Technology | Implantable Cardiac Monitor (ICM) | May 09, 2018

FDA Clears Implantable Heart Attack Warning Device

AngelMed Guardian System monitors a patient's heart's electrical activity for changes that may indicate the heart is not getting enough oxygen

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

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

The Angel Medical Systems' AngelMed Guardian System system components.

The Angel Medical Systems' AngelMed Guardian System system components.

 May 9, 2018 — The U.S. Food and Drug Administration (FDA) said it recently granted market clearance for Angel Medical Systems' AngelMed Guardian System, an implantable cardiac monitor intended to detect and alert patients of a potential heart attack. 

The system consisting of three components: an implantable medical device (IMD), an external device (EXD) and the programmer collecting and storing information about the patient's heart electrical activity. The IMD, which monitors the heart's electrical activity (electrograms) and alerts a patient with vibrations if it detects a potential heart attack. The EXD alerts the patient of an 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 Guardian 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 system 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 Guardian 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 IMD of the AngelMed Guardian System should not be implanted in patients with cognitive impairment that would prevent recognition of alarms, patients who cannot feel the vibration from the IMD, or patients with an implanted pacemaker, implantable cardioverter defibrillator, or cardiac resynchronization therapy devices. It is also contraindicated for patients where a pacemaker lead cannot be placed safely.

Read the FDA approval letter.

Read the summary of safety and effectivness from the FDA.

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