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Overview

The AngelMed Guardian® system is an implantable cardiac device, designed to detect rapid ST segment changes - ST shifts - that may signify major cardiac events, such as coronary artery occlusions caused by life-threatening vulnerable plaque ruptures. Once an ST shift is detected, the system is designed to alert patients to seek medical care by delivering a series of vibratory, auditory, and visual warnings.

The AngelMed Guardian system is intended to address the challenge of patients not recognizing nor responding quickly to heart attacks. The system, currently commercially available in Brazil, is the subject of a phase-II clinical study in the US: ALERTS.

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Components

The AngelMed Guardian System is designed to detect and then alert patients to the early warning signs that may indicate a serious ischemic event. Note that the system has not yet been proven to perform these functions.

Guardian AG101 IMD Guardian EXD Guardian Programmer
Implantable device (IMD)
Model AG101
Designed to:
  • Detect, analyze, and record crucial heart signal data
  • Vibrate to alert patients of cardiac events
  • Track ST deviations vs. heart rate for up to 6 months
  • Provide strong safety profile with minimal physician training
 External device (EXD)
Model EXD-001
Engineered to:
  • Provide additional auditory and visual alerts to patients
  • Transmit vital cardiac information from IMD to Programmer
  • Provide long-range telemetry from implant site
  • Control alerts with silence buttom


 Programmer (Physician workstation)
Model Prog-002
Developed to:
  • Program and retreive data from the IMD using EXD with long-range telemetry
  • Optimize display and analysis of patient data, including ECG signals, histograms, and other statistics
Caution: Investigational Device. Limited by United States law to investigational use.