کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
5592772 | 1405037 | 2016 | 6 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
The AngelMed Guardian system: Is there a role for implantable devices for early detection of coronary artery occlusion?
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کلمات کلیدی
موضوعات مرتبط
علوم زیستی و بیوفناوری
بیوشیمی، ژنتیک و زیست شناسی مولکولی
پزشکی مولکولی
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چکیده انگلیسی
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.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Cardiovascular Revascularization Medicine - Volume 17, Issue 8, December 2016, Pages 522-527
Journal: Cardiovascular Revascularization Medicine - Volume 17, Issue 8, December 2016, Pages 522-527
نویسندگان
Toby Rogers, Arie Steinvil, Rebecca Torguson, Ron Waksman,