MicroPort Medical has recently completed the patient enrolment of the pre-market clinical trial of its self-developed VitaFlow transcatheter aortic valve and delivery system (VitaFlow), which is three months prior to the scheduled completion date.
The clinical trial is a prospective, multicentre trial, aiming at assessing the safety and efficacy of VitaFlow in the treatment of severe aortic stenosis. It was organised by Junbo Ge (Zhongshan Hospital of Fudan University, Fudan, China) led 11 domestic hospitals to complete the clinical trial.
According to a press release, MicroPort’s VitaFlow adopts world-class techniques with better coaxiality and stability during valve deployment. Its skirt designs to reduce perivalvular leak and heart block. Meanwhile, motorised handle of the delivery system simplified operation. The press release reports that the completion of patient enrolment for VitaFlow clinical trial marked a significant step forward for MicroPort in the field of aortic valve research.
In August 2016, VitaFlow was granted the “Green-Path” by the China Food and Drug Administration (CFDA)—a special fast-track procedure for innovative medical devices to gain CFDA approval, which will significantly shorten the approval time for VitaFlow. It is expected that the launch of VitaFlow will provide a more safe, effective, and cost-effective solution for patients with severe aortic stenosis.