The 8th European Association of Cardio-Thoracic Surgery (EACTS) Mechanical Circulatory Support (MCS) Summit was successfully held in Prague, Czech Republic from November 7 to 9, 2024. Dr. Chen Chen, founder of BrioHealth Technologies, along with Mr. Karl Nelson, Senior Clinical Operations Vice President, were invited to attend the summit.
During the “Industry Updates” session, Dr. Chen reported on the latest development in research and clinical application of the CH-VAD, an implantable fully magnetically levitated left ventricular assist system (LVAS) independently developed by BrioHealth Technologies, as well as the BrioVAD. Drawing on the global history of VAD technology development, particularly the experiences and the lessons from the early 20th-century development of fully magnetic levitation and hydrodynamic levitation technologies, Dr. Chen highlighted significant breakthroughs achieved by CH-VAD and BrioVAD in evaluating critical VAD performance indicators. His report was met with an enthusiastic response from the international community.
Dr. Chen Chen’s Report on BrioHealth Technologies’ Latest Product R&D and Clinical Progress
Dr. Chen began by discussing breakthroughs in miniaturization and blood-pump-related performance achieved by CH-VAD and BrioVAD. Compared with similar products on the international market, these two adopt a unique separate magnetically levitated structure. This design maximizes pump rotor size, while minimizing the pump’s physical dimensions, reducing implantation invasiveness, and laying a foundation for improved hemocompatibility and hemodynamic performance. Based on the structure, the two products made further advancements in the above two key performance indicators via optimized hydrodynamic design, especially the designs of central pillar guide structure, long blades and secondary flow path in the pump.
Dr. Chen emphasized that in magnetically levitated VAD technology, resistance to tilting during rotation is a weakness of the magnetically levitated rotor due to gyroscopic effect. The insufficient critical speed margin of ultra-small fully magnetically levitated pumps and poor stability at high flow rates are key challenges in the development of this type of VADs. Therefore, levitation stability is a key performance indicator to be reckoned with for magnetically levitated VAD and quality standards for magnetically levitated devices should be set to prevent arbitrariness in levitation stability assessment. The rotor of a fully magnetically levitated pump should be able to levitate in air and resist tilting motion while rotating. By employing multidisciplinary optimization, CH-VAD and BrioVAD not only achieve miniaturization but also improve key performance indicators such as hemocompatibility, hemodynamics, and levitation stability, demonstrating comprehensive performance advantage.
Dr. Chen also highlighted significant innovations in percutaneous driveline technology. With fully magnetically levitated VADs increasingly used to improve long-term survival and quality of life for advanced heart failure patients, long-term driveline infections have emerged as a critical concern. CH-VAD and BrioVAD employ microelectronic circuitry to minimize the number of wires while ensuring redundancy, resulting in the world’s thinnest percutaneous drivelines. This design significantly reduces the risk of driveline infections.
The clinical benefits of these features have been further verified through large-scale applications. Dr. Chen presented the latest clinical results from CH-VAD application in China, showing higher long-term survival rates compared to international large-scale clinical studies and INTERMACS data. Additionally, adverse events such as stroke, gastrointestinal bleeding, and driveline infections were reported at lower rates than those in international large-scale clinical studies and INTERMACS data, further underscoring the device’s leading clinical outcomes.
In addition, Dr. Chen provided an overview of the INNOVATE clinical trial for BrioVAD in the United States, which will use a randomized controlled approach to evaluate its efficacy and safety in the treating refractory heart failure.
During the summit, Dr. Chen and his team engaged in extensive and in-depth exchanges with international leaders in the industry of VAD, earning high praise, notably those from European experts. As BrioHealth Technologies continues to accelerate commercialization in China and initiate clinical trials in the United States, Europe has emerged as the next key focus for the company's global strategy. The summit played a significant role in enhancing the global academic influence of BrioHealth Technologies and advancing its efforts to enter international markets.
On August 7, People’s Daily published an article titled Domestic Fully Magnetically Levitated VAD Serving Patients, commending CH Biomedical for breaking the international technological monopoly for developing a domestically produced, fully magnetically levitated VAD with independent intellectual property rights. The device is currently available in nearly 40 hospitals across China, enabling over 140 patients with advanced heart failure to embark on a “new life”.
Recently, at the 2022 China Medical Development Conference—widely regarded as the country’s premier medical forum—the Chinese Academy of Medical Sciences (CAMS) released two lists: China’s Major Medical Achievements of the 21st Century and China’s Important Medical Advancements in 2021. As a global innovator in the field of Ventricular Assist Devices (VADs), CH Biomedical’s independently developed CH-VAD (NMPA (A) 20213120987) was included in China’s Important Medical Advancements in 2021.
From 9th to 14th of June 2019, the Gordon Research Conference was held in Barcelona, Spain. The conference theme this year was on Mechanical Circulatory Support (MCS) and brought together world-renowned doctors, scholars, and researchers in MCS field. Dr. Chen, CEO of the company, and Dr. Lin, CTO were invited to attend the conference and delivered a plenary speech.