Core Viewpoint - Xianruida Medical-B (06669) has received approval from the National Medical Products Administration of China for its microcatheter V-otter, which is designed for use in peripheral and coronary vascular interventional procedures, leading to a stock price increase of over 5% during trading [1]. Company Summary - Xianruida Medical-B's stock price rose by 3.25% to HKD 13.01, with a trading volume of HKD 2.4495 million [1]. - The V-otter microcatheter is specifically designed for transcatheter arterial chemoembolization (TACE) procedures, featuring a large lumen design to effectively prevent catheter blockage during operations [1]. - The product offers three types of tip configurations: straight, 45° single bend, and multiple bends, allowing for adaptability to various clinical needs and precise access to target blood vessels [1].

先瑞达医疗-B(06669)发布公告，于2025年12月1日，集团收到中国国家药品监督管理局对微导管V-otter 的注册批准。V-otter适用于外周和冠脉血管经皮介入手术中，到达预期血管部位后输注诊断性、栓塞性 或治疗性的材料。V-otter是一款应用在肝动脉化疗栓塞术(TACE)中的微导管，其采用大内腔设计，可有 效避免术中导管堵塞;产品提供直型、45°单弯及多弯曲三种头端塑形选择，可根据临床实际需求从容适 配不同角度的分支血管，从而实现精准、稳定地抵达靶血管，为后续操作做好准备。公司将适时在中国 开展营销活动。 ...

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]