the TRUST study, BIOTRONIK was able to show the following with regards to Home Monitoring:
• BIOTRONIK Home Monitoring information may be used as a replacement for device interrogation
during in-office follow-up visits.
• A strategy of care using BIOTRONIK Home Monitoring with office visits when needed has been
shown to extend the time between routine, scheduled in-office follow-ups of BIOTRONIK
implantable devices in many patients. Home Monitoring data is helpful in determining the need for
additional in-office follow-up.
• BIOTRONIK Home Monitoring-patients—who are followed remotely with office visits when
needed—have been shown to have similar numbers of strokes, invasive procedures and deaths as
patients followed with conventional in-office follow-ups.
• BIOTRONIK Home Monitoring provides early detection of arrhythmias.
• BIOTRONIK Home Monitoring provides early detection of silent, asymptomatic arrhythmias.
• Automatic early detection of arrhythmias and device system anomalies by BIOTRONIK Home
Monitoring allows for earlier intervention than conventional in-office follow-ups.
• BIOTRONIK Home Monitoring allows for improved access to patient device data compared to
conventional in-office follow-ups since device interrogation is automatically scheduled at
regular intervals.
Evia HF / HF-T provides three chamber pacing in a variety of rate-adaptive and non-rate adaptive
pacing modes. Pacing capability is supported by a sophisticated diagnostic set.
The device is designed and recommended for use with atrial and ventricular unipolar or bipolar leads
having IS-1 compatible connectors. (Note that IS-1 refers to the International Standard whereby leads
and generators from different manufacturers are assured a basic fit [Reference ISO 5841-3:1992]).