Device Dossier

Multiple peripheral arteries stent

Device Dossier for Multiple peripheral arteries stent (Multiple peripheral arteries stent, Class IIb, sponsor Device Technologies). ARTG record, intended…

Intended purpose

For treatment of atherosclerotic disease of peripheral arteries to improve blood flow and maintain patency. Vascular Indications - Peripheral arterial occlusion disease - Strong Claudicatio intermittens - Critical ischaemia extremities - Dissections - Stenosis - Residual stenosis after balloon dilatations - Elastic stenosis post-bypass vascular anastomoses - Vascular occlusions - Insufficient angioplasty result Is not intended for use in the central circulatory system. [It is not intended for use in contact with the common iliac artery.] May also be used for implantation for maintenance and to restore bile flow of obstruction, stricture and stenosis of the bile ducts, caused by e.g. inflammation and/or tumour.

TGA Public Summary