Shanghai, China – July 27, 2020 - Shanghai MicroPort® CardioFlow Medtech Co., Ltd. (“MicroPort® CardioFlow”) is pleased to announce it has received regulatory approvals for its VitaFlow® Aortic Valve System (“VitaFlow® System”), Alwide™ Balloon Catheter, and Alpass™ Introducer Set from ANMAT of Argentina. The VitaFlow® Aortic Valve System with a self-expanding frame with bovine pericardial leaflets, is the first of its kind to be approved in China. This also marked the first time a product developed by MicroPort® CardioFlow, receives approval in a market outside of China.
The VitaFlow® System is composed of transcatheter aortic valve and delivery system. The aortic valve features innovative double layer skirts that are designed to reduce the occurrence of paravalvular leaks. The hybrid density cells and nitinol frame enables the valve to effectively expand the calcified leaflets, while conforms and adapts to the annulus to provide consistent, outward radial force, offering surgeons stability and control during valve development. The large cells enable coronary access, ensuring that the patients are able to receive percutaneous coronary intervention (PCI) treatment in the future.
VitaFlow® also uses motorized delivery system to facilitate the accurate manipulation of guidewire by a single surgeon and the delivery system catheter is designed to combine softness with strength, helping to reduce vascular complications and further ensure stability and precision. Accompanied by Alwide™ Balloon Catheter and Alpass™ Introducer Set, the VitaFlow® System further provides surgeons with a comprehensive ‘full-set’ therapeutic solution while also providing surgeons with enhanced control and usability during surgery.
Shouyan Lee the President of MicroPort® CardioFlow commented, “Since launch, the VitaFlow® System has won praise from healthcare professionals since it was granted a registration certificate from the National Medical Products Administration of China (NMPA) in July 2019. Over the past year, use of the device has grown rapidly and brought benefit to many patients with aortic valvular diseases.
As Argentina is the most developed market for Transcatheter Aortic Valve Replacement (TAVR) in South America, this approval marks a major milestone in MicroPort® CardioFlow’s overseas development. In the future, MicroPort® CardioFlow will further expedite our expansion in the international market to ensure more patients and doctors have access to a high-quality solution to aortic valvular diseases”.