CARDIOFLOW-B (02160) announced that its Alwide® Plus cardiac valve balloon dilatation catheter (Alwide® Plus) has received CE mark approval, which indicates that products sold within the European Economic Area comply with health, safety and environmental standards certification.

Alwide® Plus is a self-developed surgical accessory product designed to dilate calcified aortic valves prior to transcatheter aortic valve implantation (TAVI) procedures, reducing the challenges of performing valvuloplasty during TAVI surgery. Its main features include: ultra-low compliance enabling more precise balloon dilatation while avoiding vascular injury; high burst pressure performance that can effectively expand severely calcified areas, better addressing patients' high calcification characteristics; rapid inflation/deflation performance that minimizes the impact of prolonged blood flow interruption on cardiac function, reducing pacing time and lowering surgical risks; and excellent puncture resistance performance that ensures the safety of intraoperative balloon dilatation, providing surgeons with a better user experience.

After receiving approval from China's National Medical Products Administration in August 2021, Alwide® Plus has successively obtained registration approvals in more than ten overseas countries or regions. The CE mark approval for Alwide® Plus will provide more optimized treatment solutions for European TAVI procedures. This will not only contribute incremental overseas revenue to the group, but also promote the commercialization process of VitaFlow Liberty® transcatheter aortic valve and retrievable delivery system (VitaFlow Liberty®) in Europe, and accelerate the registration process of both products in other global countries, further deepening the implementation of the group's overseas strategy.

Alwide® Plus is the fourth self-developed product to receive CE mark approval following VitaFlow Liberty®, AnchorMan® left atrial appendage occlusion system and its guidance system, enriching the company's product portfolio in Europe, an important market in the structural heart disease field. This again demonstrates the group's leading technological reserves and R&D capabilities in the global structural heart disease medical device field, as well as the forward-looking nature of its globalization strategic layout. Through the synergistic effects among the four products, they can mutually promote each other's commercialization process and further enhance the company's comprehensive competitiveness in the international high-end medical device market.