Device Dossier
Supraflex Cruz Sirolimus Eluting Stent System - Drug-eluting coronary artery stent, biodegradable-polymer-coated
Device Dossier for Supraflex Cruz Sirolimus Eluting Stent System - Drug-eluting coronary artery stent, biodegradable-polymer-coated (Drug-eluting…
Intended purpose
The Supraflex Cruz™ sirolimus-eluting coronary stent system 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 in native coronary arteries with a reference vessel diameter from 2.00 mm to 4.50 mm.
Functional description
The SUPRAFLEX CRUZ Sirolimus-eluting coronary stent system consists of a balloon expandable Sirolimus-eluting stent, pre mounted on a stent delivery system. The Supraflex Cruz™ sirolimus-eluting coronary stent system is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due coronary artery lesions.