China, Shanghai – Recently, the second-generation TAVI product VitaFlow Liberty^® Transcatheter Aortic Valve and Retrievable Delivery System (“VitaFlow Liberty^®”), independently developed by MicroPort CardioFlow Medtech Corporation (02160.HK, “CardioFlow”), has received market approval (Licence No.: 81667100074) from the Brazilian National Health Surveillance Agency (ANVISA). The Alwide^® Plus Balloon Catheter, designed for use with this product, had previously obtained market access in Brazil.

VitaFlow Liberty^® is the world’s first electric retrievable TAVI product, approved for market launch in 2021 by China’s National Medical Products Administration (NMPA) (Registration Certificate No.: Guo Xie Zhun 20213030586). Since then, it has entered multiple overseas markets and, in 2024, became the first “Made-in-China” TAVI system to receive EU CE MDR certification. Building on the strengths of the VitaFlow^® Transcatheter Aortic Valve and Delivery System, it features a hybrid-density self-expanding stent, bovine pericardial leaflets, and a double-layer PET skirt design, delivering high radial strength, enhanced coaxial deployment, and reduced paravalvular leakage. Additionally, its breakthrough upgraded delivery system incorporates an innovative dual-helix structure, ensuring rapid, stable, and precise deployment/retrieval while enabling 360° bending flexibility for improved trackability.

Leveraging outstanding product innovation and strong clinical validation, CardioFlow has made steady progress in its global expansion strategy, with its market presence continuously growing. To date, its VitaFlow^® TAVI series and Alwide^® balloon accessory products have entered over 700 leading hospitals across over 20 countries and regions, treating more than 10,000 aortic valve disease patients worldwide.

As a core BRICS member, Brazil is not only the largest economy in Latin America (ranking among the top globally) but also the most populous country in the region, boasting a vast healthcare market. In the field of structural heart disease treatment, Brazil’s TAVI market is experiencing rapid growth, with an estimated 3,500–4,000 procedures projected for 2025. The approval of VitaFlow Liberty^® in Brazil marks a major breakthrough for China’s high-end medical devices in Latin America, challenging the duopoly of two U.S. giants that currently dominate approximately 90% of the market share. Moreover, it serves as a strategic foothold for CardioFlow to tap into high-potential overseas markets, providing strong momentum for its accelerated global strategy.