|
Overview
Cardiovascular disease is the leading cause of death in westernized countries According to the American Heart Association, almost 60 million Americans have one or more types of cardiovascular disease and despite recent advances in cardiovascular therapies, it still results in more than one million deaths per year.
TFT's research has shown that products with Spiral Laminar Flow™ design, by mimicking naturally occurring three-dimensional blood flow patterns can minimise vascular occlusion following surgical intervention.
Technology
The key clinical observation is of naturally occurring Spiral Laminar Flow™ in healthy human arterial systems: A mathematically based modeling procedure, computational fluid dynamics (CFD), demonstrated that a Spiral Laminar Flow™ pattern produces reductions in turbulence and in near wall kinetic energy of several orders of magnitude. The pathological process of blockage at graft-vessel anastomoses and within vascular stents, called neo-intimal hyperplasia (NIH) is driven to a large part by this kinetic disturbance. Grafts and stents delivering less turbulent energy by utilizing Spiral Laminar Flow™ will produce less NIH, thus prolonging the effective life of the devices.
Clinical research using MRI and Ultrasound has shown that spiral flow is prevalent in normal subjects and that this prevalence is reduced in patients with arterial disease. Furthermore the reduction in prevalence of spiral flow in arteries is more pronounced in more severe disease and is associated with more rapid progression of disease. Since atherosclerotic vessels have lost this flow pattern, it is thought that restoring the pattern would normalise blood flow and protect the downstream vessels from further disease progression. Devices that achieve this should therefore be more advantageous than the standard design. Both synthetic and biologic grafts have a tendency to block at the distal anastomosis to the downstream vessel, a site of maximum turbulence. It is the reaction in the native vessel wall at the anastomosis that causes the secondary stenosis and ultimately the failure of the graft. By producing a graft design that induces spiral laminar flow™, TFT will reduce the turbulence at this critical area, which is predicted to significantly extend graft life with commensurate clinical and economic benefits.
|
