Vascular Flow Technologies collaborates with Society for Vascular Surgery® Patient Safety Organization and M2S® for a new post-market observational registry

FOR IMMEDIATE RELEASE

Chicago, IL, West Lebanon, NH and Dundee, UK – 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.”

Notes to Editors

About Vascular Flow Technologies

Vascular Flow Technologies is a leading innovator focused on the research, development and commercialization of devices to improve blood flow in compromised or diseased blood vessels utilizing its proprietary Spiral Laminar FlowTM (SLF™) technology. Natural blood flow has a distinctive singular spiral flow pattern and the patented SLF™ technology is the only clinically-proven design to replicate this.

VFT has two CE marked and FDA approved devices commercialized in Europe and the US, the Spiral Flow™ peripheral bypass (PV) graft and the Spiral Flow™ arteriovenous access (AV) graft. The SLF™ technology is used to create a longer lasting graft or stent, producing a better quality of life for the patient due to reduced vascular complications and improved longevity of the implant. VFT is a privately held company with headquarters in Dundee, UK.

Further information is available at www.vascular-flow.com

ABOUT M2S, INC.

M2S, Inc., the exclusive technology provider of the Vascular Quality Initiative® (VQI®), is a healthcare performance management solutions company that provides innovative technology and services for the healthcare industry to manage clinical information and utilize that information to improve the quality of patient care and reduce costs. The VQI® is built on the M2S PATHWAYS clinical data performance platform, which allows users to track, measure, and analyze clinical information, promote collaboration, objectively drive decisions, and optimize performance. For more
information, visit www.m2s.com.

ABOUT THE SOCIETY FOR VASCULAR SURGERY PATIENT SAFETY ORGANIZATION

The Society for the Vascular Surgery Patient Safety Organization (SVS PSO) strives to improve patient safety and the quality of vascular health care delivery by providing web-based collection, aggregation, and analysis of clinical data submitted in registry format for patients undergoing specific vascular treatments through the use of the M2S PATHWAYS cloud-based data platform. The SVS PSO provides outcome analysis intended to be an integral component of each participating health care provider’s quality improvement efforts, including the implementation of
recommendations, protocols, and best practices by the SVS PSO. (www.svsvqi.org)

For media enquiries, please contact:

Dr. Lynne Trowbridge / Ruth Ashton
Instinctif Partners
Telephone: +44 207 866 7936
Email: VFT@instinctif.com

Nancy Heatley
M2S, Inc.
Telephone: +1 603 298 5509 x364
Email: nheatley@m2s.com

Kay Severinsen
Society for Vascular Surgery
Telephone: +1 312 XXX 2317
Email: kseverinsen@vascularsociety.org