Device Dossier

BioMime™ - Sirolimus Eluting Coronary Stent System - Drug-eluting coronary artery stent, biodegradable-polymer-coated

Device Dossier for BioMime™ - Sirolimus Eluting Coronary Stent System - Drug-eluting coronary artery stent, biodegradable-polymer-coated (Drug-eluting…

Intended purpose

BioMime™ - Sirolimus Eluting Coronary Stent System is intended to be used in the coronary arteries for improving the coronary luminal diameter.

Functional description

Biomime Sirolimus Eluting Coronary Stent System comprises of a balloon expandable Sirolimus Eluting Cobalt ChromiumL605 stent mounted on rapid exchange PTCA balloon dilatation catheter. The PTCA balloon catheter serves as the stent delivery system that delivers and deploys the stent to the target site. The drug coated on the stent i.e. Sirolimus modulates inflammatory cell function and blocks smooth muscle cell proliferation.

TGA Public Summary