Shanghai, China — Recently, the second-generation Transcatheter Aortic Valve Implantation (TAVI) products independently developed by MicroPort CardioFlow Medtech Corporation (02160.HK, “CardioFlow”)—the VitaFlow Liberty^® Transcatheter Aortic Valve and Retrievable Delivery System ("VitaFlow Liberty^®") and the Alwide^® Plus Balloon Catheter ("Alwide^® Plus")—have received approval for market launch from Ecuador’s National Agency for Health Regulation, Control, and Surveillance (ARCSA) (Licence No.: 18677-DME-0525/18634-DME-0525). With this milestone, Ecuador has become the sixth Latin American market successfully entered by CardioFlow, following Argentina, Colombia, Chile, Mexico, and Brazil. In recent years, the TAVI penetration rate in Ecuador has shown a continuous upward trend, with growing demand for medical devices, laying a solid foundation for accelerating product commercialization.

VitaFlow Liberty^® is the world’s first electrically retrievable TAVI product, approved for market launch by China’s National Medical Products Administration (NMPA) in 2021 (Registration Certificate No.: 国械注准20213030586). Since then, it has entered multiple overseas markets and, in 2024, became the first China-made TAVI system to receive EU CE MDR certification. Building on the strengths of the VitaFlow^® Transcatheter Aortic Valve and Delivery System in valve design, VitaFlow Liberty^® adopts a hybrid-density self-expanding stent, bovine pericardial leaflets, and a double-layer PET skirt, offering excellent features such as high radial support, improved coaxial deployment, and reduced risk of paravalvular leakage. Additionally, its breakthrough upgraded delivery system features a unique dual-wire helical structure, ensuring rapid, stable, and precise deployment and retrieval while achieving enhanced flexibility and 360° bending capability in the valve segment.

Alwide^® Plus, a companion product for TAVI procedures, received NMPA approval in 2021. As the company continues to expand globally, its registration for the EU CE MDR mark has also made significant progress. Alwide^® Plus incorporates an innovative design, with ultra-low compliance enabling more precise balloon dilation and minimizing vascular injury. Its high burst pressure performance effectively expands severely calcified areas, better addressing the high calcification characteristics of Chinese patients. The rapid inflation and deflation capabilities significantly reduce the impact of prolonged blood flow blockage on cardiac function, shortening pacing time and lowering surgical risks. Furthermore, its significantly improved puncture resistance enhances the user experience while further increasing the safety of intraoperative balloon dilation.

In recent years, CardioFlow has deepened its global strategy and accelerated the expansion of its international business. To date, its VitaFlow^® series of TAVI products and Alwide^® balloon series have entered over 700 leading hospitals in more than 20 countries and regions, treating over 10,000 patients with aortic valve disease worldwide. Moving forward, the company will continue to drive innovation and actively expand into international markets, further strengthening the influence of "Intelligent manufacturing in China" in the global structural heart disease treatment field and bringing hope to more patients.