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Spiral Flow™ AV graft shows substantial improvement in patency over current standard of care

08:20 EDT 16 Apr 2015 | Instinctif Partners

Independent study shows primary patency of 72% at 18 months, compared to 36.7% for PTFE graft

Dundee, UK, 16 April, 2014Vascular Flow Technologies (VFT), the medical device company using proprietary Spiral Laminar Flow™ (SLF™) technology to replicate natural blood flow for enhanced patient outcomes, announce today the presentation of independent study results demonstrating substantially better primary patency rates for its Spiral Flow™ arteriovenous (AV) graft than for polytetrafluoroethylene (PTFE) graft.

The SLF graft for haemodialysis: midterm results of the first European series, was presented at the Vascular Access Society meeting in Barcelona, Spain, and showed 18-month primary patency rates of 72% for Spiral Flow™ AV graft, compared to 36.7% for PTFE grafts, which are the current standard of care. 

Investigator Dr Wolfgang Hofmann, of the Department of Vascular Surgery, Feldkirch General Hospital, Austria, who presented his data and analysis commented:  “The results are more than satisfactory, particularly as the patients receiving Spiral Flow™ grafts were negatively selected.”

The study compared 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 were only used if, according to pre-operative duplex mapping, patients were not suitable for any type of autologous fistula.

Follow-up consisted of duplex mapping every 3 months, and additional duplex scanning if there was suspicion of impending shunt failure.   Of the 15 patients receiving Spiral Flow™ AV grafts, there were four shunt occlusions, of which two were managed by thrombectomy.  Primary patency at 18 months for Spiral Flow™ AV grafts, calculated by Kaplan Meier, was 72%, secondary patency was 85.5%. 
The study results provide strong support for the premise of VFT’s Spiral Flow™ technology.   Spiral Flow™ grafts are designed to encourage a spiral laminar flow within the graft, which replicates the natural flow in blood vessels.  This reduces turbulence at the distal (venous) end of the graft, so reducing shear stress, endothelial activation and platelet activation that precede thrombus formation at the distal anastomosis.  The study used duplex mapping to confirm the presence of spiral flow in the grafts. 

Dr Hofmann commented:  “We have long known that prosthetic graft failure is a normal tissue response to an abnormal flow environment.  It was particularly gratifying to see that changing the flow pattern at the venous anastomosis improves the patency of the graft.”

About Vascular Flow Technologies

Vascular Flow Technologies (VFT) is a leading innovator focused on the research, development and commercialisation of devices to improve blood flow in compromised or diseased blood vessels utilising its proprietary Spiral Laminar Flow™ (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 commercialised 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 the study

The SLF graft for hemodialysis - midterm results of the first European series, by Wolfgang J Hofmann, Feldkirch General Hospital, Department of Vascular Surgery, Feldkirch, Austria, was presented at the Vascular Access Society meeting in Barcelona, Spain, 15-18 April 2015.  

For information about the Vascular Access Society meeting, see: www.vas2015.org

For a copy of the poster, contact Vascular Flow Technologies via: info@vascular-flow.com

For more information, please contact: Bill Allan CEO, Vascular Flow Technologies Telephone: +44 (0) 1382 598 532 Email: info@vascular-flow.com For media enquiries, please contact: Dr Lynne Trowbridge / Ruth Ashton Instinctif Partners Telephone: +44 207 866 7936 Email: VFT@instinctif.com NEXT ARTICLE

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