CardioFlow’s VitaFlow Liberty TAVI/TAVR System Granted CE Mark Under European MDR

June 25, 2024—MicroPort CardioFlow Medtech Corporation (CardioFlow), which is headquartered in Shanghai, China, recently announced that it has received CE Mark certification under the European Union’s Medical Device Regulation (MDR) for the VitaFlow Liberty transcatheter aortic valve and retrievable delivery system. A European postmarket clinical project will be planned to start this year, advised the company.

VitaFlow Liberty is CardioFlow’s self-developed, second-generation transcatheter aortic valve implantation/replacement (TAVI/TAVR) device. It is an electric retrievable TAVI/TAVR system. CardioFlow’s VitaFlow TAVI/TAVR devices feature the company’s Alwide balloon catheter.

According to the company, premarket clinical implantations of VitaFlow Liberty were performed before the launch into the European Union at Galway University Hospital in Galway, Ireland; Rigshospitalet of Copenhagen University Hospital in Copenhagen, Denmark; St. Thomas’ Hospital in London, United Kingdom; and Brighton & Sussex University Hospitals NHS Trust in Brighton, United Kingdom.

Professor Ole De Backer, MD, led the TAVI procedures at Rigshospitalet.

“The overall release process of VitaFlow Liberty is notably stable, ensuring precise positioning,” commented Prof. De Backer in CardioFlow’s press release. “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. We look forward to its positive impact on a broader patient population following CE certification.”

Clinical data from the VitaFlow valves were presented at PCR London Valves 2023 course held November 19-21 in London, United Kingdom. The company stated that these results highlight VitaFlow’s long-term clinical performance. In high-surgical–risk patients with severe aortic stenosis, VitaFlow showed promising long-term outcomes in all-cause mortality, cardiac mortality, and permanent pacemaker implantation rates for patients for > 7 years compared to other similar studies.

During the PCR London Valves conference, Darren Mylotte, MD, from Galway University Hospital, discussed the data and advantages of VitaFlow Liberty and its motorized delivery system, which include the following: it assists valve positioning with flexibility and a 360° range of motion when treating complex anatomical patients with severe angled aortic arch deformities; it can be fully retrieved and repositioned when released to 75%; and it provides up to three retrievable opportunities for each procedure. Additionally, it can ensure the stability of valve release, reduce valve displacement, and make the procedure more controllable, noted the company’s press release.