Device Dossier
Propaten Vascular Graft - Graft, vascular, synthetic
Device Dossier for Propaten Vascular Graft - Graft, vascular, synthetic (Graft, vascular, synthetic, Class III, sponsor W L Gore & Associates). ARTG…
- GMDN category: Graft, vascular, synthetic
Intended purpose
GORE® PROPATEN® Vascular Graft is indicated for patients who require replacement or bypass of peripheral vessels due to occlusive or aneurysmal diseases or trauma, or for patients who require arteriovenous hemodialysis access in the upper or lower extremities due to end-stage renal disease (ESRD). GORE® PROPATEN® Vascular Graft Configured for Pediatric Shunt is indicated for staged palliative repair of cyanotic congenital heart disease (CCHD).
Functional description
Expanded PTFE forms a base tube which is reinforced with a thin circumferential film to ensure a resistance to dilation sufficient for long term use in the body. It incorporates bioactive heparin in the lumen of the vascular graft.