The AngelMed Guardian system: Is there a role for implantable devices for early detection of coronary artery occlusion?. [Review]

MedStar author(s):
Citation: Cardiovascular Revascularization Medicine. 17(8):522-527, 2016 DecPMID: 27847262 Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Journal Article | ReviewSubject headings: *Coronary Occlusion/di [Diagnosis] | *Electrophysiologic Techniques, Cardiac/is [Instrumentation] | *Monitoring, Ambulatory/is [Instrumentation] | *Transducers | Aged | Controlled Clinical Trials as Topic | Coronary Occlusion/pp [Physiopathology] | Device Approval | Early Diagnosis | Electrophysiologic Techniques, Cardiac/ae [Adverse Effects] | Equipment Design | Female | Humans | Male | Middle Aged | Monitoring, Ambulatory/ae [Adverse Effects] | Patient Safety | Predictive Value of Tests | Prognosis | Public Opinion | Risk Factors | United States | United States Food and Drug AdministrationYear: 2016Local holdings: Available in print through MWHC library: 2002 - presentISSN:
  • 1878-0938
Name of journal: Cardiovascular revascularization medicine : including molecular interventionsAbstract: Copyright © 2016 Elsevier Inc. All rights reserved.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.All authors: Rogers T, Steinvil A, Torguson R, Waksman RFiscal year: FY2017Digital Object Identifier: Date added to catalog: 2017-04-10
Holdings
Item type Current library Collection Call number Status Date due Barcode
Journal Article MedStar Authors Catalog Article 27847262 Available 27847262

Available in print through MWHC library: 2002 - present

Copyright © 2016 Elsevier Inc. All rights reserved.

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.

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