Patient presents with a GUARDIAN™ EMERGENCY ALARM or Ischemic Symptoms:

PROTOCOL: Patient should undergo all exam/procedures per the facility and local standard of care for chest pain or possible ACS event.

MRI Procedures

Patient should avoid MRI procedures.

What is the GUARDIAN implant?

GUARDIAN is a diagnostic device for ACS events—does not shock (ICD) or pace (pacemaker)

Device alarms when it detects possible acute coronary syndrome (ACS) events or cardiac events.

Device may alarm even if patient has NO obvious cardiac symptoms.

Device may NOT alarm even with obvious cardiac symptoms.

What is The GUARDIAN System?

An implantable cardiac monitoring device (IMD) designed to detect acute ST segment changes and warn patients to seek prompt medical attention when they occur.

A hand-held external audio/visual device (EXD), which is carried by the patient and serves as a secondary notification device.

Implantable Medical Device (IMD)

MODEL AMSG3-E

Records and analyses heart signal data to detect ACS events

Vibrates to alert patient to an ACS event

Tracks ST-segment data and heart rate for up to six months

Implant safety profile similar to single chamber pacemakers

External Device (EXD)

MODEL EXD-001

Provides additional auditory and visual alerts to patients

Transmits vital cardiac information from IMD to Programmer

Provides patient control to silence primary and secondary alarms

Watch a GUARIAN System Overview Video

The GUARDIAN™ System is indicated for use in patients who have had prior acute coronary syndrome (ACS) events and who remain at high risk for recurrent ACS events.

GUARDIAN is indicated as an adjunct to patient recognized symptoms. GUARDIAN detects potential ongoing ACS events, characterized by sustained ST segment changes, and alerts the patient to seek medical attention for those potential ACS events.

GUARDIAN is contraindicated in: patients with cognitive impairment that would prevent recognition of alarms; patients who cannot feel the vibration from the IMD; patients with implanted pacemaker, implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) devices; patients where a pacemaker lead cannot be placed safely.

GUARDIAN is available by prescription or order of a physician only in the USA. For additional information, please contact sales@avertix.com.