Device Dossier

iVascular iCover - Peripheral artery endovascular stent-graft, non-medicated

Device Dossier for iVascular iCover - Peripheral artery endovascular stent-graft, non-medicated (Peripheral artery endovascular stent-graft,…

Intended purpose

iCover is intended to restore the internal diameter of arteries to improve blood flow in arterial disease.

Functional description

The device consists of a balloon-expandable ePTFE-covered stent pre-assembled on a OTW delivery system used in percutaneous transluminal angioplasty (PTA) procedures. The stent, designed to be used as a permanent implant, is made of a cobalt-chromium alloy (L605) fully encapsulated in expanded polytetrafluoroethylene (ePTFE). Each end of the stent includes 3 radiopaque Tantalum markers. The stent is designed for different artery diameters (5-10mm).

TGA Public Summary