Device Dossier

BeGraft Plus Stent Graft System - Peripheral artery endovascular stent-graft, non-medicated

Device Dossier for BeGraft Plus Stent Graft System - Peripheral artery endovascular stent-graft, non-medicated (Peripheral artery endovascular…

Intended purpose

The BeGraft Plus Stent Graft System is intended to be used for permanent intraluminal placement in iliac and renal arteries to restore and improve the patency and vessel anatomy, and as bridging stent graft in combination with a branched aortic endovascular graft, thus keeping the visceral arteries perfused.

Functional description

The BeGraft Plus Stent Graft System consists of a double-layer, ePTFE covered stent design, pre-mounted on the balloon of a delivery system. The delivery system provides deployment of the stent into the target area (lesion). After deployment, the delivery system is removed. The stent restores the blood flow of the artery, seals aneurysms, acute perforations, acute ruptures, and fistulas and further, creates a bridge between the branched aortic endovascular graft and the visceral arteries.

TGA Public Summary