title: The AngelMed Guardian system: Is there a role for implantable devices for early detection of coronary artery occlusion?
abstract: The AngelMed Guardian System is an implantable device similar to a single chamber pacemaker that continuously monitors the intracardiac electrogram for evidence of ST segment shift indicating acute coronary artery occlusion. The system aims to reduce time to presentation by alerting patients to present to a medical facility whether symptoms are present or not. In March 2016, the US Food and Drug Administration (FDA) assembled a meeting of the Circulatory System Devices Panel to review the results of the AngelMed for Early Recognition and Treatment of STEMI (ALERTS) pivotal trial and the accompanying premarket approval (PMA) application for regulatory approval of the AngelMed Guardian System in the US. In this review, we examine the ALERTS trial methodology and results, and describe the FDA panel's deliberations and recommendations.
authors.affiliation: Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, USA.
authors.forename: Toby
authors.initials: T
authors.lastname: Rogers
authors.affiliation: Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, USA.
authors.forename: Arie
authors.initials: A
authors.lastname: Steinvil
authors.affiliation: Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, USA.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Torguson
authors.affiliation: Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, USA. Electronic address: Ron.waksman@medstar.net.
authors.forename: Ron
authors.initials: R
authors.lastname: Waksman
mesh_terms: D000368:Aged; D018849:Controlled Clinical Trials as Topic; D054059:Coronary Occlusion / Q000175:diagnosis* / Q000503:physiopathology; D018795:Device Approval; D042241:Early Diagnosis; D022062:Electrophysiologic Techniques, Cardiac / Q000009:adverse effects / Q000295:instrumentation*; D004867:Equipment Design; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D018670:Monitoring, Ambulatory / Q000009:adverse effects / Q000295:instrumentation*; D061214:Patient Safety; D011237:Predictive Value of Tests; D011379:Prognosis; D011639:Public Opinion; D012307:Risk Factors; D014159:Transducers; D014481:United States; D014486:United States Food and Drug Administration
keywords: Acute coronary syndrome; Early recognition; FDA; Silent myocardial infarction