MicroPort CardioFlow Medtech Corp. today announced that it received CE mark for its second-generation aortic valve implant.
The VitaFlow Liberty transcatheter aortic valve implant (TAVI) device and retrievable delivery system received EU CE-MDR certification. CardioFlow’s implant helps patients avoid open-heart surgery and delivers minimal trauma, quick recovery and enhanced quality of life.
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VitaFlow can assist the valve to position easily due to its flexibility and 360° range of motion. It’s also fully retrievable and can be repositioned when released to 75%, providing up to three retrievable opportunities for each procedure. The company says it can also effectively ensure the stability of valve release, reduce valve displacement and make procedures more controllable.
Shanghai, China–based CardioFlow said in a news release that VitaFlow Liberty is the world’s only electric retrievable TAVI system. More than 700 hospitals in 10 countries and regions have used the implant, with its Alwide balloon catheter, to date. The company reports more than 10,000 patients with aortic valve disease treated with the system worldwide.
Before launching in Europe, CardioFlow conducted premarket implants in Ireland, Denmark and the UK. The company said clinical data highlighted long-term performance, including promising outcomes in all-cause mortality, cardiac mortality and permanent pacemaker implantation rates for aortic stenosis patients over seven years.
“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,” said Jeff Lindstrom, CardioFlow president. “This recognition will expedite the global clinical adoption of the VitaFlow series along with other innovative products, advancing CardioFlow’s globalization strategy. This achievement also positions us to make a more substantial contributions to developments in the field of heart valve interventions, ultimately benefiting patients across the globe.”
