Corheart 6 Achieves Global-Leading 2-Year Survival Rate of 86% in First-Ever Prospective, Multicenter Long-Term Clinical Study of a Domestic Artificial Heart

Recently, a multicenter research paper led by the team of Academician Hu Shengshou from the National Center for Cardiovascular Diseases and Fuwai Hospital, Chinese Academy of Medical Sciences, titled “Application of the Next-Generation Magnetically Levitated Left Ventricular Assist System in Advanced Heart Failure: Two-Year Follow-Up Results from a Prospective, Multicenter Study,” was published in the European Journal of Cardio-Thoracic Surgery, a prestigious journal in the field of international cardiothoracic surgery.Data shows that,Domestically Produced Fully Magnetically Levitated Artificial HeartThe 2-year survival rate after Corheart 6 implantation reached 86%,Compared toThe 2-year survival rate for the international mainstream comparable product, HeartMate 3, is 76.9%., demonstrating excellent survival benefits and further bolstering the international competitiveness of Chinese-made artificial hearts.

This is the firstDomestically ProducedLong-Term Follow-Up Clinical Study of Artificial Hearts in the Registration Clinical Cohort, systematically analyzed and confirmed the long-term clinical value of China’s independently developed Corheart 6 fully magnetically levitated implantable left ventricular assist system. Industry experts pointed out that, compared with methods for obtaining clinical data such as retrospective studies, small-sample clinical observations, and real-world evidence, prospective registry clinical trials—framed by standardized trial designs, guided by standardized data collection, and ensured by strict quality control throughout the entire process—demonstrate significant advantages in data reliability, accuracy, and consistency.

Research results indicate that,Corheart 6 demonstrates significant efficacy in improving patient survival rates and quality of life, with a low incidence of adverse events that ranks among the international leaders.No adverse events such as pump thrombosis, device malfunction, or hemolysis occurred during the 2-year follow-up period., marking that domestically produced artificial hearts have reached an internationally leading level in long-term reliability, contributing a valuable “Chinese solution” to the global treatment of end-stage heart failure.

Image source: the authoritative journal *European Journal of Cardio-Thoracic Surgery*

This study was led by Fuwai Hospital, Chinese Academy of Medical Sciences, in collaboration with 11 other clinical centers across China. After completing the primary endpoint assessment of the Corheart 6 registration clinical trial, the research team continued to advance long-term follow-up studies. As of September 2024, all participants had completed their two-year post-implantation follow-up, yielding objective and reliable long-term clinical data.

Compared with the inherent limitations of non-registered clinical data, such as incomplete information and selective reporting, thisBased on the Corheart 6 Registration Clinical TrialCohort Study InitiationofLong-termFollow-upClinical Research, by establishing clear and uniform subject selection criteria, implementing standardized end-to-end clinical trial management, and engaging independent third-party Clinical Research Organizations (CROs) for study monitoring, the authenticity, integrity, and traceability of data results are comprehensively safeguarded from source to process.

Among the implantable artificial hearts currently marketed in China, HeartMate 3 and Corheart 6 have disclosed two-year long-term follow-up data based on their respective registered clinical trial cohorts. This further enhances the industry reference value of the research findings for Corheart 6. According to publicly available long-term follow-up clinical data from the registered clinical cohorts,The 2-year survival rates for Corheart 6 and HeartMate 3 were 86% and 76.9%, respectively.The long-term survival data advantages demonstrated by Corheart 6 not only highlight the innovative breakthroughs achieved by domestically produced artificial hearts in technological research and development, but also reinforce Corheart 6’s core competitive barriers in the market, laying a solid foundation for its expansion into both domestic and international markets. Notably,Corheart 6 is the world’s first implantable artificial heart product validated through a long-term study of a registered clinical cohort specifically conducted in the Chinese population., compared with overseas data, its research findings are more aligned with the pathophysiological characteristics and clinical diagnosis and treatment features of Chinese heart failure patients, filling the gap in long-term clinical efficacy data for domestically produced artificial hearts in China.

Source: Compiled from public information (data compared based on long-term follow-up results of registered clinical trial cohorts)

Based on the specific follow-up results, Corheart 6 demonstrates excellent and reliable long-term clinical performance. Among the 50 subjects, 39 (78%) maintained a favorable survival status with device support, 3 (6%) successfully bridged to heart transplantation, and 1 (2%) underwent pump explantation due to significant recovery of cardiac function.

In terms of safety, the Corheart 6 also demonstrates excellent performance.During Follow-up，The systemNo hemolysis, device malfunction, or pump thrombosis occurred.and other adverse events,This “zero-thrombosis” record fully corroborates its internationally leading hemocompatibility. Compared with the 2-year clinical data for HeartMate 3, Corheart 6 LVAS demonstrates certain advantages in hemocompatibility-related adverse events: its 2-year rates of pump thrombosis and ischemic stroke were both 0.0%, whereas the corresponding rates for HeartMate 3 were 1.4% and 5.6%, respectively. These findings provide a reliable clinical basis for its long-term safe use.

Corheart 6 also delivered outstanding results in improving patients’ quality of life. Six months after implantation, all subjects’ cardiac function recovered to NYHA Class I or II, and long-term quality-of-life scores showed a statistically significant improvement from baseline, indicating that patients were able to gradually return to normal daily life.

Industry experts emphasize,Long-term clinical data that strictly adhere to Good Clinical Practice (GCP) and are subject to full-process oversight by independent third-party monitoring bodies possess greater representativeness, objectivity, and comparability, serving as the “gold standard” for evaluating the long-term effectiveness and safety of high-risk medical devices.In contrast, non-registered clinical studies often suffer from limitations such as inconsistent follow-up durations and heterogeneous participant populations, making it difficult to establish a complete and unified chain of long-term follow-up evidence.

Among the four domestically produced implantable artificial heart products currently on the market, there are minor differences in their registration clinical trial designs and primary efficacy endpoints, but significant disparities exist in the number of participating clinical centers and the number of enrolled participants.

It is reported that registration clinical trials for Class III high-risk medical devices typically require data from multi-center studies with large sample sizes. On one hand, conducting multi-center clinical trials can reduce enrollment bias associated with single-center studies, cover diverse clinical scenarios across different regions, populations, and levels of medical care, thereby enhancing the generalizability and extrapolatability of the trial results. On the other hand, within a reasonable range, a larger enrollment size yields higher statistical power, making the trial results more reliable and stable.

The clinical trial design for Corheart 6, which encompasses 12 clinical centers and enrolls 50 patients, is at the forefront among currently marketed domestically produced implantable artificial heart products.

More critically,Corheart 6 achieved 2-year complete follow-up for all subjects, forming a continuous and comprehensive data chain that can more rigorously and accurately reflect the product’s clinical performance during long-term use.Such comprehensive long-term data derived from the registered clinical trial cohort far surpass non-standardized clinical data in terms of representativeness, objectivity, and comparability, further solidifying the reliability of the clinical assessment of Corheart 6 and laying a robust foundation for its approval and promotion in both domestic and international markets.

As one of Core Medical’s flagship products, the Corheart 6 is currently the world’s smallest and lightest commercialized fully magnetically levitated implantable artificial heart, drawing widespread attention from professionals in the global field of heart failure treatment. Furthermore, for pioneering the third-generation fully magnetically levitated artificial heart, Core Medical was awarded the “Important Medical Achievements in China in the 21st Century” by the Chinese Academy of Medical Sciences.

The Corheart 6’s excellent long-term clinical performance is inextricably linked to its proprietary “Time-Shared, Zoned, Dynamic Axial Fully Magnetically Levitated Control Technology.” According to the prospectus,“Time-Sliced, Zone-Differentiated Dynamic Axial Fully Magnetically Levitated Control Technology”By employing multiple sensors to continuously monitor the operating attitude of the impeller and adopting time-division, zone-based electromagnetic multi-point control, a single set of coils synchronously achieves both rotational drive and contactless full-suspension control of the impeller, thereby significantly simplifying the structure of the magnetic levitation motor for artificial hearts.Achieved reduced product size, lower power consumption, and extended battery life, while further optimizing hemocompatibility.

From the perspective of technical implementation, Corheart 6 adopts highly innovativeAxial Fully Magnetically Levitated Motor Structure. Through contactless electromagnetic force control, a reasonable blood flow gap between the impeller and the housing is maintained, thereby reducing the risk of complications such as thrombosis and hemolysis. Compared with traditional radial fully magnetic levitation technology, its motor and impeller center points are aligned on the same vertical line, and the axial levitation position of the impeller is precisely adjusted by electromagnetic force, successfully breaking through the technical bottlenecks of miniaturization and lightweight design in fully magnetically levitated artificial hearts.

Innovations in hemodynamic design are equally indispensable. Leveraging the advantages of the axial magnetic levitation motor structure, Corheart 6 adoptsShort-Distance, Inflection-Point-Free “I”-Shaped Secondary Flow Channel Design, it can thoroughly flush the flow region, significantly reduce flow stagnation zones and vortices, effectively shorten blood residence time, and fundamentally lower the risk of blood damage. In vitro hemolysis test data show that the Corheart 6 has a Normalized Index of Hemolysis (NIH) value of only 0.0013 g/100 L, far superior to the 0.01 g/100 L specified in the ASTM F1841 international standard.

Breakthroughs in core technologies have enabled the Corheart 6 to combine miniaturization, lightweight design, and superior hemocompatibility. For patients, this not only effectively reduces the risk of adverse events such as thrombosis and hemolysis but also supports minimally invasive surgical procedures, resulting in smaller incisions and accelerated postoperative recovery. Meanwhile, it significantly enhances long-term quality of life, helping patients better reintegrate into social life.

These technological innovations have also been recognized by authoritative institutions. Corheart 6 has received the Scientific and Technological Achievement Appraisal from the Chinese Society of Biomedical Engineering, which evaluated it as ““Fills the international gap in ultra-compact, fully magnetically levitated artificial heart medical devices”Notably, Corheart 6 has a broader indication range and has demonstrated unique value in the clinical treatment of pediatric heart failure, making it China’s first implantable artificial heart product approved for clinical use in children with heart failure.

From long-term, reliable clinical validation to independent breakthroughs in core technologies, Corheart 6 is not only a clinical leader in the field of heart failure treatment in China but has also become an innovative benchmark for Chinese-made artificial hearts breaking into global markets. Currently, the product has submitted its CE registration application and launched multicenter clinical trials covering numerous top-tier hospitals across Europe. Meanwhile, it has sequentially obtained marketing approvals in overseas regions such as Colombia and Ukraine, bringing safer and more effective treatment options to end-stage heart failure patients worldwide.