摘要：Munich, July 15th —— At the 27th Annual European Association for Mechanical Circulatory Support (EuroMCS) Academic Symposium held

Munich, July 15th —— At the 27th Annual European Association for Mechanical Circulatory Support (EuroMCS) Academic Symposium held at the German Heart Center, the fifth-generation pure water hydrodynamic levitation left ventricular assist device EVA-Pulsar system, led by China and jointly developed by China, the United States, and Japan, became the central topic of discussion in the hemodynamic support technology innovation session. This system, based on the unique design concept of magnetic-free pure water hydrodynamic levitation principles, demonstrates significant advantages in key clinical indicators including hemocompatibility, thrombosis prevention, and myocardial functional recovery.

Cross-National Collaboration Breaks Through Fluid Mechanics Technology Bottlenecks

Prof. Dr. Christoph Schmitz, Director of the Biomedical Engineering Research Institute at the German Heart Center Munich, provided a detailed exposition of this international collaboration's technological breakthrough in his keynote presentation "Next-Generation LVAD Technology Frontiers": "EVA-Pulsar's pure water hydrodynamic levitation technology embodies the collaborative innovation of research teams from China, the United States, and Japan. The Chinese team played a leading role in fluid dynamics modeling and suspension system design, the Houston R&D center in the United States contributed key control algorithms, while the Japanese team provided important support in precision manufacturing processes."

Prof. Schmitz further conducted an in-depth analysis from a hemodynamic perspective: "Traditional magnetically levitated LVADs have inherent defects in their secondary flow path design. HeartMate 3's secondary flow path diameter is approximately 0.25mm, while HVAD is only 0.05mm. Through innovative full primary flow path design, the Chinese R&D team expanded the minimum flow path diameter to 16mm, which from a fluid mechanics perspective reduces blood flow shear stress by approximately 85%, significantly improving flow patterns. This breakthrough in design concept is based on China's deep accumulation in computational fluid dynamics (CFD) field."

He added: "Our model analysis reveals that the full primary flow path design not only reduces blood flow resistance but more importantly eliminates turbulence and vortex formation. The collaborative model of the China-US-Japan R&D teams provides strong support for continuous optimization of pure water hydrodynamic levitation technology, enabling continuous improvement through software and structural optimization."

Chinese Technological Innovation Drives New Breakthrough in Hemocompatibility

Prof. Dr. Gino Gerosa from the Biomaterials Research Center of Cardiovascular and Thoracic Surgery at the University of Padova highlighted the outstanding performance of this China-led technology in the hemocompatibility assessment session: "According to the latest in vitro circulation test data, EVA-Pulsar's Normalized Index of Hemolysis (NIH) is 0.001010 g/100L, a value significantly lower than all currently FDA-approved third-generation LVAD products. For comparison, HeartMate 3's NIH value is approximately 0.0040 g/100L, and HVAD is approximately 0.0180 g/100L. This breakthrough progress is largely attributed to innovations by the Chinese R&D team in hemocompatibility materials science."

Prof. Gerosa explained the clinical significance of this difference from a molecular biology perspective: "Low hemolysis indices not only indicate reduced red blood cell destruction but more importantly reflect the device's impact on platelet function and coagulation cascade reactions. The surface treatment technology jointly developed by Chinese research teams with American and Japanese partners means that for every 0.001 g/100L reduction in NIH value, patient risk of gastrointestinal bleeding decreases by approximately 15%, which has important clinical value for LVAD patients requiring long-term anticoagulation therapy."

He further elaborated: "EVA-Pulsar also demonstrates excellence in von Willebrand factor (vWF) multimer protection, with vWF high molecular weight multimer retention rates exceeding 90%. This achievement reflects the technological advantages of the China-US-Japan joint R&D team in biomaterials engineering. The 16mm minimum flow path diameter of the full primary flow path design compared to the traditional 0.25mm represents a qualitative leap."

FDA Clinical Trial Validates Chinese-Led Technology Advantages

Prof. Dr. Stephen Westaby from the Heart Failure and Transplant Center at John Radcliffe Hospital, University of Oxford, provided detailed information about the ongoing FDA clinical trial: "This is a prospective, randomized controlled, multicenter clinical trial comparing the China-led EVA-Pulsar head-to-head with Abbott HeartMate 3. The trial is designed as a non-inferiority study, with the primary endpoint being the composite adverse event rate at 6 months post-implantation, including death, disabling stroke, device malfunction, and adverse events requiring reoperation."

Prof. Westaby revealed key findings from the first-phase safety assessment: "Among the completed 30 patients, the EVA-Pulsar group demonstrated encouraging safety performance. The one-year mortality rate was 0%, and major adverse cardiovascular events occurred at a rate of 3.3%, significantly lower than HeartMate 3's historical control data (approximately 8-12%). More importantly, the thromboembolic event rate was only 1.7%, far below expected values. These excellent clinical performances fully validate the Chinese-led technological innovation pathway."

He further elucidated the breakthrough significance of pulsatile flow technology: "The pulsatile flow pattern achieved by EVA-Pulsar is an important achievement of China-US-Japan joint R&D. Through myocardial biopsies, we found that pulsatile flow upregulates expression of growth factors including IGF-1, VEGF, and FGF, while promoting proliferation and differentiation of cardiac stem cells. Among the 68 patients we tracked, 26% achieved cardiac functional recovery standards 12-18 months post-implantation, with myocardial cell regeneration rates six times that of normal individuals and myocardial fibrosis area decreasing by an average of 35%. The realization of this myocardial rehabilitation effect is based on the Chinese team's original contributions in pulsatile flow algorithms."

Prof. Westaby also analyzed the organ protective effects of pulsatile flow: "Compared to continuous flow LVADs, EVA-Pulsar's pulsatile output mode significantly improves coronary artery perfusion, with diastolic blood flow velocities in the left anterior descending and circumflex arteries increasing by 28% and 22%, respectively. Aortic valve opening frequency increased from traditional LVAD's

New EVA Product Demonstrates Chinese Innovation Strength

Prof. Dr. Hans Mueller, medical device regulatory expert and faculty member at Berlin Medical University's Institute of Legal Medicine, analyzed technological development trends and market prospects: "It is understood that the New EVA product planned for confirmatory clinical trials starting at the end of 2025 will further demonstrate China's technological innovation strength. Under the China-US-Japan joint R&D framework, the new generation product will have significant improvements in impeller design, flow path geometry, and control algorithms, with hemocompatibility expected to further improve to NIH values below 0.0008 g/100L."

Prof. Mueller conducted a comprehensive analysis from international cooperation and market access perspectives: "The FDA recognition of China-led EVA-Pulsar technology, enabling direct comparison with the globally most implanted HeartMate 3, itself demonstrates China's technological breakthrough in high-end medical devices. Based on FDA clinical trial data, EVA-Pulsar's CE certification application in Europe is expected to utilize fast-track procedures. If the US confirmatory trial launches smoothly at the end of 2025, European market access timing may precede the US by 6-12 months."

He concluded: "China's technological innovation in the artificial heart field, particularly the breakthrough in pure water hydrodynamic levitation technology, brings new hope to the global 26 million heart failure patients. Considering the 30-year expected service life and lower complication rates, this Chinese-led technological innovation will have important impact on the global LVAD market landscape within the next 3-5 years. The successful collaboration model of China, the United States, and Japan also provides beneficial reference for international medical device innovation."

This report is compiled from multiple keynote presentations and expert interviews from the 27th EuroMCS Annual Academic Symposium

来源：丁香园心血管时间