Suzhou CH Biomedical Wins 2023 Jiangsu Provincial Science and Technology Award (First Class) for Fully Magnetically Levitated Artificial Heart
BrioHealth Solutions
Ventricular Assist Device Developer and Manufacturer
On November 7, the Jiangsu Science and Technology Conference and the Provincial Science and Technology Awards Ceremony were held in Nanjing.BrioHealth Solutions, as the first completing unit responsible for the development and clinical application of the implantable full magnetic suspension artificial heart, has won the "First Prize of Jiangsu Province Science and Technology Award.". As the highest award in the scientific and technological field of the province, this award mainly honors scientific and technological projects that have achieved significant economic or social benefits in areas such as technological invention, technological development, major engineering construction, promotion and transformation of scientific and technological achievements, high-tech industrialization, and social public welfare. The award has a rigorous evaluation process and fierce competition, making it highly prestigious. Each winning achievement represents the top level in its respective field.
Heart failure (HF), often referred to as the "cancer of heart diseases," is a major challenge faced by the global medical community. In China, there are over 10 million patients with heart failure, placing a heavy burden on the public health system. Although modern medicine has made significant progress in drug treatments, for patients with advanced heart failure, medications often fail to reverse the condition. Heart transplantation, on the other hand, is difficult to promote widely due to a shortage of donors, leaving current treatment options extremely limited. Internationally, artificial hearts have become a widely recognized effective treatment for end-stage refractory heart failure. However, the development of artificial hearts remains a global industry challenge. The most cutting-edge full magnetic levitation artificial heart technology is currently monopolized by overseas companies, leaving China in a long-standing void in this field.
The artificial heart is known as the "jewel in the crown" of medical devices and is one of the benchmarks for measuring a country's high-end medical device technology level. Since 2008, BrioHealth Solutions has been dedicated to the development of a new generation of fully magnetically levitated artificial hearts. Since its inception, the project has successively received support from key projects at various national, provincial, and municipal levels, including the "Eleventh Five-Year Plan" 863 Program Key Project of the Ministry of Science and Technology, the sub-topic of the "Twelfth Five-Year Plan" 863 Program Theme Project, the "Thirteenth Five-Year Plan" National Key Research and Development Program, and the Jiangsu Provincial Department of Science and Technology Achievement Transformation Key Technology Innovation Project. Through original innovation, BrioHealth Solutions successfully developed the new generation of fully magnetically levitated artificial heart, CiFu.®VAD (Model: CH-VAD) was approved for marketing by the National Medical Products Administration at the end of 2021, becoming the first domestically produced artificial heart to be approved for marketing in China, marking the entry of China's end-stage heart failure treatment into the "artificial heart era."
This landmark scientific and technological innovation achievement not only fills the gap in technology and application in China's artificial heart field, but also marks that China has entered the forefront of the international community in the artificial heart sector through systematic original innovation, surpassing the stage of following and learning.
CH-VAD has achieved international firsts in several key technologies such as magnetic levitation structure miniaturization, hydrodynamic optimization design, and percutaneous cable design. It has established a complete portfolio of independent intellectual property rights and completed patent layouts in multiple countries and regions including China, the United States, Europe, and Japan. The product has reached an internationally leading level in critical performance indicators for evaluating artificial hearts, such as implant invasiveness, blood compatibility, hemodynamic performance, and infection prevention.
Through the clinical application of CH-VAD, BrioHealth Solutions, in collaboration with the team led by Academician Shengshou Hu from Fuwai Hospital of the Chinese Academy of Medical Sciences, has established China's first technical standards for VAD surgical implantation, as well as a multidisciplinary, full-cycle clinical application system for VAD treatment across various scenarios. The related clinical outcomes of this product have reached an internationally leading level and have been published in high-level international academic journals. Meanwhile, based on CH-VAD, BrioHealth Solutions has developed a new-generation product, BrioVAD.®In 2024, it received clinical trial approval from the U.S. FDA, achieving a "zero breakthrough" for China in the field of high-end medical devices, and becoming the first and only active implantable medical device produced in China to be approved by the U.S. FDA for clinical trials.
The success of this project is a landmark for the research and development of high-end medical devices and industrial innovation in China, bringing new hope to millions of patients with end-stage heart failure in China and significantly improving the clinical treatment level for end-stage heart failure in the country. Internationally, this achievement has earned BrioHealth Solutions a reputation as a technological breakthrough leader and gained widespread international academic recognition. With BrioVAD®Clinical trials are about to be conducted in the United States, breaking the monopolistic pattern of the global artificial heart market and offering more choices to patients with advanced heart failure worldwide.
