Device Dossier
BeGraft Peripheral Stent Graft System - Multiple peripheral arteries stent
Device Dossier for BeGraft Peripheral Stent Graft System - Multiple peripheral arteries stent (Multiple peripheral arteries stent, Class III, sponsor…
- GMDN category: Multiple peripheral arteries stent
- Sponsor: Device Technologies
Intended purpose
The BeGraft Peripheral Stent Graft System is indicated for intraluminal chronic placement in iliac and renal arteries for: • Restoring and improving the patency and • Treating aneurysms, acute perforations, acute ruptures and fistulas.
Functional description
The system consists of; a balloon-expandable cobalt-chromium (L605) stent, covered with an ePTFE graft material, which is pre-mounted on the balloon of an over the wire (OTW) stent delivery system. The Delivery System is compatible with 0.035” (0.89mm) guide wires and is available in usable lengths of 75cm and 120cm. Two radiopaque markers located underneath the balloon identify the BeGraft Peripheral Stent position and fluoroscopically mark the working length of the balloon.