Device Dossier
BeFlared FEVAR Stent Graft System - Peripheral artery endovascular stent-graft, non-medicated
Device Dossier for BeFlared FEVAR Stent Graft System - Peripheral artery endovascular stent-graft, non-medicated (Peripheral artery endovascular…
- GMDN category: Peripheral artery endovascular stent-graft, non-medicated
- Sponsor: Device Technologies
Intended purpose
The BeFlared FEVAR Stent Graft System is intended to be used as a bridging stent graft in combination with a fenestrated aortic endovascular graft, thus keeping the visceral arteries perfused.
Functional description
The BeFlared FEVAR Stent Graft System consists of a balloon-expandable cobalt-chromium stent, covered with ePTFE, 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. Three radiopaque markers located under the balloon identify the stent position on the delivery system, mark the working length of the balloon and aid in positioning in the fenestration of the aortic endovascular graft.