CardioFlow Medtech Launches Prospective Multicenter Study on VitaFlow Liberty™ for Severe Aortic Valve Insufficiency

Wuhan, China, 28 February 2022 — MicroPort CardioFlow Medtech Corporation (CardioFlow Medtech) has recently launched a prospective multicenter post-marketing clinical study on the treatment of severe aortic valve insufficiency using its VitaFlow Liberty™ Transcatheter Aortic Valve and Retrievable Delivery System (VitaFlow Liberty™).

The study aims to observe and evaluate the safety and efficacy of VitaFlow Liberty™ in the treatment of severe aortic valve insufficiency in the real world. It is being led by the Union Hospital of Tongji Medical School, Huazhong University of Science and Technology (Wuhan Union Hospital), with the participation of leading cardiovascular centers across China, Prof. Nianguo Dong of Wuhan Union Hospital serving as the principal investigator (PI) of the study. This study will also undertake a five-year post-operative follow-up of patients implanted with VitaFlow Liberty™ to evaluate the medium-to-long term performance of the retrievable aortic valve and retrievable delivery system.

At the start of the launch ceremony, Prof. Mingxing Xie of Wuhan Union Hospital highlighted the significance of this study. According to Prof. Xie, although the use of TAVI therapy in patients with aortic stenosis has now been well established, and its treatment strategy has been included in first-line guidelines in China and abroad, there is still a lack of evidence-based medical investigations, especially randomized, double-blind controlled trials on the effectiveness and safety of TAVI among patients with aortic regurgitation. The goal of this multicenter clinical trial is to generate new evidence-based knowledge for theoretical medicine with regards to the clinical application of TAVI in patients with aortic valve diseases, which will further provide guidance for clinical practice.

“Nothing, not even mountains and seas, can separate those with a shared vision,” said Prof. Xie, as he urged clinicians to leverage of the rapid advancement of diagnosis and treatment technology of structural heart disease, and to apply their professional knowledge to save more patients and meet new challenges with a pioneering spirit, modern ideas, sophisticated skills, and a down-to-earth attitude.

Prof. Xiaoke Shang, from Wuhan Union Hospital, presented detailed information on the background, design, targeted product, pre-market clinical trial data and enrollment criteria. The study will have 132 subjects in total, with the primary endpoint of a composite of all-cause death, stroke, and rehospitalization for heart failure at 1 year after TAVR. The study is scheduled to launch at each sub-center from May to June 2022 for implementation within 10 months after the official launches.

As the leading organization of this study, Wuhan Union Hospital has successfully implanted VitaFlow Liberty™ during TAVI procedures in more than 100 patients with aortic valve insufficiency. In order to promote experience sharing and academic exchange of TAVI technique, Prof. Yucheng Zhong shared his experience and techniques of applying VitaFlow Liberty™ to treat patients with simple aortic regurgitation (AR) at Wuhan Union Hospital. According to Prof. Zhong, TAVI for aortic regurgitation (AR) is a difficult procedure involving three common technical challenges in clinical practice: valve migration, excessive depth of valve implantation, and high valve-in-valve ratio. VitaFlow Liberty™ is designed in such a way that it could mitigate the risk of all three of these scenarios.

By virtue of its unique and innovative structure, as well as its fast, stable and precise release and retrieval, VitaFlow Liberty™ has further accomodated the clinical need for a safer, more efficient and stable solution and enhanced treatment outcomes since its approval in September 2021. The retrieval system also provides a better control experience for repositioning, giving the doctor more confidence when performing TAVIs. CardioFlow Medtech will keep innovating products and improve clinical outcomes while collecting evidence-based medical data, in order to deliver inclusive and total medical solutions for the treatment of structural heart disease in the future.

About CardioFlow Medtech Corporation:

Founded in 2015, Cardioflow Medtech (stock code: 02160), a subsidiary of MicroPort Scientific Corporation (stock code: 00853), focuses on the research, development and commercialization of innovative transcatheter and surgical solutions for valvular heart diseases. In light of today’s enormous, rapidly growing yet severely under-penetrated heart valve medical device market, Cardioflow Medtech has seized this opportunity to strategically focus its product portfolio on the treatment of the most common aortic and mitral valve diseases, including aortic stenosis and mitral regurgitation.