The US Food and Drug Administration (FDA) has approved the Fluency Plus Endovascular Stent Graft from Bard for the treatment of in-stent restenosis in the venous outflow of haemodialysis patients dialysing by either an arteriovenous fistula or access graft.
Fluency Plus is a self-expandable, flexible, nitinol stent lined with an ePTFE graft and is indicated to open up a new blockage in a previously placed stent on the venous side of the dialysis access circuit. The device was approved by the FDA on 17 June 2014.
There device presents with four radiopaque tantalum markers on each end of the nitinol stent, facilitating stent graft placement by enhancing visibility under fluoroscopy. The nitinol stent is encapsulated with ePTFE along the entire length, except the flared stent graft ends with the radiopaque tantalum markers.
The stent graft is available in a range of diameters (6–13.5mm outer diameter) and lengths (40–120mm).
The Fluency Plus Vascular Stent Graft has been commercially available outside the United States since June 2005 with a vascular indication (iliac and femoral arteries). The Fluency Plus Biliary Stent Graft has been available in Japan since April 2009.
The approval was based on the results of a randomised, prospective, multicentre clinical trial that demonstrated that the Fluency Plus Endovascular Stent Graft was superior to the percutaneous transluminal angioplasty control with respect to six-month access circuit primary patency, the primary effectiveness endpoint, and no different than the angioplasty control with respect to safety.