Shanghai, China — MicroPort CardioFlow MedTech Corporation (CardioFlow, 02160.HK) recently announced that its self-developed second-generation balloon catheter, the Alwide^® Plus Balloon Catheter (Alwide^® Plus), has successfully obtained EU CE Mark certification (Certificate No.: 6126688CE01, 6126688TD02). This milestone makes Alwide^® Plus the company's fourth independently developed product approved for the European market, following the VitaFlow Liberty^® Transcatheter Aortic Valve and Retrievable Delivery System (VitaFlow Liberty^®) and the AnchorMan^® Left Atrial Appendage Closure System along with its access system.

As a critical supporting device for TAVI (Transcatheter Aortic Valve Implantation), Alwide^® Plus received marketing approval from China's National Medical Products Administration (NMPA) in July 2021 (Registration No.: 20213030586) and has since been introduced in over ten countries and regions, including Argentina, Colombia, Brazil, Thailand, Russia, Indonesia, Saudi Arabia, Hong Kong (China), Mexico, Kazakhstan, Belarus, and Ecuador.

Since its launch, Alwide^® Plus has gained widespread recognition among physicians in more than 700 leading hospitals worldwide due to its outstanding clinical performance. Its ultra-low compliance enables precise balloon dilation, minimizing vascular injury, while its high burst pressure capability effectively dilates severely calcified areas, addressing patients' challenging calcification profiles. The catheter's rapid inflation and deflation properties significantly reduce prolonged blood flow obstruction, shortening pacing time and lowering procedural risks. Additionally, its enhanced puncture resistance improves both user experience and intraoperative safety during balloon dilation.

The CE Mark approval of Alwide^® Plus will not only provide European TAVI procedures with optimized treatment options and contribute to the company's overseas revenue growth but also accelerate the commercialization of VitaFlow Liberty^® in Europe while expediting the regulatory processes for both products in other global markets. This achievement further advances CardioFlow's internationalization strategy and underscores its leading technological capabilities, R&D strength, and forward-thinking approach in the global structural heart disease medical device sector.

Moving forward, CardioFlow's four CE-certified products will synergistically enhance one another's commercialization, strengthening the company's competitive edge in the high-end global medical device market and delivering superior medical solutions to patients with structural heart disease worldwide.