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Drug balloon dilatation catheter products approved for marketing in China

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Author : Joe Wong
Update time : 2020-08-04 15:19:24
Drug balloon dilatation catheter products approved for marketing in China

Recently, the State Drug Administration approved the registration of the innovative product "Drug Balloon Dilatation Catheter" produced by ZHONGSHAN 2 MEDS TECHNOLOGY CO., LTD after review.

The product is an OTW balloon dilatation catheter, which is composed of a balloon, a developing ring, an inner tube, an outer tube, a stress diffusion tube and a Y-shaped connector. It is used for balloon dilation of femoral popliteal artery (except inferior knee artery) in percutaneous transluminal angioplasty to treat atherosclerotic stenosis or occlusive disease.

In clinical applications, this product expands the femoral popliteal artery (except the inferior knee artery), and the drug coating fully adheres to the inner wall of the diseased blood vessel, so that the drug can be effectively released, thereby inhibiting the re-stenosis of the diseased vessel and achieving the purpose of treatment. At the same time, no implants remain in the body for a long time, providing a new choice for clinical use.

CHINESE FOOD AND DRUAG ADMINISTRATIOIN will strengthen the post-market supervision of the product to protect the safety of patients' equipment.