CardioFlow's VitaFlow Liberty™ Earns EU CE-MDR Approval, Marking a Step Forward in Global Expansion Plans

Tuesday, June 18, 2024

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

This certification highlights VitaFlow LibertyTM as a pioneering TAVI solution, setting a new benchmark in transcatheter heart valve treatments.

Aortic valve stenosis and regurgitation affect over 47 million patients globally, with prevalence increasing due to an aging population. CardioFlow's TAVI solution is increasingly preferred for aortic heart valve disease due to benefits such as avoiding open-heart surgery, minimal trauma, quick recovery, and enhanced quality of life.

CardioFlow, headquartered in Shanghai, China, is a leading innovative medical device company listed on the Hong Kong Stock Exchange since February 2021.

The company has a diverse product pipeline from independent and collaborative research, covering structural heart devices like transcatheter aortic, mitral, and tricuspid valves, left atrial appendage occludes, and accessories.

Leveraging its technological expertise, CardioFlow has successfully launched several TAVI products globally, including the VitaFlow LibertyTM, the world's only electric retrievable transcatheter aortic valve system.

The VitaFlowTM series, paired with the AlwideTM series Balloon Catheter, has been adopted in nearly 700 core hospitals across 10 countries, treating over 10,000 patients with aortic valve disease worldwide.

Clinical data from the VitaFlowTM series presented at the PCR London Valves 2023 highlighted its exceptional long-term clinical performance, meeting international top-tier standards.

The results in high surgical risk patients with severe aortic stenosis demonstrated promising outcomes in mortality rates, cardiac mortality, and pacemaker implantation, surpassing outcomes from similar studies.

Pre-market clinical implantations of VitaFlow LibertyTM at leading hospitals in Ireland, Denmark, and the United Kingdom garnered high praise from clinical professionals.

These trials showcased the device's stability and precise positioning capabilities, particularly beneficial in treating patients with complex anatomical conditions.

President of CardioFlow, underscored the significance of VitaFlow LibertyTM's CE-MDR certification, affirming the company's commitment to world-class R&D and clinical capabilities.

This milestone is expected to accelerate global adoption of the VitaFlowTM series and other innovative products, furthering CardioFlow's globalization strategy.

Chairman Guoming Chen emphasized that achieving EU CE-MDR marking for VitaFlow LibertyTM marks a pivotal milestone in CardioFlow's history and global expansion plans, enhancing revenue diversification and competitive edge through ongoing product innovation.

CardioFlow's VitaFlow LibertyTM CE-MDR certification represents a significant advancement in transcatheter heart valve technology, poised to benefit patients worldwide with its advanced features and proven clinical efficacy.