Shanghai, China - Shanghai MicroPort Medical (Group) Co., Ltd. ("MicroPort®") has recently completed the patient enrollment 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, multi-center trial, aiming at assessing the safety and efficacyof VitaFlow™ in the treatment of severe aortic stenosis. The clinical trial was organized by Professor Junbo Ge, an academician of Chinese Society of Sciences and a renowned cardiologist. Zhongshan Hospital of Fudan University, led eleven domestic hospitals to complete the clinical trial.
Aortic stenosis is one of the most common and severe valvular heart diseases，and the prevalence rate increases significantly with ages. Transcatheter Aortic Valve Implantation ("TAVI") is a revolutionary procedure to bring better treatment for severe symptomatic aortic stenosis patients who can't afford surgery. Up to now, more than 250,000 patients in more than 65 countries received TAVI treatment, while the amount of TAVI cases reached 71,000 in 2015. With the aging population and expanding indications, TAVI will increase four-fold in the next 10 years. The first TAVI case was introduced to China in 2010 by Professor Junbo Ge, however so far only 650 cases have been performed in clinical studies since there is no transcatheter aortic valve product approved in Chinese market.
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, motorized handle of the delivery system simplified operation.
The completion of patient enrollment 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.