VitaFlow® Transcatheter Aortic Valve and Delivery System Receives NMPA Approval

Shanghai, China - On July 12th, Shanghai MicroPort CardioFlow Medtech Co., Ltd. ("MicroPort® CardioFlow"), which is a subsidiary of Shanghai MicroPort Medical (Group) Co., Ltd. (“MicroPort®”), received the registration certificate for the independently developed VitaFlow® Transcatheter Aortic Valve and Delivery System (“VitaFlow®”) from National Medical Products Administration of China (NMPA). VitaFlow® is the sixth product of MicroPort® which has successfully obtained the NMPA approval after being granted entry into the Special Review and Approval Procedure for Innovative Medical Devices, which is also known as the Green Path, with NMPA.

VitaFlow® is composed of aortic valve, delivery system, loading tool, balloon catheter and introducer set. Its aortic valve is the first approved to be made of self-expanding bovine pericardial leaflets in China. It applies an innovative design of double layer skirts to more effectively reduce the occurrence of paravalvular leak. The hybrid density cells and nitinol frame enable the valve to effectively expand the calcified leaflets and ensure a stable and precise valve coaxial deployment. The large cells enable coronary access for PCI treatment. VitaFlow® also applies motorized delivery system to facilitate the manipulation of guidewire while deploying the valve by one operator. The delivery system catheter is designed with extraordinary combination of softness and strength, both reducing vascular complications and ensuring the stability and precision of deployment. VitaFlow® is accompanied with MicroPort® CardioFlow’s independently developed balloon catheter and introducer set to further provide the doctors with a comprehensive integrated therapeutic solution to increase the safety and efficacy of the procedure.

The aortic valve stenosis is one of the most common and critical valve diseases among the elderly people, with the prevalence rate increasing significantly with age. In the western countries, the prevalence rate of aortic valve stenosis among the age group of 65 and above is about 2%, with the rate increasing to about 4% among the age group of 85 and above. The patients would have a median survival of two to three years without timely intervention. The Transcatheter Aortic Valve Implantation (TAVI) is an interventional procedure that has been used in clinical practice over the recent years, which provides an ideal alternative therapeutic solution for the high-risk and severe patients suffering from aortic valve stenosis who are not qualified for surgical aortic valve replacement. Currently, about 350,000 patients in over 60 countries have undergone TAVI. With an increasingly aging population and expanding indications, it is estimated that the TAVI cases will increase by 400% globally in the next 10 years, with the global TAVI market exceeding 5 billion dollars in sales by 2021.

The patients suffering from severe aortic valve stenosis amount to about 2.8 million in China. Although the interventional treatment of valve diseases started late in China, it has recorded very rapid growth. Since the first TAVI procedure was performed in 2010, nearly 2,000 TAVI cases have been performed at over 100 hospitals in more than 20 Chinese provinces. The devices used in TAVI are well positioned for business development in a huge market in China.

As a leading provider of high-end medical devices, MicroPort® launched the independent R&D of the valve system of VitaFlow® in 2010. The device was granted entry into the Green Path in 2016. The NMPA approval for VitaFlow® is set to help more patients suffering from severe valve stenosis in China benefit from the device.