Device Category Dossier

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

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

Drug-eluting coronary stents are implantable devices placed in coronary arteries to improve coronary luminal diameter , incorporating drug substances such as sirolimus that are eluted from the stent to prevent restenosis . These devices are used to treat patients with symptomatic ischemic heart disease caused by stenotic lesions in native coronary arteries , including applications in acute and chronic coronary syndromes, multivessel disease, and in-stent restenotic lesions .