Core Viewpoint - The company has received CE mark approval for its Alwide Plus balloon dilation catheter, enhancing its product offerings in the transcatheter aortic valve implantation (TAVI) market in Europe [1][2]. Group 1: Product Features and Benefits - Alwide Plus is designed to expand calcified aortic valves prior to TAVI, reducing the challenges associated with valve shaping during the procedure [2]. - Key features include ultra-low compliance for precise balloon expansion, high burst pressure for effectively opening severely calcified areas, rapid filling and deflation to minimize blood flow interruption, and excellent puncture resistance for enhanced safety during the procedure [2]. Group 2: Market Impact and Strategic Importance - The CE mark approval will optimize treatment options for TAVI in Europe, contributing to increased overseas revenue for the company [2]. - Alwide Plus is the fourth self-developed product to receive CE mark approval, enriching the company's product matrix in the structural heart disease market in Europe [3]. - The approval demonstrates the company's leading technological reserves and R&D capabilities in the global structural heart disease medical device sector, enhancing its competitive edge in the international high-end medical device market [3].

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]