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Data presented at VEITH Symposium show 30% increase in one-year success rates for vascular bypass surgery, and dramatic reduction in amputations

Vascular Flow Technologies have presented study results at the 41st Annual on Vascular and Endovascular Issues in New York, showing a 30% increase in one-year success for infrainguinal vascular bypass surgery in patients who received a ™ Graft compared to those who received a standard polytetrafluoroethylene (PTFE) graft.

The study shows one-year primary and secondary patency rates of 76% and 87% for Spiral Flow™ Grafts (n=54), compared to 48% and 55% for PTFE bridge graft (n=124), as well as a dramatically lower amputation rate in patients receiving Spiral Flow™ Grafts (2% vs 10%).

The study was led by Mr Nick Shaper FRCS, Consultant Vascular Surgeon at Bradford Royal Infirmary, UK. Mr Shaper said: “All patients demonstrated post-operative spiral laminar flow at the distal anastomosis, and there was a substantial and highly encouraging improvement in one year patency rates in this group of patients.”

Spiral Laminar Flow™ (SLF™) technology is the only vascular graft technology that is proven to replicate natural blood flow by generating a spiral laminar flow within the graft, reducing turbulence at the point where the blood flows into the blood vessel,[1,2] which limits changes to the blood vessel wall that may be precursors to thrombosis.[3] These findings add to the growing body of evidence demonstrating improved clinical outcomes for patients who receive a Spiral Flow™ Graft.

The VEITH Symposium will also hear from Professor Richard Neville, Chief of the Division of Vascular Surgery, George Washington University Hospital. Professor Neville will present an update on the newly opened US registry for Spiral Flow™ arteriovenous (AV) grafts in haemodialysis access. The Spiral Flow™ AV Access Graft Clinical Registry will collect the primary, primary assisted and secondary patency rates of the Spiral Flow™ AV Access Graft in patients with End Stage Renal Disease (ESRD) as well as recording complication rates.

The registry will provide data to its physician users detailing their patients’ graft performance data compared to national performance. The registry will hold demographic, operative and postoperative graft performance data, and results. Findings will be presented at local, regional and national vascular conferences in the months ahead.

Bill Allan, CEO of Vascular Flow Technologies commented: “Clinical experience with Spiral Flow™ Grafts is continuing to grow, and the newly opened US registry will provide a further bank of data for evaluation of long-term patency and complication rates. We are encouraging haemodialysis physicians to view the portal and to seek Institutional Review Board (IRB) approval to start entering patient data.”

The Vascular Flow Clinical Registry portal can be accessed at www.vascular-flow-clinical-registry.com.

The study, Spiral Flow Prosthetic Grafts in Lower Extremity Bypasses – one year and beyond, compared prospective data on primary and secondary patency rates, interventions and complications at one year post-operation in 54 patients undergoing infrainguinal bypass using SLF grafts between 2011 and 2014, with retrospective data on all infrainguinal grafts (n=124) conducted using a conventional bridge graft between 2003 and 2008.

Source

1. Stonebridge PA, Buckley C, Thompson A, Dick J, Hunter G, Chudek JA, Houston JG, Belch JJ. Non spiral and spiral (helical) flow patterns in stenosis. In vitro observations using spin and gradient echo magnetic resonance imaging (MRI) and computational fluid dynamic modelling. In Angiol 2004 Sep;23(3):276-83.

2. Kokkalis E, Hoskins P, Corner G, Stonebridge P, Doull A, Houston G. Secondary flow in peripheral vascular prosthetic grafts using vector Doppler imaging. Ultrasound in Med & Biol 2013;39(12):2295-2307.

3. El Sayed HF. Vascular Flow Technology: Another run of the mill graft or a breakthrough technology? US experience and perspective. Presented at the 8th International St George’s Vascular Access Meeting at the 35th Charing Cross international vascular and endovascular symposium, 7th April 2013, London.

Source: Vascular Flow Technologies