CoreMedtech's Corheart®6, the World’s Smallest Artificial Heart, Completes First-Ever European Implantation

Nov 07, 2024 08:57 CST Updated 08:57

Core Medical

Artificial Heart Series Product Developer

Source of the article: HeartFuture；Editor: Bai Xiaofei

Reprint Requirements: If the source of the article is indicated at the beginning of the text, it can be reprinted directly.

Heart Future

Recently,Shenzhen Core Medical Technology Co., Ltd(abbreviation "Core Medical") independently developed byImplantable Left Ventricular Assist Device (LVAD) Corheart®6，Successfully Completed in EuropeFirst CaseClinical Trial Enrollment, this isFirst European Clinical Trial of LVAD Independently Developed in China, This successful implantation marks an important step for China's self-developed artificial heart in global application.

Corheart®6 is independently developed by Core Medical.Implantable Full Magnetic Levitation Artificial Heart, used forProvide Hemodynamic Support for Patients with Advanced Refractory Left Heart FailureWith a blood pump diameter of only 34 millimeters, thickness of 26 millimeters, and weight of approximately 90 grams,40% smaller in diameter and 50% lighter in weight compared to similar products on the market., according to the company, is currentlyThe World's Smallest and Lightest Artificial Heart。

In June 2023, the National Medical Products Administration approved the registration application for the innovative product, an implantable left ventricular assist system (trade name: Corheart®6) produced by Core Medical.The Fourth Implantable Left Ventricular Assist System in China(Short-term LVAD), the previous three products are respectivelyEternal Heart(Long-term LVAD),Concentric Medical(Short-term LVAD),Aerospace Taixin(Short-term LVAD)。

▲European Experts Conduct Preoperative Training for Corheart®6

In 2024, Core Medical collaborates with numerous top medical centers in Europe to launchA prospective, single-arm, multi-center study covering multiple hospitals across several European countries was conducted toEvaluation of the Safety and Efficacy of Corheart®6 in Providing End-Stage Heart Failure Treatment Solutions for Doctors and Patients Worldwide。

The first surgery of Corheart®6 European Clinical Trial was performed byCharité – Berlin University of Medicine(Charité) Professor Evgenij Potapov joined handsVienna General Hospital(Vienna General Hospital) Professor Daniel Zimpferi and Professor Julia Riebandt jointly completed.

Charité – Berlin University of Medicine is the largest university-affiliated teaching hospital in Europe. Professor Daniel Zimpfer of Vienna General Hospital is a world-leading expert in cardiothoracic surgery, has long served as a scientific advisor for multiple ventricular assist devices, and is the principal investigator for several internationally renowned studies. He also serves as a long-term reviewer for many authoritative international medical journals.The first clinical surgery was successfully performed at Charité – Universitätsmedizin Berlin.Demonstrates Core Medical's high confidence in its products and also shows the full trust of the European academic community in Corheart®6.。

# Postoperative Evaluation

InEvgenij Potapov The entire surgical team represented by ProfessorClinical Performance of Corheart®6 Left Ventricular Assist SystemHas been given high recognition and affirmation., the ICU team was amazed by the low power consumption of this product, and the significantly lightweight external deviceThe preparation will greatly improve the quality of life for patients. The VAD management team also stated that the Corheart®6 software functionality is comprehensive and practical, ensuring...While ensuring patient safety, it also facilitates doctors' management of patients.

▲Corheart®6: All Parameters Operating Smoothly

Prior to this,Corheart®6 once set a new speed record in China's industry, completing all clinical enrollments in 159 days.，In terms of the reliability of the device,Excellent performance in blood compatibility, infection risk prevention and control, etc.. Some analyses pointed out that the implementation of this clinical surgery is not only expected to end China's long-term reliance on imported active implantable therapeutic devices, filling the industry's export gap, but also bring advanced "Chinese hearts" to heart failure patients in Europe and a broader global audience.

# Corheart® 6 Implantable Left Ventricular Assist Device

Corheart®6Composed of implanted components, external components, and surgical accessories, used in conjunction with specific artificial blood vessels to provide mechanical support for blood circulation in patients with advanced refractory left heart failure.Used for transitional treatment before heart transplantation or to restore heart function。Product isThe Third Generation Non-Contact Magnetic Levitation Centrifugal Pump, The core technology is mainly disk motor technology, which uses position sensors to detect and control the rotor's speed and suspension height.

The motor uses only one set of stator coils to control both the rotation and suspension of the rotor.Simpler structure, lighter weight, smaller size, lower power consumptionIn clinical applications, the surgical incision is smaller, patients recover more quickly, it is suitable for a wider population, and can reduce the risk of thrombosis caused by blood pump heat.

According to the company, as a representative of the new generation of miniaturized fully magnetically levitated artificial hearts, Corheart® 6Through excellent structural design and motor design`, conquered`Long-term use of artificial hearts may lead to thrombosis and bleeding.Difficult problem,Effectively ensured the survival rate of patients and significantly improved their quality of life after surgery.。

RelevantTest toAnd clinical data show,Corheart®6 Implantable Left Ventricular Assist Device Excels in Infection Risk Control, Device Reliability, and Hemocompatibility, reaching an internationally leading level.

Corheart® 6 Clinical Study on Cardiac Function Improvement

Compared with traditional artificial hearts,Miniaturized artificial hearts offer greater advantages for surgical implantation in patients.: Small size, light weight, less invasive in clinical surgery, suitable for a wider population, and more beneficial for the recovery of patients' cardiac function. With such advantages,Corheart®6 also fills the gap inThe Blank of Artificial Heart Implantation in Chinese Children.

In June 2022, the team of Academician Shengshou Hu from Fuwai Hospital, Chinese Academy of Medical Sciences,Successfully implanted Corheart®6 into a 14-year-old child with end-stage heart failure., marking a significant leap in the clinical application of left ventricular assist devices for children in China. According to the company, with just 100 days of support from Corheart®6 and the scientific care provided by the medical team, the child's heart function recovered to a normal state. The device was eventually removed, truly achieving the reversal of heart failure treatment.

February 2023, Binjiang Campus of Zhejiang University Children's HospitalSuccessfully implanted Corheart®6 in a 12-year-old child with end-stage heart failure weighing only 30.2 kilograms., once again刷新了中国人工心脏植入手术最小年龄、最低体重记录。据介绍，经过术后2个月时间的康复，患儿目前已能过上接近正常人的生活，心功能已恢复到Ⅱ级水平。该临床应用也再次验证了Core Medical's Corheart® 6 artificial heart can be safely used in populations with smaller BSA (Body Surface Area).。

# The Other Two Short-Term Artificial Hearts

Short-term artificial heart is only approved for short-term transitional treatment. According to the technical review report on the website of the Center for Medical Device Evaluation of the National Medical Products Administration, the short-term transition refers to...Implantable Left Ventricular Assist System (Left Ventricular Assist Device, LVAD)Product OnlyEvaluate the clinical safety and effectiveness over 3 months; patients surviving with the device for 3 months meet the criteria.。

HeartCon (Tianjin HeartCon Medical Technology Co., Ltd.)

HeartCon, also known as the "Rocket Heart," was jointly developed by the China Academy of Launch Vehicle Technology and Tianjin TEDA International Cardiovascular Hospital (hereinafter referred to as TEDA Hospital). It is a domestically produced artificial heart in China.Implantable Left Ventricular Assist System with Full Independent Intellectual Property Rights。

▲HeartCon ImplantableLeft Ventricular Assist System（SourceOfficial CompanyNet)

In 2013, the experimental sheep "Tianjiu" survived healthily for 120 days, setting five firsts including the longest survival record in China; in 2018, the product passed the special approval for innovative medical devices. In July 2022, HeartCon received approval from the National Medical Products Administration for short-term assistance, becomingThe Second Self-Developed Ventricular Assist Device Approved in China。

HeartCon belongs to the current third-generation implantable magnetic-liquid suspension ventricular assist device, which adoptsMagnetic and Fluid Dual Suspension, Pump-Motor Integration, System Dual Redundancy Technical Solution, withSmall size, light weight, low hemolysis, minimal thrombosisCharacteristics.

In addition, the second-generation implantable artificial heart developed by the company——HeartConⅡ, forThe World's FirstThe Third-Generation Fully Magnetically Levitated Blood Pump with No Active Magnetic Bearings and Position Sensors, Lightest Weight, and Smallest Size, which is currently undergoing registration inspection and animal experiments, with clinical trials expected to commence in 2024.

CH-VAD (Core Medical)

Core Medical adopts the new generation of magnetic levitation technology. Its CH-VAD implantable left ventricular assist system was approved for marketing by the National Medical Products Administration in November 2021, becomingChinaThe FirstFully Magnetically Levitated Artificial Heart Officially Launched，Broke Abbott's MonopolyAt the same time, with the latest breakthroughs in key performance indicators such as blood compatibility, implant invasiveness, and infection prevention, Core Medical has gained an international reputation as a technological pioneer, continuously demonstrating its strength as a global technology and market leader.

▲CH-VADImplantableLeft Ventricular Assist System（SourceOfficial CompanyNet)

CH-VAD is mainly composed ofImplantable and External PartsComposition,The core component, the blood pump, is a special and precise centrifugal pump that can be held in the palm of one's hand., its impeller is supported by magnetic suspension bearings and rotates under the drive of a brushless DC motor. The external controller manages power supply, monitors and adjusts the status of the blood pump, and provides a user interface. The entire systemIntegration of Software and Hardware, which must meet extremely high requirements for reliability, medical device safety, and electromagnetic compatibility.

# Company Profile

Shenzhen Core Medical Technology Co., Ltd. (hereinafter referred to as "Core Medical") was established in August 2016, with its headquarters located in Shenzhen.Focus on high-end innovative medical device products such as mechanical circulatory assist devices (commonly known as "artificial hearts")Research and Development and Production,Achieved a comprehensive layout in the field of implantable and interventional artificial hearts., committed to providing a comprehensive solution for heart failure patients worldwide.

In the miniaturization of artificial heartsThe key performance indicators of Corheart® 6, a super-compact fully magnetically levitated artificial heart independently developed by Core Medical, have reached the same level as international counterparts, significantly enhancing the competitiveness of Chinese-produced artificial hearts in the global market.

In product lines such as the interventional artificial heart CorVadCore Medical has also carried out innovative R&D, achieving high flow with a smaller interventional size. Its self-designed micro motor and control technology have further reduced the risk of hemolysis, enhancing product stability and long-term operational reliability.

Since 2019, Core Medical's innovative achievements in the artificial heart field have been highly favored by the capital market.Completed 5 rounds of financing in five years, with a steady development momentum。

Query the company's financing history as follows:

# The Entrepreneurial Story of a STEM Whiz

Dr. Yu Shunzhou, founder of Core Medical, graduated from Harbin Institute of Technology.After obtaining his Ph.D. from Harbin Institute of Technology, Yu Shunzhou furthered his studies in mechanical engineering at the University of California, Davis.In 2011, by a chance opportunity,He ventured into the artificial heart field., began working as a senior engineer at a top artificial heart company in the United States,And participated in the development of multiple artificial heart products, including Heartmate 3.——The world's most advanced left ventricular assist device product.

In 2016, Medtronic's acquisition of HeartWare, the second-ranked company in the artificial heart field for $1.1 billion, caused a sensation. At that time, the prevalence of cardiovascular diseases in China continued to rise, while the supply of heart transplant donors was extremely scarce, and heart failure was also known as the "last battlefield" in the cardiovascular field. Witnessing all this, Yu Shunzhou decided to return to China to start a business, and Core Medical was born.

Seemingly a natural and effortless decision, but behind it lies a little-known detail:Yu Shunzhou's mother is also a heart failure patient.. He once frankly said when talking about entrepreneurship: "I also have a heart failure patient in my family, so I deeply understand the desire of heart failure patients for life and quality of life."

In 2016, Yu Shunzhou returned to China and founded Core Medical, settling in Zhin Park, Nanshan, Shenzhen.

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