Implantable cardiac monitor gets FDA market approval

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The AngelMed Guardian System is an implantable cardiac monitor intended to detect and alert patients of a potential heart attack.

The Guardian System consists of three components:

  • The Implantable Medical Device (IMD), which monitors the heart’s electrical activity (electrograms) and alerts a patient with vibrations if it detects a potential heart attack.
  • The External Device (EXD) alerts the patient of a potential heart attack with alarms and lights letting the patient know to seek medical attention. Patients must have this part of the system with them in order to be alerted.
  • The programmer collects and stores information from the IMD about the patient’s heart electrical activity. The doctor can use this information to determine the best treatment option. The doctor can also use the programmer to configure the adjustable settings in the IMD.

The system monitors a patient’s heart’s electrical activity for changes that may indicate the heart is not getting enough oxygen and there is a potential for a heart attack. If the device detects those changes, the IMD will vibrate, and the EXD will flash light and alerts the patient to seek medical attention.

The monitor is indicated for use in patients who have had prior acute coronary syndrome (ACS) events (heart attack and unstable angina) and who remain at high risk for recurrent ACS events. The system’s alarm is intended to alert patients to seek medical care when there is a change in the patient’s heart’s electrical activity that could be indicative of a heart attack.

The system alerts patients to seek medical care when there is a change in the patient’s heart rhythm that could be indicative of a potential heart attack.

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