先瑞达医疗-B(06669):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
ACOTECACOTEC(HK:06669) 智通财经网·2025-11-18 10:02

Core Viewpoint - The company, Xianruida Medical-B (06669), has received registration approval from the National Medical Products Administration of China for its coronary overall exchange balloon dilation catheter, Jingyi®, which is designed to improve myocardial perfusion in patients with coronary artery stenosis [1] Group 1: Product Details - Jingyi® is suitable for balloon dilation at sites of coronary artery stenosis or bypass graft stenosis, with balloon diameters ranging from 2.0 to 5.0 mm also applicable for post-stent dilation [1] - The product features a semi-compliant balloon dilation catheter with a smaller head diameter and optimized delivery system, enhancing its passability and pushability [1] - Jingyi® effectively addresses complex lesions such as chronic total occlusions and severe calcifications, improving surgical efficiency and safety through its overall exchange design [1] Group 2: Market Strategy - The company plans to conduct marketing activities in China at an appropriate time following the approval [1]