Device Dossier

BIOMONITOR IV - Implantable cardiac monitor

Device Dossier for BIOMONITOR IV - Implantable cardiac monitor (Implantable cardiac monitor, Class III, sponsor Biotronik). ARTG record, intended…

Intended purpose

BIOMONITOR IV is an implantable cardiac monitor intended to: - Detect cardiac rhythm disturbances and monitor their occurrence and frequency in diseases involving brady/tachyarrhythmias, asystoles, sudden cardiac rate drops, as well as rhythm recordings triggered by the patient experiencing symptoms - Monitor patient activity and body temperature trend The implantable cardiac monitor achieves its intended purpose by detection, analysing and subsequent recording of subcutaneous ECGs and additional long-term diagnostic data.

Functional description

BIOMONITOR IV continuously and automatically records and monitors the heart rhythm. Depending on preset parameters, subcutaneous ECGs and other data may be recorded. The patient can also trigger the recording of subcutaneous ECGs using the Remote Assistant III accessory if subjectively symptomatic episodes occur. Recordings can be transmitted to the BIOTRONIK Home Monitoring Service Center, enabling physicians to perform complete diagnosis management. MR conditional.

TGA Public Summary