UK-based medical device firm Vascular Flow Technologies (VFT) has revealed the results of the study that demonstrated better primary patency rates for its Spiral Flow arteriovenous (AV) graft compared to polytetrafluoroethylene (PTFE) graft.
Designed for haemodialysis, SLF graft midterm results of the first European series have been presented at the Vascular Access Society meeting in Barcelona, Spain.
According to the company, the 18-month independent study demonstrated primary patency rates of 72% for Spiral Flow AV graft compared to 36.7% for PTFE grafts.
The study investigator and Austria-based Feldkirch General Hospital vascular surgery department Dr Wolfgang Hofmann said: "The results are more than satisfactory, particularly as the patients receiving Spiral Flow grafts were negatively selected."
The study is said to compare primary patency rates for 15 patients receiving Spiral Flow AV grafts, with a consecutive series of 87 patients receiving PTFE grafts.
Spiral Flow AV grafts have been only used, if patients were not suitable for any type of autologous fistula, according to pre-operative duplex mapping.
There were four shunt occlusions, of which two were managed by thrombectomy, out of the 15 patients receiving Spiral Flow AV grafts.
Calculated by Kaplan Meier, primary patency at 18 months for Spiral Flow AV grafts was 72% and secondary patency was 85.5%.
VFT noted that the study results provide strong support for the premise of VFT’s Spiral Flow technology and Spiral Flow grafts are designed to encourage a spiral laminar flow within the graft that replicates the natural flow in blood vessels.