Spiral Laminar Flow grafts show encouraging midterm patency results
Advantages of spiral flow laminar flow stability
–Spiral flow preserves laminar flow through a stenosis better reducing turbulent kinetic energy
Why a spiral flow graft?
- Intimal hyperplasia at the distal anastomosis is a frequent reason for graft failure.
- Development of intimal hyperplasia is a reaction of the blood vessel to abnormal flow patterns
- By inducing normal, spiral flow the development of intimal hyperplasia can be prevented
Patients and Methods
Phase 1 Study using 6 mm ringed ePTFE SLF graft (Vascular Flow Technologies Ltd). Spiral inducer at distal end to induce spiral flow at distal anastomosis.
39 Patients from 8 centres in Benelux
Study inclusion 02/06- 10/07; 5 year follow-up till 07/2013
- 73 % male, 27% female
- 59% above knee, 41% below knee
- 57% CLI, 43% Claudication
- 13% diabetics
- 43% current smokers
In 10 random patients the presence of spiral laminar flow at 3-6 months was assessed. All showed the distinctive flow pattern.
The five year cumulative patency rates were 62% above knee and 52% below knee.
- The phase 1 study showed that implantation of the Spiral Flow graft is feasible and safe.
- The Spiral Flow graft induces Spiral Laminar Flow at the distal anastomosis
- The 5 year results are encouraging compared to published literature
- Other products incorporating Spiral Laminar Flow technology are in development