[Directly to the leading area] Good news! Many medical devices in Zhangjiang have been approved overseas

Zhangjiang’s innovative achievements not only benefit domestic patients, but also actively expand overseas markets and go global. Recently, Zhangjiang companies Ease Medical and Xinmai Medical™ have successively received good news that blockbuster medical devices have been approved overseas. Zhangjiang medical device products have been affirmed by more and more doctors and patients around the world.

Easy Medical’s third-generation stapler has recently been approved in Canada as its self-developed third-generation stapler—easyEndo® Lite disposable endoscopic cutting The stapler and its components have obtained the Medical Device License (MDL) issued by Health Canada (Health Canada). Important certification is expected to further enhance the company’s global brand influence.

The reporter learned that the easyEndo® Lite third-generation laparoscopic stapler is mainly used for the cutting and severing of lung, stomach, intestine and other tissues in various thoracoscopic laparoscopic operations and match. Compared with the traditional manual suture, the use of titanium nails to cut off or anastomose the tissue, the suture is tighter, faster and easier to operate, which can greatly shorten the operation time and improve the safety of the operation. According to incomplete statistics, Yisi Medical has successively obtained more than 100 international registration certificates, and its products have entered more than 50 countries and regions around the world.

The Reewarm® PTX drug balloon dilatation catheter independently developed by Xinmai Medical™ has recently been approved by the Brazilian Health Authority (ANVISA), which is a further step for the product to enter the global market lay the foundation. This product is suitable for balloon dilation of the femoral popliteal artery during percutaneous transluminal angioplasty. Paclitaxel acts on the diseased vessel wall to inhibit the proliferation of smooth muscle cells, thereby treating atherosclerotic stenosis or occlusive lesions.

Cardiovascular™ has 13 products on the market. Products have entered more than 1,300 hospitals across the country and exported to Europe, Latin America, Southeast Asia and other countries and regions.

By the end of 2021, 17 Class 1 new drugs and 15 innovative medical device products developed and declared by Zhangjiang have been approved for marketing, creating many national or global “firsts” ‘s record.

Text: Yang Zhenying

Editor: Wang Yumeng* For reprint, please indicate the official WeChat account from Pudong

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