Recently, the State Drug Administration approved the registration of the innovative product "balloon dilated intravascular covered stent system" produced by W.L. Gore & Associates, Inc.

   the product is composed of intravascular covered stent and delivery system, in which the intravascular covered stent is pre installed on PTA balloon. The intravascular covered stent consists of 316L stainless steel ring and membrane. It is used to treat primary occlusive lesions of common iliac artery and external iliac artery, including primary occlusive lesions at the bifurcation of main iliac artery.

   the metal part of the support adopts an independent stainless steel ring structure, which is connected to each other through the coating, and it is expected to obtain high radial support force and flexibility. The design of balloon expansion stent is helpful to provide better radial support, improve the adjustability of diameter and the accuracy of placement. The product provides a new treatment option for patients with primary occlusive lesions of common iliac artery and external iliac artery.

     the drug regulatory department will strengthen the post marketing supervision of the product to protect the safety of patients.