Device Dossier
BeGraft Stent Graft System - Peripheral artery endovascular stent-graft, non-medicated
Device Dossier for BeGraft Stent Graft System - Peripheral artery endovascular stent-graft, non-medicated (Peripheral artery endovascular stent-graft,…
- GMDN category: Peripheral artery endovascular stent-graft, non-medicated
- Sponsor: Device Technologies
Intended purpose
The BeGraft 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 fenestrated aortic endovascular graft, thus keeping the visceral arteries perfused.
Functional description
The BeGraft Stent Graft System consists of a cylindrical, balloon-expandable stent graft, composed of a cobalt-chromium (L-605)stent, covered with ePTFE graft material, which is pre-mounted on the balloon of an OTW delivery system. The delivery system is a 0.035” PTA dual lumen dilatation catheter with a balloon at the distal end. Two radiopaque platinum / iridium markers located underneath the balloon identify the position of the stent graft and mark the working length of the balloon.