Drug eluting peripheral balloon dilatation catheter

Recently, the State Food and Drug Administration in accordance with the "special innovative medical device approval process (Trial)", approved by the Beijing first medical technology limited production of “ drug eluting peripheral balloon dilatation catheter &rdquo listed.

This product for the whole exchange type balloon catheter, containing paclitaxel eluting surface for balloon percutaneous transluminal angioplasty of femoral artery and popliteal artery (PTA). In the process of balloon catheter dilatation, paclitaxel in the drug coating was released into the target vessel wall to inhibit neointimal hyperplasia. The results of clinical trials showed that the effect was better than that of uncoated balloon catheter. This product is the first domestic drug eluting balloon catheter for peripheral artery, which provides a new treatment option for clinicians and patients.

Food and drug supervision and management departments will strengthen the supervision after the listing of products to protect the safety of patients with machinery.