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CardioFlow receives the EU CE-MDR certificate for the VitaFlow Liberty TAVI device

Posted on by darion

CardioFlow’s VitaFlow Liberty transcatheter aortic valve and retrievable delivery system. Source: PRNewswire/MicroPort CardioFlow Medtech Corporation.

MicroPort CardioFlow Medtech (CardioFlow) has achieved EU CE-MDR certification for the VitaFlow Liberty transcatheter aortic valve and delivery system (VitaFlow Liberty).

This represents a milestone in the history of the second-generation transcatheter aortic valve implantation (TAVI) device for the treatment of heart valves.

CardioFlow CEO Guoming Chen said: “Securing EU CE-MDR marking for VitaFlow Liberty is not only a passport for the product to enter the European market, but also represents a significant milestone in CardioFlow’s history and global roadmap.

“This achievement will help diversify the company’s sales revenue streams and strengthen our overall competitiveness through our steadfast commitment to world-class product innovation.”

At the PCR London Valves 2023 conference, CardioFlow presented clinical data demonstrating compliance of the VitaFlow series valves with the highest international standards.

In patients with severe aortic stenosis, long-term clinical results with VitaFlow showed encouraging results in cardiac mortality, all-cause mortality, and permanent pacemaker implantation rates over a seven-year period.

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The VitaFlow Liberty System is designed for flexibility and 360° range of motion, even in patients with complex anatomical challenges such as severe angular aortic arch deformities.

Thanks to this feature, the valve can be fully recovered and repositioned up to three times during the procedure, streamlining the implantation process.

Prior to launch in the EU, VitaFlow Liberty underwent pre-market clinical implantation in several European hospitals.

These include University Hospital Galway, Rigshospitalet, St Thomas’ Hospital and University Hospitals Brighton and Sussex NHS Trust.

In addition, CardioFlow has planned a European post-marketing clinical project, which is expected to start this year.

The company’s global expansion plan also includes CE applications for other products, such as the Alwide Plus balloon catheter and the Anchorman left atrial appendage closure and access systems.