The Guardian was approved by the FDA in 2018 and launched in a
controlled manner in June, 2021
The ALERTS Study
The ALERTS study design evaluated the safety and efficacy of the
Guardian System. The ALERTS study was a prospective, randomized
multi-center study with FDA approval for 100 centers and 1020
subjects at high-risk of having recurrent acute coronary syndrome
(ACS) event.
The Guardian System was developed to provide patient alerting for
onset of ACS events, and detection of heart rate and rhythm
abnormalities.
Early Recognition and Treatment of STEMI
Implantable Cardiac Alert System for Early Recognition of ST-Segment Elevation Myocardial Infarction. Gibson CM, Holmes D, Mikdadi G, et al., (2019). Journal of the American College of Cardiology, 73(15), 1919–1927.
Decreased Pre-Hospital Delay
Implanted Monitor Alerting to Reduce Treatment Delay in Patients with Acute Coronary Syndrome Events. Holmes DR Jr, Krucoff MW, Mullin C, et al., (2019). Journal of the American College of Cardiology, 74(16), 2047–2055.
ALERTS Study
Rationale and design of the AngeLmed for Early Recognition and Treatment of STEMI trial: A randomized, prospective clinical investigation. Gibson MC, Krucoff M, Fischell D, et al., (2014). American Heart Journal, 168(2), 168–174.
Indications for Use
The Guardian is an implantable cardiac monitor with patient
alerting capability and an additional external alarm device. 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.
The Guardian System is indicated as an adjunct to patient
recognized symptoms. The Guardian System detects potential ongoing
ACS events, characterized by sustained ST segment changes, and
alerts the patient to seek medical attention for those potential
ACS events.
A Guardian System alert is a more accurate predictor of ACS events
when compared to patient recognized symptoms alone and
demonstrates a reduced rate over time of patient presentations
without ACS events (false positives) when compared to patient
recognized symptoms alone.
In the absence of symptoms, the Guardian System may identify
asymptomatic ACS events and prompt the patient to seek medical
attention.
The Guardian System is contraindicated in:
1
Patients with cognitive impairment that would prevent recognition of alarms
2
Patients who cannot feel the vibration from the IMD
3
Patients with implanted pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy devices
4
Patients where a pacemaker lead cannot be placed safely
