Core Insights - The company HeartLink Medical-B (02160.HK) announced that its AlwidePlus cardiac balloon dilation catheter has received CE marking approval, indicating compliance with health, safety, and environmental standards for products sold in the European Economic Area [1][2] Group 1: Product Features - AlwidePlus is a self-developed surgical accessory designed to dilate calcified aortic valves prior to transcatheter aortic valve implantation (TAVI), reducing the challenges associated with valve shaping during the procedure [1] - Key features of AlwidePlus include: - Ultra-low compliance for precise balloon expansion, minimizing vascular damage [1] - High burst pressure performance to effectively expand severely calcified areas, addressing the high calcification characteristics of patients [1] - Rapid filling and deflation capabilities to minimize prolonged blood flow interruption, reducing pacing time and surgical risks [1] - Excellent puncture resistance to ensure safety during balloon expansion, enhancing the user experience for operators [1] Group 2: Market Impact - The CE marking approval for AlwidePlus will provide an optimized treatment option for TAVI procedures in Europe, contributing to incremental overseas revenue for the company [2] - This approval will facilitate the commercialization of the VitaFlow Liberty transcatheter aortic valve and its retrievable delivery system in Europe, while also accelerating the registration process in other global markets [2] - The developments align with the company's strategy to deepen its overseas market presence [2]
心通医疗-B(02160.HK)：Alwide®Plus心脏瓣膜球囊扩张导管CE标志批准