Device Dossier

Evermine50 Everolimus Eluting Coronary Stent System - Drug-eluting coronary artery stent, biodegradable-polymer-coated

Device Dossier for Evermine50 Everolimus Eluting Coronary Stent System - Drug-eluting coronary artery stent, biodegradable-polymer-coated (Drug-eluting…

Intended purpose

Evermine50 Everolimus Eluting Coronary Stent System is intended to be used in the coronary arteries for improving the coronary luminal diameter.

Functional description

Evermine50™ is a drug eluting, balloon expandable cobalt chromium L605 stent mounted on a rapid exchange PTCA balloon dilatation catheter. The PTCA balloon dilatation catheter serves as the stent delivery system that delivers and deploys the stent at a target site. The balloon is inflated by hydraulic pressurization using appropriate inflation medium. The mounted stent expands due to balloon inflation and is deployed at target site. The stent remains expanded after deflation of the balloon.

TGA Public Summary