Shanghai, China - MicroPort® CardioFlow Medtech Corporation (hereinafter referred to MicroPort® CardioFlow ,02160.HK) announced that its self-developed Alwide® Plus balloon catheter (hereinafter referred to as "Alwide® Plus") has been approved by the Argentine National Administration of Drugs, Foods, and Medical Devices (ANMAT).
Alwide® Plus, an upgrade of the Alwide® balloon catheter, received marketing approval from the China National Medical Products Administration (NMPA) on July 29, 2021. Its ultra-low compliance can realize more precise balloon expansion to avoid vascular damage; high burst pressure performance can effectively expand the site of severe calcification, which can better cope with the characteristics of Chinese patients with high calcification; fast filling and pumping performance can minimize the pacing time. In order to provide the surgeon with a better experience and increase the safety of intraoperative balloon expansion, Alwide® Plus has significantly improved puncture resistance.
Previously, several products from MicroPort® CardioFlow have entered the Argentine market. In August 2021, VitaFlow® Transcatheter Aortic Valve System completed its first overseas commercial implantation at Dr. Julio Mendez Hospital in Argentina, and has successfully performed TAVI procedures in several hospitals in Argentina on an ongoing basis. In December 2021, VitaFlow Liberty® Transcatheter Aaortic Valve and Retrievable Delivery System received marketing approval from ANMAT.
As an important part of the overall TAVI solution of MicroPort® CardioFlow, Alwide® Plus has further enriched the total valve solution product line of MicroPort® CardioFlow in the local area after being approved for listing in Argentina, which can help local TAVI physicians to cope with more different types of surgical challenges. In the future, MicroPort® CardioFlow will actively promote innovative research and development while deepening the Latin American market, and provide high-quality, universal medical solutions for structural heart disease for more patients around the world.
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