CARDIOFLOW-B: Alwide® Plus cardiac valve balloon dilation catheter has obtained CE mark approval

Zhitong
2025.08.18 14:59
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CARDIOFLOW-B announced that its Alwide® Plus cardiac valve balloon dilation catheter has received CE mark approval, meeting European health, safety, and environmental standards. This product is used for pre-dilation of calcified aortic valves in transcatheter aortic valve implantation (TAVI), featuring ultra-low compliance, high burst pressure, rapid filling, and excellent puncture resistance, reducing surgical risks. This approval will facilitate the commercialization of products such as VitaFlow Liberty® in Europe, further advancing the company's overseas strategy

According to the Zhitong Finance APP, CARDIOFLOW-B (02160) announced that the Alwide® Plus heart valve balloon dilation catheter (Alwide® Plus) has received CE marking approval (a certification mark indicating that products sold within the European Economic Area meet health, safety, and environmental protection standards).

Alwide® Plus is a surgical accessory product independently developed by the company, used to dilate calcified aortic valves prior to transcatheter aortic valve implantation (TAVI), reducing the challenges of performing valvuloplasty during TAVI surgery. Its main features include: ultra-low compliance for more precise balloon dilation, avoiding vascular damage; high burst pressure performance to effectively open severely calcified areas, better addressing patients' high calcification characteristics; rapid filling/aspiration performance to minimize the impact of prolonged blood flow interruption on cardiac function, reducing pacing time and lowering surgical risks; and excellent puncture resistance to ensure the safety of balloon dilation during surgery, providing a better user experience for operators. After receiving approval from the National Medical Products Administration of China in August 2021, Alwide® Plus has successively obtained registration approvals from more than ten overseas countries or regions. The CE marking approval for Alwide® Plus will provide a more optimized treatment solution for TAVI surgeries in Europe, contributing to the group's overseas revenue growth, promoting the commercialization process of the VitaFlow Liberty® transcatheter aortic valve and its retrievable delivery system (VitaFlow Liberty®) in Europe, and accelerating the registration process of both products in other countries globally, further deepening the implementation of the group's overseas strategy.

Alwide® Plus is the fourth self-developed product to receive CE marking approval after VitaFlow Liberty®, AnchorMan® left atrial appendage occlusion system, and its guiding system, enriching the company's product matrix in the important market of structural heart disease in Europe. This once again demonstrates the group's leading technological reserves and R&D strength in the global structural heart disease medical device field, as well as the foresight of its global strategic layout. The synergistic effects among these four products can mutually promote their commercialization processes, further enhancing the company's comprehensive competitiveness in the international high-end medical device market

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