Recently, the State Drug Administration approved the registration application of the innovative product "anchored balloon dilation catheter" produced by Hunan eput medical device Co., Ltd. This product is the first innovative medical device for catheter exchange in the guide tube by balloon anchoring in China, which is used for interventional treatment of coronary artery stenosis caused by coronary atherosclerosis and other diseases.

  in the past, the withdrawal of microcatheter in percutaneous coronary angioplasty generally adopted pressure pump recoil technology and extended guide wire technology, but it may be difficult to operate, guide wire displacement or even exit from the lesion. The approved anchored balloon expansion catheter uses balloon anchoring to fix the guide wire of the guide tube, making the guide wire retraction more convenient.

   the anchor balloon expansion catheter adopts the design of single cavity delivery pipe without guide wire channel. The balloon is directly connected to the catheter body, and the anchor balloon expansion catheter does not rely on guide wire delivery. At the same time, the product adopts stainless steel conduit, and there is a spiral transition structure at the far end of the tube body, which is expected to show good push performance and reduce the risk of damaging the guide conduit during push. In addition, due to the structural design of the product to achieve a smaller through outer diameter, it is expected to improve the compatibility with a variety of listed guide catheters and microcatheters. Compared with the current clinical operation mode, the product is expected to reduce vascular complications, shorten operation time and improve operation success rate.

  the drug regulatory department will continue to be guided by clinical needs and speed up the approval of clinical urgently needed medical devices. At the same time, strengthen the post marketing supervision of listed products to protect the safety of patients.