MicroPort® CardioFlow Receives Approval for VitaFlow Liberty® in the EU

Shanghai, China, 9 May 2024 — MicroPort® CardioFlow has obtained CE certification for its second-generation transcatheter aortic valve implantation (TAVI) product, VitaFlow Liberty® Transcatheter Aortic Valve and Retrievable Delivery System (VitaFlow Liberty®). This establishes it as the first Chinese TAVI solution to receive approval in the EU.

Currently, there are over 47 million patients worldwide with aortic stenosis and aortic regurgitation. As the population ages, the prevalence of aortic valve diseases increases. For many of these patients and their healthcare professionals, TAVI is the preferred treatment. In response to significant market demand, MicroPort® CardioFlow has launched two generations of TAVI solutions: VitaFlow® and VitaFlow Liberty®, along with their accompanying surgical products. To date, these products have reached nearly 700 core hospitals in countries including China, Argentina, Colombia, Brazil, Thailand, Russia, Indonesia, and Saudi Arabia.

As the world's only electrically retrievable transcatheter aortic valve system, VitaFlow Liberty® inherits the design of VitaFlow®. It features a hybrid density self-expanding stent, bovine pericardial valve leaflets, and a high double-layer PET skirt design. This design offers robust radial support, improved coaxial release, and effectively reduces the incidence of perivalvular leakage and regurgitation post-operation. 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.

Moreover, three other products from MicroPort® CardioFlow, including the Alwide® Plus Balloon Catheter, the AnchorMan® LAA Closure system, and the AnchorMan® LAA Access System, have been submitted for CE marking registration, each making significant progress.

Mr. Jeffrey Lindstrom, President of MicroPort® CardioFlow, stated that, “Currently, the VitaFlow® series has been utilized in over 10,000 clinical applications worldwide. Moreover, the third generation of VitaFlow®, VitaFlow® III, has also recently demonstrated outstanding results in its First-In-Man clinical trial”. Mr. Guoming Chen, Chairman of MicroPort® CardioFlow, remarked that, “This CE certification is a critical milestone in our company’s global strategic expansion. It will significantly enhance our competitive position in the market.”

About MicroPort® CardioFlow

Founded in 2015, MicroPort® CardioFlow (MicroPort® CardioFlow Medtech Corporation; HKEX: 02160) is a leading medical device company focusing on research, development and commercialization of innovative transcatheter and surgical solutions for structural heart disease.

MicroPort® CardioFlow's self-developed transcatheter aortic valve implantation series products have successfully landed more than 600 core hospitals worldwide. Furthermore, MicroPort® CardioFlow has established a strategic Research and Development pipeline covering transcatheter aortic valve treatment products (iterative products), left atrial appendage closure systems (iterative products), transcatheter mitral valve treatment products, transcatheter tricuspid valve treatment products, and surgical accessories through in-house development and collaboration with global partners. MicroPort® CardioFlow strives to provide total solutions for structural heart diseases, dedicated to providing high quality therapeutic solutions to patients and physicians across the globe.

More information is available at www.en.cardioflowmedtech.com