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冠脉整体交换型球囊扩张导管井翼
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先瑞达医疗-B:冠脉整体交换型球囊扩张导管井翼 的注册申请获中国国家药品监督管理局批准
Zhi Tong Cai Jing· 2025-11-18 10:06
Core Viewpoint - The company received approval from the National Medical Products Administration of China for its coronary overall exchange balloon dilation catheter, enhancing its product portfolio in the cardiovascular medical device market [1] Product Approval - The approval is for the "井翼" balloon dilation catheter, which is designed for treating coronary artery stenosis and bypass graft stenosis [1] - The catheter features a diameter range of 2.0-5.0mm, suitable for post-stent dilation [1] Product Features - The "井翼" is a semi-compliant balloon dilation catheter that offers superior passability and pushability due to its smaller head diameter and optimized delivery system [1] - It effectively addresses complex lesions such as chronic total occlusions and severe calcifications, improving procedural efficiency and safety [1] Marketing Plans - The company plans to initiate marketing activities in China at an appropriate time following the approval [1]