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 inflation/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 and facilitating the commercialization of its VitaFlow Liberty® transcatheter aortic valve and delivery system in Europe [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 and demonstrating its technological capabilities and strategic foresight in global market expansion [3].

Core Viewpoint - The company has received CE mark approval for its Alwide® Plus cardiac 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 inflation/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 and facilitating the commercialization of its VitaFlow Liberty® transcatheter aortic valve and delivery system in Europe [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 and demonstrating its technological and research capabilities [3]. - The synergy among the four CE-marked products is expected to promote their respective commercialization processes, enhancing the company's competitiveness in the international high-end medical device market [3].