||system, endovascular graft, arteriovenous (av) dialysis access circuit stenosis treatment|
||An endovascular graft for av dialysis access is a stent graft intended for the revision of arteriovenous access circuits to maintain or re-establish vascular access (treat stenotic lesions or thromboic occlusions) for hemodialysis.
||The endovascular stent-graft is a metal scaffold covered with fabric material. The stent-graft is placed via a delivery catheter into the arteriovenous dialysis access circuit to maintain or re-establish vessel patency for hemodialysis. The endovascular stent-grafts are available in various diameters and lengths.
||Generally, a Peripheral Transluminal Angioplasty (PTA) catheter is used initially to open up the occlusion and allow for passage of the endovascular graft delivery system to pass through. The endovascular graft is then deployed at the site of the occlusion with the structural stent component propping open the vessel. The covered stent assists in maintaining vessel patency post-procedure.
||Stenotic lesions or thrombotic occlusions in the arteriovenous dialysis access circuit, including the venous anastomosis.
Office of Device Evaluation
Division of Cardiovascular Devices
Vascular Surgery Devices Branch (VSDB)
|Total Product Life Cycle (TPLC)
TPLC Product Code Report
|Third Party Review
||Not Third Party Eligible