FDA approves GORE TIGRIS vascular stent. -W. L. Gore & Associates.
W. L. Gore & Associates, better known as just Gore, won FDA approval for its GORE TIGRIS vascular stent. The device combines traditional nitinol metal with fluoropolymer interconnections. This gives it impressive strength and flexibility to resist the mechanical forces applied by either superficial femoral artery (SFA) or proximal popliteal artery (PPA), depending on the site of implantation.
In a study that led to the FDA approval, the GORE TIGRIS had no fractures at all while 27% of the control devices experienced fractures. The GORE TIGRIS also uses the firm�s CBAS Heparin Surface, a blood thinning component that helps prevent thrombi from forming around the stent. This technology bonds the heparin to the stent while keeping the other side free to react with thet:m blood passing by.
Comment: The GORE TIGRIS device, gained CE Mark approval in 2011.