Advanta V12 Covered Stent System - Peripheral artery endovascular stent-graft, non-medicated

Intended purpose

The Advanta V12 covered stent system is intended to restore and improve the patency of the renal and/or aortic iliac arteries, when endovascular therapy is required. The Advanta V12 covered stent system is intended to preserve flow to celiac, superior mesenteric, and/or renal arteries when used as a bridging stent between a branch vessel and endovascular graft in fenestrated or branched endovascular aortic repair (FEVAR or BEVAR). The Advanta V12 covered stent system is intended to preserve flow when used as a bridging stent between an internal iliac artery with an iliac branch device (IBD). Use in renal arteries is limited to 5 mm, 6 mm, and 7 mm diameter sizes. Use in EVAR and IBD is limited to 5-10 mm diameter sizes.

Functional description

A single-use balloon expandable stent, made of 316L stainless steel and encapsulated with expanded PTFE (ePTFE). The delivery system comprises an over-the-wire (OTW) catheter with a non-compliant balloon. The device is available in diameters of 5 mm to 10 mm and crimped lengths of 16 mm, 22 mm, 32 mm, 38 mm, and 59 mm, depending on diameter. The delivery system is compatible with a 0.035in. (0.89 mm) guidewire and has a usable length of 80 cm or 120 cm.