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  • Drug-eluting balloon catheter approved
    Jan 12, 2018

    Recently, the State Food and Drug Administration has reviewed and approved the registration of Drug Eluting Balloon Catheter applied by Liaoning Eiyi Biological Technology Co., Ltd.

    The product is an Rx-based balloon dilatation catheter coated with a drug coating on the surface of the balloon, which is suitable for dilatation of stenosis of primary coronary bifurcation lesions.

    This product is the first drug-eluting balloon catheter in the world approved for bifurcation of coronary artery disease and provides a new therapeutic strategy for the treatment of bifurcation lesions that are urgently needed in clinic.

    Food and Drug Administration will strengthen supervision of the product after the market, to protect patients with mechanical safety.