Vascular Flow Technologies Announces STAAR Registry of Spiral Flow AV Grafts

June 17, 2015—Vascular Flow Technologies announced a new observational registry for Spiral Flow arteriovenous (AV) grafts in hemodialysis access that will be conducted by the Society for Vascular Surgery Patient Safety Organization as part of their ongoing Vascular Quality Initiative. The Vascular Quality Initiative is designed to improve vascular health care and provides an opportunity for individual providers, hospitals, and regional quality improvement groups to collect and analyze clinical data in an effort to improve patient care.

According to the company, the Society for Vascular Surgery Patient Safety Organization evaluation will objectively measure the long-term safety, efficacy, and cost-effectiveness of the Spiral Laminar Flow AV graft when used as the primary access for patients with end-stage renal disease requiring routine hemodialysis. By restoring natural blood flow and eliminating turbulence that can lead to neointimal hyperplasia, Spiral Flow AV grafts may result in higher patency rates and fewer interventions when compared to other commercially available grafts. The company’s Spiral Laminar Flow technology is used to replicate natural blood flow for enhanced patient outcomes.

The Spiral Flow Technology AV Access Registry (STAAR) will be conducted at up to 15 participating centers in the United States and will enroll up to 75 patients with end-stage renal disease who require synthetic graft placement for hemodialysis access. Patients will be followed for a period of up to 12 months after graft implantation.

The implanted Spiral Flow AV graft will be assessed for primary patency (intervention-free access survival), assisted primary patency (thrombosis-free access survival), and secondary patency (access survival until abandonment), as well as any complications that arise during that time.