Dr. Chen Chen of CH Biomedical Invited to Present at 2024 European Mechanical Circulatory Support Summit (EUMS)

The 18^th European Mechanical Circulatory Support Summit (EUMS) was successfully held from September 11^th to 14^th in Hannover, Germany. The summit served as a premier international platform dedicated to showcasing technological innovation, setting standards for best practices, and promoting multidisciplinary diagnosis and treatment strategies in the field of advanced heart failure. This year’s summit focused on highlighting best practices, adopting interdisciplinary approaches, ensuring an international perspective, encouraging intervention strategies, promoting interactive participation, and driving innovation. Dr. Chen Chen, founder of CH Biomedical, along with Mr. Karl Nelson, Sr. Clinical Operation VP, were invited to this prestigious event.
 

During the VAD UPDATES sub-session, Dr. Chen presented the latest research and development and clinical progress in CH-VAD and BrioVAD, the fully magnetically levitated left ventricular assist system independently developed by CH Biomedical. His presentation attracted significant attention and rave review from the global community.

Dr. Chen’s Presentation at EUMS 2024
 

During his presentation, Dr. Chen detailed the original development process of the company’s core products, CH-VAD and BiroVAD (Figure 2, Figure 3), highlighting that the initial prototypes were finalized in 2011 and introduced at the annual meeting of the American Society for Artificial Internal Organs (ASAIO). The products underwent several multidisciplinary optimization iterations before finalizing their design in 2015. CH-VAD and BiroVAD boast a range of globally pioneering technologies in, among others, magnetic levitation structure, hydrodynamic design, and percutaneous driveline design. They also indicate international leadership in key performance indicators for evaluating LVAD, including hemocompatibility, hemodynamics, implant invasiveness, anti-infectivity, as well as portability and reliability (Figure 4 to Figure 6).

Figure 2

Figure 3

Figure 5

As an internationally renowned expert in magnetically levitated VAD, Dr. Chen focused on the technical standards of full magnetic levitation during his presentation. He noted that the designs comply with the internationally recognized ISO 14839-3 standard for mechanical vibration, which requires a stability margin assessment for the vibration of rotating machinery equipped with active magnetic bearings (AMBs). He also believed that quality standards be set for magnetic levitation design in the field of VAD to eliminate arbitrary choice and explained that the rotor of a totally magnetically levitated blood pump should be able to levitate in the air and resist tilting movement when rotating.

Dr. Chen also disclosed key outcomes in the clinical application of CH-VAD in China. By September 1^st, 2024, the product had been used in 314 patients in China through active promoting internationally advanced concepts of full-process management and multidisciplinary cooperation and by observing the regulatory requirements for post-marketing visit. According to Kaplan-Meier survival analysis, 1-year, 2-year, and 3-year survival rates of the patients are 87.2%, 85.2%, and 82.4%, respectively (Figure 8), higher than data from large international clinical trials and INTERMACS while the incidence of key adverse events, such as stroke (Figure 9), gastrointestinal bleeding (Figure 10), and percutaneous driveline infection (Figure 11) are lower than those in large international clinical trials and INTERMACS.

Figure 8: Kaplan-Meier Survival

Figure 9: Freedom from first stroke

Figure 10: Freedom from first GI bleeding

Figure 11: Freedom from first driveline infection

Furthermore, Dr. Chen introduced the upcoming INNOVATE clinical study design and plans for BrioVAD in the United States. This study will employ a randomized controlled approach to evaluate the efficacy and safety of BrioVAD in treating refractory heart failure. 

In 2020, CH Biomedical became the first Chinese company specializing in implantable VAD to be invited to EUMS and has since consistently reported on the development and application of its products at the conference. In November 2021, CH-VAD, independently developed by CH Biomedical, became China’s first domestically developed LVAD approved by NMPA, marking a new era in the treatment of advanced heart failure in the country. In February 2024, BrioVAD obtained IDE approval from the U.S. FDA, becoming China’s first active implantable medical device approved by the FDA for access to clinical trials. Leveraging its international leadership in key performance indicators, CH Biomedical has achieved successive milestones in China and the United States, further accelerating its expansion into European and other global markets.