Device Dossier
Orsiro Mission Sirolimus Eluting Coronary Stent System - Drug-eluting coronary artery stent, biodegradable-polymer-coated
Device Dossier for Orsiro Mission Sirolimus Eluting Coronary Stent System - Drug-eluting coronary artery stent, biodegradable-polymer-coated…
Intended purpose
Orsiro Mission is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de-novo stenotic lesions and in-stent restenotic lesions.
Functional description
A drug-eluting balloon-expandable stent (permanent implant) pre-mounted on a rapid-exchange PTCA catheter delivery system (usable length=140cm). 2 stent configurations: small & medium. Stent is made from cobalt chromium alloy (L-605), covered with a thin layer of amorphous silicon carbide. Stent body surface consists of a carrier (PLLA) & an active substance Sirolimus. Stent is positioned between 2 radiopaque markers located on delivery system used for fluoroscopic visualization. MR conditional.