US-based materials science firm WL Gore & Associates has received Health Canada approval for its vascular stent GORE TIGRIS to treat patients with peripheral artery disease (PAD).
Developed to improve the natural movement of the knee during the treatment of PAD, GORE TIGRIS features a dual-component structure made of a single-wire nitinol stent with flexible and biocompatible fluoropolymer interconnections.
The design of the stent is expected to ensure that the biomechanical forces such as extension, compression, flexion and torsion, do not cause any fractures in anatomies such as the superficial femoral artery (SFA) and popliteal arteries.
The stent's US Food and Drug Administration (FDA) approval was based on a clinical study, which showed zero fractures at 12 months, while the control arm devices were found to have a 27% fracture rate.
Gore Peripheral Interventional business unit leader Ray Swinney said: "To design an uncovered stent that navigates and conforms to the complex anatomy of the artery, we leveraged our long history with endovascular devices to develop the GORE TIGRIS vascular stent.
"The addition of this device to our peripheral interventional portfolio enables physicians to treat more diverse cases with Gore’s best in class products.”
The new stent also features a heparin bonding technology called Gore's CBAS Heparin Surface for resistance against thrombus formation.
The heparin is anchored to the stent surface using the end-point covalent bonding and the bioactive site remains free to interact with the blood to aid clotting.
The GORE TIGRIS vascular stent has secured the CE mark approval in 2011.
Image: GORE TIGRIS vascular stent. Photo: courtesy of WL Gore & Associates.