Core Viewpoint - The company, Xianruida Medical-B (06669.HK), has received 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 Approval - The approval was granted on November 13, 2025, for the Jingyi® balloon dilation catheter [1] - The product is suitable for balloon dilation at sites of coronary artery stenosis or bypass graft stenosis [1] - The catheter features a diameter range of 2.0-5.0mm, which is also applicable for post-stent dilation [1] Group 2: Product Features - Jingyi® is a semi-compliant balloon dilation catheter that offers superior passability and pushability due to its smaller head diameter and optimized delivery system [1] - The design effectively addresses complex lesions such as chronic total occlusions and severe calcifications [1] - The overall exchange design enhances surgical efficiency and safety [1] Group 3: Marketing Plans - The company plans to initiate marketing activities in China at an appropriate time following the approval [1]
先瑞达医疗-B(06669.HK)：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