Drug-eluting peripheral balloon dilatation catheter approved for marketing

June 06, 2016 Source: CFDA

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Recently, the State Food and Drug Administration approved the “drug-eluting peripheral balloon dilatation catheter” produced by Beijing Xianruida Medical Technology Co., Ltd. in accordance with the “Innovative Medical Device Special Approval Procedure (Trial)”.

The product is a unitary exchange balloon dilatation catheter with a paclitaxel drug coating on the surface of the balloon for percutaneous transluminal angioplasty (PTA) of the femoral artery and radial artery. During balloon catheter dilation, paclitaxel in the drug coating is released into the target vessel wall, inhibiting neointimal hyperplasia. Clinical trial results have shown that their effectiveness is superior to uncoated balloon dilatation catheters. This product is China's first domestic drug-eluting balloon dilatation catheter for peripheral arteries, providing new treatment options for clinicians and patients.

The food and drug supervision and administration department will strengthen the supervision of products after listing and protect the safety of patients.

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