FLUENCY® PLUS Endovascular Stent Graft 6 mm x 120 mm (80 cm delivery system)

FLUENCY® PLUS Endovascular Stent Graft 6 mm x 120 mm (80 cm delivery system)
Fluency® Endovascular Stent Graft - FEM06120

A non-bioabsorbable tubular device designed to be implanted in a central or peripheral vein (e.g., subclavian, brachiocephalic) to maintain vessel lumen patency, typically to treat stenosis in the outflow of an arteriovenous fistula (AVF) or graft used for haemodialysis. It is a mesh structure made of metal [e.g., nickel-titanium alloy (Nitinol)] that is covered with a synthetic polymer [e.g., polytetrafluoroethylene (ePTFE)] membrane (endovascular graft), and contains an inner carbon coating to help prevent platelet adhesion. It is typically expanded in situ (e.g., self-expands or balloon-expandable) and disposable devices associated with implantation may be included.

• Implant Diameter,6 Millimeter
• Implant Length,120 Millimeter
• Catheter Length,80 Centimeter

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: PFV

Device Name: System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

Device Class: 3

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.

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.

Submission Type ID: 2

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: 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.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: Stenotic lesions or thrombotic occlusions in the arteriovenous dialysis access circuit, including the venous anastomosis.

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Id: 04049519008424

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A