Device Dossier

Zilver Flex Vascular Stent - Multiple peripheral arteries stent

Device Dossier for Zilver Flex Vascular Stent - Multiple peripheral arteries stent (Multiple peripheral arteries stent, Class III, sponsor William A…

Intended purpose

The device is intended for use in the iliac, superficial femoral artery and above-the-knee popliteal artery for the treatment of arteriosclerotic stenosis, and total occlusions that have been recanalized. The device provides mechanical support to maintain constant blood flow of the vessel.

Functional description

The device is a self-expandable stent made of Nitinol. The special laser-cut pattern of the Nitinol tube provides a construction with strong radial force and high flexibility. The tube is slotted and is designed to provide support while maintaining flexibility in the vessel upon deployment. Post-deployment the stent is designed to impart an outward radial force upon the inner lumen of the vessel, establishing patency in the stented region, thereby maintaining constant blood flow in the vessel.

TGA Public Summary