CH-VAD Implantable Left Ventricular Assist System by Suzhou CH Biomedical Receives NMPA Approval, Ushering in a New Era for Heart Failure Treatment in China

On November 25, 2021, the CH-VAD Implantable Left Ventricular Assist System, independently developed by Tongxin Medical, officially received market approval from the National Medical Products Administration (NMPA) (Registration Certificate No.: Guo Xie Zhu Zhun 20213120987). This is the first domestically produced artificial heart with complete independent intellectual property rights to be approved by the NMPA in China, and also the first fully magnetically levitated artificial heart to receive NMPA approval globally. This milestone marks the commercial launch in China of ventricular assist devices based on the new generation of global technological pathways (fully magnetic levitation technology), ushering in a new era of heart failure treatment in China.

Dr. Chen Chen, Founder and CEO of the Company, stated, “Ventricular assist devices today are no longer just about saving lives; they also aim to enable patients to return to normal, active lives. Tongxin Medical is committed to leading global advancements in artificial heart technology. The CH-VAD has taken root and matured in an environment strongly encouraged by relevant government departments to foster technological innovation, and we are proud to offer it first to our fellow citizens in China.”

CH-VAD is the first domestically produced artificial heart with complete independent intellectual property rights in China to be approved under the “Special Approval Procedure for Innovative Medical Devices.” Regarding this approval, the National Medical Products Administration (NMPA) stated: “The core technology of this product is primarily based on fully magnetically levitated blood pump technology, which has secured multiple patents in China and the United States and represents a domestically pioneered medical device. Compared with similar international products, its key performance indicators have reached equivalent levels, while featuring a smaller blood pump size and reduced invasiveness during implantation. This product can meet the clinical needs in the field of surgical device-based treatment for heart failure in China and carries significant social benefits.”

CH-VAD Implantable Left Ventricular Assist System

The CH-VAD Implantable Left Ventricular Assist System consists of implanted components, external wearable components, peripheral components, and specialized surgical tools. It is an electromechanical device designed to partially substitute for the heart’s pumping function and maintain systemic circulation. Its core component is a blood pump that draws blood from the heart, increases its pressure, and delivers it into the aorta, thereby unloading the native heart and allowing it to rest while compensating for insufficient native cardiac output. The system is primarily indicated for the treatment of patients with end-stage severe heart failure, providing hemodynamic support for those with advanced, refractory left ventricular heart failure.

As the “crown jewel” of the cardiovascular industry, implantable artificial heart technology involves a high degree of interdisciplinary breadth and technical integration. CH-VAD adopts a next-generation fully magnetically levitated approach, achieving multidisciplinary design optimization by organically integrating magnetic levitation design with internal pump flow path design. This has resulted in a comprehensively original blood pump design encompassing two core technologies: rotor support and hydrodynamic design. All proprietary technologies underlying CH-VAD, from foundational techniques to higher-level constructs, are backed by clear independent intellectual property rights. The relevant foundational technologies have secured international patent protection, including patents in the United States, Europe, and Japan, laying a solid foundation for the product’s future global market expansion.

In terms of clinical research, the registered clinical trial for the CH-VAD implantable left ventricular assist system was led by Academician Hu Shengshou from Fuwai Hospital, Chinese Academy of Medical Sciences, as the Principal Investigator (PI), with collaborative contributions from Professor Dong Nianguo’s team at Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, and Professor Cheng Zhaoyun’s team at Central China Fuwai Hospital. As early as June 2017, Fuwai Hospital, Chinese Academy of Medical Sciences, successfully performed the first implantation of an implantable left ventricular assist device in China using the CH-VAD under a medical new technology research application. The first patient implanted with this device has returned to normal life for four and a half years and continues to maintain a good quality of life. Since the formal clinical trials began in March 2019, the survival rate data for CH-VAD to date suggests that it may achieve at least comparable survival outcomes to those of the latest generation of ventricular assist devices in real-world settings in the United States. Among related adverse events, the most critical are hemocompatibility-related events, including pump thrombosis, stroke, and gastrointestinal bleeding. To date, no such adverse events—pump thrombosis, stroke, or gastrointestinal bleeding—have occurred in any patients receiving the CH-VAD. Clinical trial results indicate that CH-VAD demonstrates comprehensive advantages in key performance indicators of VADs, including hemocompatibility, surgical invasiveness, infection resistance, system reliability, usability, and portability.

Tongxin Medical’s R&D prowess stems from its highly specialized team. Since its inception, Tongxin Medical has assembled a group of domestic and international experts and technical teams in the field of artificial hearts. The core members of the founding team boast over 25 years of experience in artificial heart research and development, along with extensive global perspectives. With its products achieving internationally leading levels in key performance indicators, Tongxin Medical has become a benchmark for technological advancement in the industry and earned a strong reputation among international peers as a pioneer in technological breakthroughs.

Dr. Lin Feng, Co-founder and Chief Technology Officer of the Company as well as President of its U.S. subsidiary, stated, “CH-VAD exemplifies the integration of medicine and engineering, driven by close collaboration between professional teams in China and abroad, to provide optimized treatment solutions for patients with end-stage heart failure. Given the unique and clear technical advantages of CH-VAD and its outstanding performance in domestic clinical trials, we are confident and optimistic about expanding its application globally, particularly in the European and American markets.”

Currently, China’s artificial heart market remains a blue ocean, poised for explosive growth. We are confident that CH-VAD will generate significant social and economic benefits during its commercialization process, saving more lives of patients with end-stage heart failure as it achieves large-scale clinical adoption. Tongxin Medical remains committed to leading global advancements in artificial heart technology and enhancing service offerings, enabling more patients with end-stage heart failure and their families to regain healthy and joyful lives.