Dundee, UK, 17 June, 2015 – Vascular Flow Technologies, the medical device company using proprietary Spiral Laminar Flow (SLF) technology to replicate natural blood flow for enhanced patient outcomes, today 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 (SVS PSO) as part of their ongoing Vascular Quality Initiative (VQI). The VQI 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.
The SVS PSO evaluation of Vascular Flow Technology’s Spiral Laminar Flow Arteriovenous Graft will objectively measure the long-term safety, efficacy and cost effectiveness when used as the primary access for patients with end stage renal disease (ESRD) 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 marketed grafts.
The Spiral flow Technology AV Access Registry (STAAR) will recruit up to 15 participating centers in the US and enroll up to 75 patients with ESRD who require synthetic graft placement for hemodialysis access. Patients will be followed for a period of up to 12 months following 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.
Dr. Barbara Bunger, Chief Clinical Officer for Vascular Flow Technologies, commented: “The STAAR post market registry will collect intraoperative and acute post-operative outcomes in addition to long term graft performance in real world clinical practice as patients undergo routine dialysis. We anticipate the resulting dataset to help confirm the hypothesis that Spiral Flow grafts have higher patency rates, and require fewer interventions than PTFE grafts resulting in lower costs to healthcare payers and healthcare providers.”
The SVS PSO Steering Committee will independently conduct and analyze the results of the STAAR under a prospectively designed protocol. An interim analysis will be performed when 25 subjects have completed 12 months of follow-up, and based on the projected patient recruitment rate, the full 12-month dataset will be available in 2017.
The SVS PSO STAAR registry is in addition to the Spiral Flow AV Access Graft Clinical Registry, which was announced in 2014 and is open to any interested surgeon. This open-access registry provides data to detailing graft performance data compared to national performance and can be accessed at www.vascular‐flow‐clinical‐registry.com.