The AngelMed Guardian®
The AngelMed Guardian is an implantable monitoring device that may benefit those suffering from high-risk Acute Coronary Syndrome (ACS) events.
The AngelMed Guardian is more accurate than patient recognised symptoms and even alerts in the complete absence of symptoms, giving increased peace of mind to those who have experienced a prior ACS event.
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It's about time
The AngelMed Guardian’s operation is based on the well understood and documented relationship between ST-segment changes and ischaemia.
The AngelMed Guardian continuously monitors the patient’s heart signal for ST-segment changes and provides notification using triple-modality alerting when an abnormal change occurs.
The abnormal change is measured by “ST-Shift” which is the difference between the patient’s current ST-segment and what is normal for that patient over the last 24-hours.
Upon detection of a cardiac event the patient receives a vibration alert from the implanted monitor, plus auditory and visual alerts from the external pager-like device. The patient or their carer is responsible for calling an ambulance. Once at the hospital they can be diagnosed by following the normal ACS protocol and treated as required.
Early detection and alerting reduces pre-hospital delay and may reduce the amount of myocardial damage that occurs due to the reduction or cessation of blood flow caused by a coronary artery blockage.
Implanting the IMD
The technique used to implant the AngelMed Guardian’s IMD is identical to that employed when implanting a single chamber ventricular pacemaker, the exception being the patient population.
Qualifying patients for the AngelMed Guardian will have had a prior ACS event, but will not have a conduction disorder.
An active fixation transvenous pacing lead is implanted in the apex of the right ventricle and then attached to the IMD in the same manner as a pacemaker. The IMD is then placed in a pocket and the wound closed.
Following implantation, the AngelMed Guardian is set to collect data over a two-week period. At the end of the two-weeks the patient meets with their physician and personalised ST-segment trending parameters and a matching alarm configuration are created.
The AngelMed Guardian 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.
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
Implantation safety profile similar to single chamber pacemakers
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
Wizard-enabled programming of the implanted cardiac monitor
Displays and analyses patient cardiac data including long-term histograms, trend data and summary statistics
Stores raw endocardial electrogram records to facilitate quick assessment of the patient’s cardiac waveform history to look for recent changes
Frequently asked questions
The AngelMed Guardian does not pace your heart. Its function is to evaluate your heart every 90 seconds and alert you at the onset of an acute coronary syndrome (ACS) event.
The value of continuous cardiac monitoring is simple: getting patients to the emergency room without unnecessary delay leads to better outcomes.
The AngelMed Guardian:
- can alert you to an acute coronary syndrome (ACS) event even if you do not have any symptoms
- has been shown to have a higher accuracy of detecting an ACS event than symptoms alone
- has been shown to decrease the rate of incorrect and unmerited visits to the emergency room since patients do not worry about “minor” or transitory symptoms
- can allow patients to perform cardiac rehabilitation and exercise according to their doctors recommendations while knowing their heart is being monitored
- can alert patients who have angina (i.e. who have symptoms regularly) that an event has been detected and they should go to the emergency room
The AngelMed Guardian 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.
If a patient already has a device that is prescribed to administer therapy they cannot receive the AngelMed Guardian.
Further Information for Healthcare Professionals
Holmes, D.R. et al. Implanted Monitor Alerting to Reduce Treatment Delay in Patients With Acute Coronary Syndrome Events 2019. J Am Coll Cardiol; 74(16):2047-55
Gibson, C.M. et al. Implantable Cardiac Alert System for Early Recognition of ST-Segment Elevation Myocardial Infarction 2019. J Am Coll Cardiol; 73(15):1919-27
Gibson, C.M. et al. Rationale and design of the AngelMed for Early Recognition and Treatment of STEMI trial: a randomized, prospective clinical investigation 2014. American Heart Journal; 168(2):168-74.
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