The medium term results of a first-in-man structured registry have shown that Spiral Flow Grafts enhance treatment for patients with peripheral artery disease. The study is due to be published in the October issue of the Annals of Vascular Surgery.
The study authored by Peter A Stonebridge, Division of Cardiovascular Research, Ninewells Hospital and Medical School, University of Dundee, Dundee, Scotland, and others, assessed the safety and medium-term patency performance of a new graft which uses spiral laminar flow technology‰Û¥developed by Vascular Flow Technologies‰Û¥to induce stable laminar •Ââow through the distal anastomosis. The results have shown patient outcomes equivalent to, or exceeding, any known prosthetic grafts, including Heparin bonded grafts
In the study, 40 patients who required an infrainguinal bypass graft were recruited from 10 centres in Belgium and The Netherlands. Thirty-nine received a Spiral Laminar Flow graft as part of a standard treatment protocol (23 above-the-knee and 16 below-the-knee bypasses).
The 12-, 24-, and 30-month primary patency rates were 86%, 81%, and 81% for above-the-knee bypasses and 73%, 57%, and 57% for below-the-knee bypasses, respectively. In the case of secondary patency rates, numbers were unchanged for above-the-knee bypasses and were 86%, 64%, and 64%, respectively, for below-the-knee bypasses. There were no amputations in the study population.
“We are very pleased to see this high quality study published in a prestigious journal and are encouraged by the key findings within the paper. It is clear that Spiral Flow Grafts enhance patient outcomes. We will continue to develop more clinical experience and data sets and look forward to wider awareness of the true impact of our Spiral Flow products on patients’ lives,” said Bill Allan, CEO, Vascular Flow Technologies.