Device Category Dossier

Drug-eluting coronary artery stent, non-biodegradable-polymer-coated

Device Category Dossier for Drug-eluting coronary artery stent, non-biodegradable-polymer-coated. Australian ARTG records, sponsors, device class —…

Device: XIENCE Skypoint Everolimus Eluting Coronary Stent System - Drug-eluting coronary artery stent, non-biodegradable-polymer-coated
Device: XIENCE Alpine Everolimus Eluting Coronary Stent System - Drug-eluting coronary artery stent, non-biodegradable-polymer-coated
Device: XIENCE PRIME Everolimus Eluting Coronary Stent System - Drug-eluting coronary artery stent, non-biodegradable-polymer-coated
Device: Onyx Frontier, Zotarolimus-Eluting Coronary Stent System - Drug-eluting coronary artery stent, non-biodegradable-polymer-coated
Device: Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System - Drug-eluting coronary artery stent, non-biodegradable-polymer-coated
Device: Promus ELITE Everolimus-Eluting Platinum Chromium Coronary Stent System - Drug-eluting coronary artery stent, non-biodegradable-polymer-coated
Device: XIENCE Sierra Everolimus Eluting Coronary Stent System - Drug-eluting coronary artery stent, non-biodegradable-polymer-coated
Device: Xience Xpedition Everolimus Eluting Coronary Stent System - Drug-eluting coronary artery stent, non-biodegradable-polymer-coated
Device: Xience Prime SV Everolimus Eluting Coronary Stent System - Drug-eluting coronary artery stent, non-biodegradable-polymer-coated
Device: XIENCE Prime LL Everolimus Eluting Coronary Stent System - Drug-eluting coronary artery stent, non-biodegradable-polymer-coated

Everolimus-eluting coronary stents are permanently implanted devices intended to improve coronary luminal diameters of either single or multiple vessels as an adjunct to coronary interventions and to reduce restenosis. These stents are used to treat patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions and to restore coronary flow in patients experiencing acute myocardial infarction who present within twelve hours of symptom onset.