Vascular Flow Technologies collaborates with SVS PSO and M2S® for a new post-market observational registry
Chicago, IL and West Lebanon, NH Jun 24, 2015 – The Society for Vascular Surgery® Patient Safety Organization and M2S, a leader in clinical registry development, today announced a new observational registry collaboration with Vascular Flow Technologies Ltd (UK). The SVS PSO Spiral Flow Technology AV Access Registry (STAAR) will be developed within the Vascular Quality Initiative® (VQI) using the M2S PATHWAYS clinical platform.
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. The STAAR project 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 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. Experienced Data and Project Management teams from M2S have been chosen by the SVS PSO to support this project. An SVS PSO appointed Steering Committee, chaired by Richard Neville, M.D., will oversee the project, analysis, and publication of results. Sites will be selected to participate in this quality improvement project based on their volume of Hemodialysis Access procedures and interest in collecting additional procedure and follow-up data. Participating sites will be reimbursed for the expense of entering additional data for this project which allows sites to offset the cost of
participating in VQI.
Greg Lange, President and CEO of M2S, adds, “By leveraging the Vascular Quality Initiative platform, M2S’ experience managing clinical projects and the SVSPSO’s clinical oversight, VFT can observe real world performance of their Spiral Flow Graft in an efficient and unbiased manner. M2S is eager to support VFT in this effort and advance our mission to improve healthcare quality.”
Dr. Barbara Bunger, Chief Clinical Officer for Vascular Flow Technologies, commented: “We anticipate the STAAR dataset to help confirm existing studies showing Spiral Flow™ grafts have higher patency rates, and require fewer interventions than PTFE grafts resulting in lower costs to healthcare payers and healthcare providers.”