CAUTION - Investigational Device.
Limited by United States law to investigational use.

The AngelMed Guardian® system consists of the following major components:

IMD (Implantable Medical Device): Model AG101 An implanted device which is designed to detect, analyze and store the patient’s electrogram waveforms and other crucial heart-signal data. The IMD vibrates to warn the patient of alarms and alerts.
EXD (External Device): Model EXD001 A hand-held telemetry device that is engineered to warn the patient of alarms and alerts via beeps and flashing LEDs.  The EXD is also used for communication between the Programmer and the IMD; transmitting vital cardiac information from the IMD to the Programmer.
Programmer A workstation used by the physician to configure the IMD and, when desired, retrieve data from the IMD.  It uses the EXD plug-in and long range telemetry technology to communicate with the patient's IMD.

The context of the above components is illustrated in the following system configuration figure:

The AngelMed Guardian IMD is implanted in the same manner as a pacemaker.  The IMD is designed to recognize a potential heart attack by detecting a shift in the ST segment level of a patient's electrogram sensed using a standard pacemaker lead.  The ST segment level is continually compared to the normal patient electrogram using a patented Angel Medical Systems detection algorithm.