Vascular Flow Technologies (Dundee, Scotland) has announced that it has received FDA clearance for its Spiral Laminar Flow™ arteriovenous (AV) graft portfolio (K252277).
The SLF™* AV graft is an ePTFE hemodialysis graft with a unique design feature on the venous end of the graft, which remodels the blood flow in a spiral laminar fashion.
The SLF™* AV Graft benefits patients by decreasing turbulent blood flow at the venous anastomosis, improving overall patency, while slowing the progression of venous neointimal hyperplasia (VNIH), which accounts for the overwhelming majority of ePTFE AV Graft failure.1, 2
“We are excited to bring a novel and innovative AV graft to the U.S. market,” said Craig Dunlop, General Manager of Vascular Flow, “This technology will be of great long-term benefit to people suffering from End Stage Renal Disease.”