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

详细信息    查看全文

• 作者：Toby Rogers ; Arie Steinvil ; Rebecca Torguson ; Ron Waksman ; ^{Ron.waksman@medstar.net}
• 关键词：Acute coronary syndrome ; Silent myocardial infarction ; Early recognition ; FDA
• 刊名：Cardiovascular Revascularization Medicine
• 出版年：2016
• 出版时间：December 2016
• 年：2016
• 卷：17
• 期：8
• 页码：522-527
• 全文大小：394 K
• 卷排序：17

文摘

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.