Beijing Anzhen Hospital and HeartCon Medical Successfully Launch Clinical Trial of Extracorporeal Ventricular Assist System

On June 23, 2022, Beijing Anzhen Hospital, Capital Medical University (hereinafter referred to as Anzhen Hospital) and Suzhou magAssist Medical Technology Co., Ltd. (hereinafter referred to as magAssist) held a grand launch meeting for the clinical trial project of the extracorporeal ventricular assist system through an online connection between Beijing and Suzhou.

This is the second clinical research project launched after Anzhen Hospital and magAssist initiated clinical research and development cooperation on the membrane oxygenator (ECMO) and its accessories project on March 22 of the same year.

Vice President of Anzhen Hospital, Hou Xiaotong, Deputy Director of the Heart and Lung Transplant Center of Anzhen Hospital, Gong Ming, and Director of the Scientific Research Department of Anzhen Hospital, Yue Hualan, led three clinical expert teams from the Cardiac Surgery, Cardiology, and ECMO departments to attend the launch meeting at the Beijing venue. Dr. Xu Boling, founder of magAssist, Yan Yifan, Vice President of magAssist, and Wu Nan, Vice President of magAssist, led relevant teams from the R&D and Clinical departments of magAssist to participate in the launch meeting of this clinical trial project via online connection from the Suzhou branch venue.

 Anzhen Hospital and magAssist Ventricular Assist System Clinical Trial Project Launch Conference - Beijing Venue

Anzhen Hospital and magAssist Ventricular Assist System Clinical Trial Project Launch Conference - Suzhou Branch

Deputy Dean of Anzhen Hospital, Hou Xiaotong, Delivered the Opening Speech at the Launch Conference, Introducing the Approved and Marketed Products and Technological Iterations in the Field of Extracorporeal Ventricular Assist Systems Abroad, as well as the Current Status and Challenges in the Research, Development, and Application of Technologies for Heart Failure Treatment in China. Due to the absence of domestically produced products with independent intellectual property rights, all products currently used in clinical settings in China are foreign-made, with technology still lingering in the first and second generations of development. Alternatively, ECMO is used as a substitute for left ventricular assist in post-cardiac surgery patients. However, ECMO causes significant damage to the human body, has strong hemolytic properties, and its postoperative management is relatively complex.

This magAssist extracorporeal ventricular assist system utilizes third-generation full magnetic levitation technology. Compared to first-generation mechanical bearing pumps and second-generation hydrodynamic suspension pumps, the third-generation full magnetic levitation technology eliminates contact between the bearings and blood, reducing the risk of thrombosis and offering superior hemocompatibility and stronger shock resistance. Compared to ECMO, the extracorporeal ventricular assist system has more pronounced advantages in terms of hemocompatibility, nursing difficulty, and cardiac unloading, allowing it to better serve suitable patients.

Vice President Hou Xiaotong emphasized that clinical research must strictly adhere to clinical enrollment requirements while accelerating the completion of enrollment, data analysis, and other tasks. This will expedite the research progress of extracorporeal ventricular assist devices in China, laying a solid medical foundation for saving more patients with heart failure in China.

Dr. Xu Bolei, founder of magAssist, introduced the current research and development progress of magAssist's extracorporeal ventricular assist device. magAssist's extracorporeal ventricular assist device is also known as the extracorporeal fully magnetically levitated artificial heart (MoyoAssist).^®Extra-VAD is China's first self-developed, fully magnetically levitated artificial heart produced in China. To date, magAssist has made significant progress in clinical research across multiple centers, saving several patients. magAssist will deepen its collaboration with Anzhen Hospital to comprehensively and efficiently complete the clinical research for China’s first domestically intellectual property-owned extracorporeal ventricular assist system, promoting its early registration and market launch to serve a wide range of patients in China. Furthermore, it aims to share China’s successful experiences with the world.

magAssist Vice President Yan Yifan provided the expert physicians present with a detailed product introduction and usage demonstration, while also answering their questions about the product in real time.

Subsequently, Gong Ming, Deputy Director of the Cardiothoracic Transplant Center at Anzhen Hospital, provided a detailed explanation of the clinical trial protocol and systematically reviewed the key considerations in study design. Participants from both locations engaged in thorough discussions on critical issues.

The clinical launch meeting of the extracorporeal ventricular assist system has successfully concluded, marking the official start of the clinical trial of Beijing Anzhen Hospital and magAssist's extracorporeal ventricular assist system, with the recruitment of participants now beginning.