CoreMed's Corheart 6 Achieves World-Leading 2-Year Survival Rate of 86%, Landmark Clinical Study Published in European Journal of Cardio-Thoracic Surgery

This is the first long-term follow-up clinical study on the registration clinical cohort for an artificial heart produced in China., systematically analyzed and confirmed that independently developed in ChinaThe Long-term Clinical Value of Corheart 6 Fully Magnetically Levitated Implantable Left Ventricular Assist System. Industry experts point out that compared with retrospective studies, small-sample clinical observations, and real-world clinical data acquisition methods, prospective registration clinical trials—based on standardized trial design, regulated data collection, and strict quality control throughout the process—offer significant advantages in terms of data reliability, accuracy, and consistency.

The research results show that,Corheart 6 shows significant effectiveness in improving patient survival rates and enhancing quality of life, with a low incidence of adverse events at an internationally leading level. No adverse events such as pump thrombosis, device failure, or hemolysis occurred during the two-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.

Source of the image: authoritative journal "European Journal of Cardio-Thoracic Surgery"

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

Compared with the inherent defects of non-registered clinical data, such as information incompleteness and selective reporting, this time based onThe long-term follow-up clinical study of the Corheart 6 registration clinical cohort ensured the authenticity, integrity, and traceability of the data results from the source to the process by establishing clear and unified subject screening criteria, standardized full-process clinical management, and introducing an independent third-party clinical research site management organization to participate in study monitoring.

Among the currently marketed implantable artificial hearts in China, there areHeartMate 3 and Corheart 6 Disclose 2-Year Long-Term Follow-Up Data Based on Registered Clinical Trial Cohorts. This also makes the research results of Corheart 6 more valuable as an industry reference. Long-term follow-up clinical data from the publicly registered clinical cohort shows,The 2-year survival rates of Corheart6 and HeartMate 3 are 86% and 76.9%, respectively.The long-term survival data advantage demonstrated by Corheart 6 not only highlights the innovative breakthroughs in the research and development of artificial hearts produced in China, but also strengthens Corheart 6's core competitive barrier in the market, laying a solid foundation for its expansion in both domestic and international markets. Notably,Corheart 6 is the world's first implantable artificial heart product validated by long-term research in a registered clinical cohort study conducted specifically for the Chinese population.Compared with overseas data, its research results are more in line 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 of the chart: Collation of public information (Data comparison based on long-term follow-up results of registered clinical trial cohorts)

From the specific follow-up results,Corheart 6 Demonstrates Excellent and Reliable Long-Term Clinical Performance. Among 50 subjects, 39 (78%) maintained good survival status with device assistance, 3 (6%) successfully transitioned to heart transplantation, and 1 (2%) underwent pump removal surgery due to significant cardiac function recovery.

In terms of safety,Corheart 6 also performs exceptionally well.During the follow-up period, the system did not experience any adverse events such as hemolysis, device malfunction, or pump thrombosis.This "zero thrombosis" record fully demonstrates its internationally leading blood compatibility. Compared with the 2-year clinical data of HeartMate 3 after implantation, Corheart 6 LVAS shows certain advantages in blood compatibility-related adverse events: its two-year pump thrombosis rate and ischemic stroke rate are both 0.0%, while the corresponding figures for HeartMate 3 are 1.4% and 5.6%, respectively. This result provides reliable clinical evidence for its long-term safe application.

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

Industry experts emphasized,Such long-term clinical data, which strictly adheres to Good Clinical Practice (GCP) and is fully supervised by third-party independent monitoring agencies, possesses stronger representativeness, objectivity, and comparability, serving as an essential basis for evaluating the long-term efficacy and safety of high-risk medical devices."Gold Standard"In contrast, non-registered clinical studies often have shortcomings such as inconsistent follow-up durations and mixed subject groups, making it difficult to form a complete and unified long-term follow-up evidence chain.

Currently MarketedFour domestically produced implantable artificial heart products show little difference in the design of their pivotal clinical trials and primary efficacy endpoints, but there are notable distinctions in the number of clinical centers involved and the number of patients enrolled in the trials.

It is reported that the registration clinical trials for three categories of high-risk medical devices often must include research data from multi-center and large sample size studies. On one hand, conducting clinical trials across multiple centers can reduce single-center enrollment bias, covering clinical scenarios involving different regions, populations, and levels of medical care, making the clinical trial results more generalizable and extrapolative. On the other hand, within a reasonable range, the larger the number of trial participants, the higher the statistical power, and the more reliable and stable the trial results.

The clinical trial design of Corheart 6 covers a study scale of 12 clinical centers and 50 enrolled patients, which is at a leading level among currently marketed domestically produced implantable artificial heart products in China.

More crucially,Corheart 6 has achieved a complete 2-year follow-up for all subjects, forming a continuous and complete data chain, which can more rigorously and truthfully reflect the clinical performance of the product during long-term use.This complete long-term data based on registered clinical trial cohorts is far more representative, objective, and comparable than non-standardized clinical data. It further strengthens the reliability of Corheart 6's clinical evaluation and lays a solid foundation for its approval and promotion in both domestic and international markets.

Corheart 6, one of Core Medical's flagship products, is currently the world's smallest and lightest commercialized fully magnetically levitated implantable artificial heart, widely recognized by professionals in the global heart failure treatment field. Core Medical was also awarded the "Important Medical Achievement of China in the 21st Century" by the Chinese Academy of Medical Sciences for developing the third-generation fully magnetically levitated artificial heart.

The excellent long-term clinical performance of Corheart 6 is inseparable from its original "Time-Partition Dynamic Axial Full Magnetic Suspension Control Technology." According to the prospectus,"Time-Division and Zoning Dynamic Axial Full Magnetic Suspension Control Technology"By utilizing multiple sensors to constantly monitor the operating posture of the impeller and adopting time-sharing and zone-based electromagnetic multi-point control of the impeller, it is possible to synchronously achieve rotational drive and non-contact full suspension control of the impeller with just one set of coils. This significantly simplifies the structure of the magnetic levitation motor in artificial hearts.Achieve smaller product size, lower power consumption, longer battery life, and further optimize blood compatibility.

From the perspective of technical implementation path,Corheart 6 adopts highly innovativeAxial Full Magnetic Suspension Motor StructureThrough contactless electromagnetic force control, it ensures a reasonable blood flow gap between the impeller and the shell, thereby reducing the risk of complications such as thrombosis and hemolysis. Compared with traditional radial full magnetic levitation technology, its motor and impeller center points are on the same vertical line, and the axial suspension position of the impeller is precisely adjusted through electromagnetic force, successfully breaking through the technical bottleneck of miniaturization and lightweight of full magnetic levitation artificial hearts.

Innovation in hemodynamic design is equally indispensable. Relying on the advantages of axial magnetic suspension motor structure,Corheart 6 adoptsShort-distance, no-inflection "I"-shaped secondary flow channel design, which can fully flush the flow area, significantly reduce flow stagnation zones and vortices, effectively shorten blood retention time, and fundamentally reduce the risk of blood damage. In vitro hemolysis test data shows that the Corheart 6 hemolysis index NIH value is only 0.0013g/100L, far superior to the ASTM-F1841 international standard of 0.01g/100L.

Breakthroughs in Core TechnologyCorheart 6 combines the advantages of miniaturization, lightweight design, and excellent blood compatibility. For patients, it not only effectively reduces the risk of adverse events such as thrombosis and hemolysis but also supports minimally invasive procedures to reduce surgical incisions and accelerate postoperative recovery, while significantly improving long-term quality of life, helping patients better reintegrate into social life.

These technological innovations have also been recognized by authoritative institutions.Corheart 6 Receives Scientific and Technological Achievement Appraisal from the Chinese Society of Biomedical Engineering, and is Evaluated"Fills the gap in the international ultra-small fully magnetic suspension artificial heart medical device field"Notably, Corheart 6 has a broader range of applicable patients and has demonstrated unique value in the clinical treatment of pediatric heart failure. It is China's first implantable artificial heart product for pediatric heart failure clinical use.

From long-term clinical validation to breakthroughs in core technology,Corheart 6 is not only a leading clinical solution in China's heart failure treatment field, but also an innovative benchmark breaking new ground for domestically produced artificial hearts in overseas markets. Currently, the product has submitted a CE registration application and initiated multi-center clinical trials covering several top-tier hospitals across Europe. Meanwhile, it has successively obtained market approval in overseas regions such as Colombia and Ukraine, offering safer and more effective treatment options to patients with end-stage heart failure worldwide.

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