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MicroPort® CardioFlow Receives Approval for VitaFlow Liberty® and Alwide® Plus in Indonesia
2023-11-03
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Shanghai, China, MicroPort® CardioFlow Medtech Corporation (hereinafter referred to as MicroPort® CardioFlow, stock code: 02160.HK) has recently received marketing approval for its VitaFlow Liberty® Transcatheter Aortic Valve and Retrievable Delivery System (hereinafter referred to as "VitaFlow Liberty®" ) and Alwide® Plus balloon catheter (hereinafter referred to as "Alwide® Plus") from the Indonesian Ministry of Health (MOH).

 

VitaFlow Liberty® is the world’s only electric retrievable transcatheter aortic valve system, offering outstanding stability during procedure and hemodynamics post-procedure that will improve the quality of life for patients with aortic valve disease. It inherits the advantages of the VitaFlow® in terms of valve design, featuring a hybrid density self-expanding stent, bovine pericardial leaflets, and a high double-layer PET skirt design. This design offers robust radial force, improved coaxiality during deployment, and effectively reduces the incidence of perivalvular leakage post-procedure. Moreover, its breakthrough upgraded delivery system incorporates a unique and innovative double-reinforced spiral structure that ensures rapid, stable, and precise release and retrieval. This system also provides flexibility, allowing for 360-degree bending of the valve segment.

 

As an upgraded product of Alwide® Balloon Catheter, Alwide® Plus was approved by the China National Drug Administration (NMPA) on July 29, 2021, and its excellent performance has been widely recognized by the surgeons after its launch: 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 impact of prolonged blood flow blockage on cardiac function, reduce the pacing time, and lower the risk of surgery; significantly improved anti-puncture performance can further increase the safety of balloon dilatation while bring the surgeons a better experience.

 

Previously, MicroPort® CardioFlow’s VitaFlow® series and its accessory products have fully covered more than 500 core hospitals in China and more than 80 core hospitals in overseas countries since their listing. The approval of VitaFlow Liberty® and Alwide® Plus in Indonesia marks another milestone for MicroPort® CardioFlow in its internationalization journey, following Argentina, Colombia, Brazil, Thailand and Russia. In the future, MicroPort® CardioFlow will continue to focus on global market expansion and innovative research and development, dedicated to providing high-quality, universal total solutions for structural heart disease to more patients around the world.

 

Notes:

[1] MicroPort® CardioFlow Laboratory Test Data (compared with Alwide® valve balloon catheter)

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