| Device |
system, endovascular graft, arteriovenous (av) dialysis access circuit stenosis treatment |
| Definition |
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. |
| Physical State |
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. |
| Technical Method |
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. |
| Target Area |
Stenotic lesions or thrombotic occlusions in the arteriovenous dialysis access circuit, including the venous anastomosis. |
| Review Panel |
Cardiovascular |
|---|
| Product Code | PFV |
|---|
| Premarket Review |
Office of Cardiovascular Devices
(OHT2)
Circulatory Support, Structural and Vascular Devices
(DHT2B)
|
| Submission Type |
PMA
|
|---|
| Device Class |
3
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| Implanted Device? |
Yes
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Recognized Consensus Standards
|
| Third Party Review |
Not Third Party Eligible |
