CardioFlow Medtech Receives Approval for Alwide® Plus Balloon Catheter in Argentina

Shanghai, China - MicroPort CardioFlow Medtech Corporation ( MicroPort CardioFlow) recently announced that the their Alwide® Plus Balloon Catheter (Alwide® Plus) has received marketing approval from the Argentine National Administration of Drugs, Foods, and Medical Devices (ANMAT).

Alwide® Plus is the second-generation product of the Alwide® balloon catheter, and received its registration approval from the National Medical Products Administration of China in July 2021. Designed to provide precise inflation sizing, its high burst pressure responds better to the severe calcification that is commonly found among patients in China. In addition, Alwide® Plus minimizes pacing time, thanks to its faster inflation and deflation speed. Alwide® Plus has significantly improved burst pressure and sheath design at the distal end of the catheter, resulting in a better user experience and increased safety of intraoperative balloon dilation[1].

CardioFlow Medtech has had several products enter the Argentinian market prior to the approval of Alwide® Plus. The VitaFlow® Transcatheter Aortic Valve and Delivery System (VitaFlow®) had its first overseas implantation at Dr. Julio Mendez Hospital, Argentina in August 2021, and has since been successfully used in TAVI procedures in several hospitals in Argentina, establishing a solid foundation for VitaFlow Liberty™ to serve the Argentine market. VitaFlow Liberty™ Transcatheter Aortic Valve and Retrievable Delivery System (VitaFlow Liberty™) also received marketing approval by ANMAT in December 2021.

The successful launch of Alwide® Plus in Argentina marks another strong step forward for CardioFlow Medtech’s product line, enabling them to support local TAVI surgeons in handling different surgical challenges. Looking ahead, CardioFlow Medtech will continue to accelerate the commercialization of innovative products and introduce TAVI products to more countries and regions, bringing high-quality, universal total solutions for structural heart disease to more patients around the world.

[1] Clinical Results from CardioFlow Medtech (compared with the Alwide® balloon catheter)