MicroPort CardioFlow Medtech (CardioFlow) has received CE-MDR certification for VitaFlow Liberty, its second-generation transcatheter aortic valve and retrievable delivery system.
The certification marks a major milestone for the transcatheter aortic valve implantation (TAVI) device for heart valve treatments and sets a new benchmark in heart valve treatments.
VitaFlow Liberty is designed to prevent open-heart surgery and provide several benefits to patients, such as minimal trauma, quick recovery, and enhanced quality of life.
It is the world’s only electric retrievable transcatheter aortic valve system, which is widely used as a preferred choice for patients with aortic heart valve disease, said CardioFlow.
Before the commercial launch in the EU market, the company conducted pre-market clinical implantations of VitaFlow Liberty in Ireland, Denmark, and the UK.
The clinical implantations were performed at Galway University Hospital in Ireland, Copenhagen University Hospital in Denmark, and St Thomas’ Hospital and NHS Trust in the UK.
CardioFlow president Jeff Lindstrom said: “The certification of VitaFlow Liberty by the CE regulatory body under MDR, is a testament to CardioFlow’s world-class R&D, quality, and clinical capabilities.
“This recognition will expedite the global clinical adoption of the VitaFlow series along with other innovative products, advancing CardioFlow’s globalisation strategy.
“This achievement also positions us to make a more substantial contribution to developments in the field of heart valve interventions, ultimately benefiting patients across the globe.”
According to recently published clinical data, VitaFlow series valves showed superior long-term clinical performance in high-surgical risk patients with severe aortic stenosis.
In the long-term, VitaFlow showed promising outcomes in all-cause mortality, cardiac mortality, and permanent pacemaker implantation rates, compared to other similar studies.
CardioFlow said that its VitaFlow Liberty system is designed with flexibility and a 360° range of motion when treating complex anatomical patients with severe angled aortic arch deformities.
The valve can be fully retrieved and repositioned when released to 75% and provides up to three retrievable opportunities for each procedure, further optimising the implantation.
In addition, the system ensures the stability of valve release, reduces valve displacement, and makes the procedure more controllable.
The company has submitted a CE application for three other products, including the Alwide Plus Balloon Catheter, the AnchorMan Left Atrial Appendage Closure System and the AnchorMan Left Atrial Appendage Access System.
CardioFlow chairman Guoming Chen said: “Securing the EU CE-MDR marking for VitaFlow LibertyTM is not just a passport for the product’s entry into the European market, it also represents a significant milestone in CardioFlow’s history and global roadmap.
“This achievement will assist in diversifying the company’s sources of sales revenue and bolstering our overall competitiveness with a steadfast commitment to world-class product innovation.”
TAVI procedures leader Ole De Backer said: “The overall release process of VitaFlow Liberty is notably stable, ensuring precise positioning. This stability is especially crucial in patients with small left ventricles, where VitaFlow Liberty consistently achieves stable and precise deployment, fully demonstrating its distinct advantages.”
