LUX-Dx II+ Insertable Cardiac Monitor - Implantable cardiac monitor

Intended purpose

The LUX-Dx Insertable Cardiac Monitor (ICM) is intended to monitor and record subcutaneous ECG (S-ECG) for the clinical evaluation and diagnosis of cardiac arrhythmias

Functional description

The insertable cardiac monitor is a small, leadless electronic device inserted just under the skin in the chest area. Its primary function is to monitor, record, and store data related to cardiac arrhythmias. The device uses two electrodes on the body of the device to monitor the patient’s subcutaneous ECG(SECG) data when specific arrhythmias are detected. In addition, the sensor will record S-ECG data when the patient initiates or triggers the device to record S-ECG.