VitaFlow Liberty™ von CardioFlow erhält EU CE-MDR-Zertifizierung und treibt weltweite Expansion voran

Wednesday, June 19, 2024

MicroPort® CardioFlow Medtech Corporation has recently announced that its second-generation transcatheter aortic valve implantation (TAVI) device, the VitaFlow Liberty™ Transcatheter Aortic Valve and Retrievable Delivery System, has earned EU CE-MDR certification.

This certification highlights VitaFlow Liberty™ as a pioneering solution in TAVI technology, setting new standards for transcatheter heart valve treatment.

Over 47 million people worldwide are affected by aortic valve stenosis and regurgitation, with the incidence of these conditions increasing due to the aging population.

CardioFlow’s TAVI solution avoids open-heart surgery and provides benefits such as minimal trauma, rapid recovery, and improved quality of life, making it an increasingly popular choice for aortic valve disease patients.

CardioFlow, a leading medical device company headquartered in Shanghai, China, has been at the forefront of structural heart disease innovation since its early days.

Listed on the Hong Kong Stock Exchange in February 2021, the company offers a diverse product portfolio developed through independent and collaborative research.

This includes transcatheter aortic, mitral, and tricuspid valves, left atrial appendage closures, and related accessories. With its strong technological capabilities and innovative approach, CardioFlow has launched several successful TAVI products globally. VitaFlow Liberty™ is notable as the world’s only electrically retrievable transcatheter aortic valve system.

The VitaFlow™ TAVI solution and its accessory, the Alwide™ balloon catheter, have been deployed in nearly 700 central hospitals across ten countries and regions, treating over 10,000 aortic valve disease patients worldwide.

Clinical data for the VitaFlow™ series valves were showcased at PCR London Valves 2023, a leading conference on structural heart disease. These data demonstrated the long-term clinical performance of VitaFlow™, aligning with international standards.

In high surgical risk patients with severe aortic stenosis, VitaFlow™ showed promising results in overall mortality, cardiac mortality, and the rate of permanent pacemaker implantation over seven years. At the conference, Dr. Darren Mylotte from Galway University Hospitals in Ireland praised the excellent data and discussed the benefits of VitaFlow Liberty™ with its motor-equipped delivery system.

This system’s flexibility and 360° range of motion allow precise valve positioning even in patients with complex anatomies and severely angled aortic arches. The valve can be fully retrieved and repositioned when 75% deployed, with up to three retrieval attempts per procedure, enhancing implantation success. Additionally, the system provides stable valve release, reducing displacement, and improving procedural control.

Before its launch in the EU, VitaFlow Liberty™ was clinically tested at Galway University Hospital in Ireland, Rigshospitalet (Copenhagen University Hospital) in Denmark, and St. Thomas' Hospital and Brighton & Sussex University Hospitals NHS Trust in the UK, receiving high praise from clinical experts.

"The release process of VitaFlow Liberty™ is highly stable and ensures precise positioning. This is especially important for patients with small left ventricles. VitaFlow Liberty™ reliably demonstrates precise deployment, showcasing its clear advantages. We anticipate positive outcomes for a wider patient group following CE certification." The European post-launch clinical project is expected to begin this year.

In line with its global expansion plan, CardioFlow has also achieved significant milestones with the CE filing for three other products: the Alwide™ Plus Balloon Catheter, a key accessory for aortic valve procedures, and the AnchorMan™ Left Atrial Appendage Closure System and Access System, both developed by its subsidiary CardioAdvent.