# Three Types of 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 for 3 months; patients surviving with the device for 3 months meet the standard.。
Corheart 6 (Core Medical)
▲Corheart 6Fully Magnetically Levitated Centrifugal Left Ventricular Assist System（SourceOfficial CompanyNet)
Corheart 6 by Core Medical isThe World's Smallest, Lightest, and Longest Battery LifeThe brand-new generation of fully magnetically levitated centrifugal left ventricular assist system. As of now, Corheart 6 has achieved many industry breakthroughs: implanted in more than 120 patients, creatingImplantation Volume Ranks First in China、Achieve the most clinical applications in China; Complete clinical enrollment in 159 days, breaking the industry's clinical speed record.
It is reported that the diameter of the Corheart 6 blood pump is 34mm and the thickness is 26mm.Weight is only 90 grams. In terms of blood pump technology, this product adopts the third-generation non-contact magnetic suspension centrifugal pump, and its core technology mainly includesDisc Motor Technology, which uses position sensors to detect and control the rotor's speed and suspension height. The product's motor only employs a single set of stator coils to simultaneously control the rotor's rotation and suspension.Simpler structure, lighter weight, smaller size, lower power consumption,In clinical applications,The surgical incision is smaller, patients recover faster, and it is suitable for a wider range of people., and canReduce the Risk of Thrombosis Caused by Blood Pump Heat。
At the same time, the range of suitable users for the product has been further expanded.Can be applied to children and overweight populationsHigh-risk patient groups such as... In addition, the advantage of Corheart 6 being lightweight can...Reduce gravitational traction on the myocardium, reduce mechanical interference on myocardial reverse remodeling, and are more conducive to cardiac recovery treatment.
Compared with similar international products, the key performance indicators of Corheart® 6 have reached the same level, and it has set several records both in and outside China, significantly enhancing the competitiveness of domestically produced artificial hearts in the international market.
HeartCon (Tianjin Heart)
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), and 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 CompanyNetwork)
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 thrombosisFeatures.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 (Concentric Medical)
Concentric 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, CH Biomedical 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 Part and External PartComposition,The core component, the blood pump, is a special and precise centrifugal pump small enough to be held in the palm of one's hand., its impeller is supported by magnetic suspension bearings and rotates driven by a brushless DC motor. The external controller completes power management, blood pump status monitoring and adjustment, 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.
# Heart Failure Treatment Market
Heart failure, the end-stage of heart disease progression, has a five-year mortality rate as high as 30-70%, and is widely recognized as "the last battlefield in the field of cardiovascular disease."According to public data, there are nearly 30 million heart failure patients globally.China has approximately 10.67 million heart failure patients.. It is expected that with the extension of survival period of patients with heart disease and the deepening of aging,The Number of Heart Failure Patients Will Continue to Grow。
Data released by market research firm ReportLinker shows：The global heart failure treatment device market is expected to reach 14 billion US dollars by 2025.The Market Size of Heart Failure Management in China Will Exceed 10 Billion。The population suffering from heart failure in China accounts for 1.3% of the total population, with approximately 13.7 million heart failure patients. Among these patients, 5% progress to advanced heart failure each year, or 685,000 people. For advanced heart failure, the commonly used treatment methods currently include medication, heart transplantation, and mechanical circulatory support, butThe effect of drug treatment is poor, and the drug treatment for severe heart failure patientsThe 6-month mortality rate is as high as 60%-80%, and the 1-year survival rate is only 25%.。
At the same time,Heart TransplantAs an effective treatment for end-stage heart failure currentlyConstrained by factors such as the number of donors, donor matching conditions, and the high difficulty of surgery., The current annual average volume of transplant surgeries in ChinaOnly about 600 cases(564 units in 2020).The implantable ventricular assist system mainly treats end-stage heart failure by partially or completely replacing the natural blood supply to the human body through mechanical or biomechanical means.Data shows that since Fuwai Hospital pioneered the Chinese-made implantable LVAD surgery in 2017, up to March 2023, 82 implantable left ventricular assist device implantation surgeries have been completed, including three types of ventricular assist devices: Chongqing EVAHEART I, Suzhou CH-VAD, and Shenzhen Corheart6.During the same period, a total of 363 implantable ventricular assist devices were applied in 70 hospitals across China. Moreover, by October of the same year,A total of more than 500 implants have been completed in 85 hospitals across China.. Nationwide, 16 hospitals have implanted more than 10 cases, 8 hospitals have implanted 6-9 cases, and 61 hospitals have implanted 1-5 cases, mainly concentrated in hospitals in the central and eastern regions of China.Although China's artificial heart industry is still in its infancy, besides a few companies with approved products, other enterprises such as XinCheng Medical, JiuAn Artificial Heart, TongLing Bioengineering, XinLing MaiDe, FengKaiLi Medical, XinHengRui, DiYuan Medical, and XinLing MaiDe have also begun to establish their presence in this field.Among them,NyokAssist, the minimally invasive interventional artificial heart developed by HeartPower Medical, was approved as an innovative medical device on February 4, 2024, and has entered the special review channel.. It is reported that the product has successively obtained the U.S. FDA "Breakthrough Device" designation and the innovative medical device approval from the National Medical Products Administration within half a year, becomingThe world's only interventional artificial heart to simultaneously achieve "innovation approval in both China and the U.S.", is another important milestone for domestically produced high-end medical devices.According to data from the U.S. Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs),More than 80% of artificial hearts in the United States are used for long-term assistance.Long-term assistance means that after the artificial heart is implanted, the patient can use it for a lifetime without undergoing another surgery for a heart transplant.Therefore, for end-stage heart failure patients in China,Long-term assistive artificial hearts are currently the best solution for treating heart failure.。Details of 5 China-made implantable artificial hearts approved:
August 2019,EVAHEART Implantable Left Ventricular Assist System by EVAHEART MedicalApproved for marketing. The product isFirst Official LaunchChinese-made Implantable Left Ventricular Assist System, using a centrifugal mechanical bearing structure.November 2021,CH-VAD Implantable Left Ventricular Assist System by Suzhou Tongxin MedicalApproved for marketing. This product adopts the latest generation of magnetic levitation technology, which isFirst Official LaunchTheMade in ChinaMagnetic Levitation Artificial Heart, breaking Abbott's monopoly.July 2022,Under the EVAHEART brandHeartConImplantable Left Ventricular Assist SystemApproved for marketing, isThe First in ChinaAdoptMagnetic Liquid Suspension TechnologyImplantable artificial heart.June 2023,Corheart®6 Implantable Left Ventricular Assist System by Core MedicalApproved for marketing,Is currentlyThe Smallest and Lightest in the WorldArtificial Heart.February 2024,EVAHEART's EVA-Pulsar™ Left Ventricular Assist Device Officially Receives NMPA Medical Device Registration Certificate, Becoming the Second Long-Term Artificial Heart to be Marketed in China.
# Prospects for the Promotion of Artificial HeartsIn the context of heart failure treatment, in addition to issues such as the education of patients and doctors about artificial hearts, and patients' concerns about life after implantation, compared to developed countries where artificial hearts are mostly covered by commercial insurance,The Current Situation in China: Domestic Health Insurance and Commercial Insurance Have Not Yet Covered Artificial HeartsEven moreBecoming the Most Realistic Problem in the Market Promotion of Artificial Hearts。Director of EVAHEART MedicalYan Huastated that patients will receive treatments including medication during the progression of heart failure.ICD(Implantable Cardioverter Defibrillator), CRT (Cardiac Resynchronization Therapy), and other treatments have already imposed a heavy financial burden on families. "Some patients with acute heart failure may require ICU monitoring and treatment, using ECMO (Extracorporeal Membrane Oxygenation) for cardiopulmonary support. If the duration of support is relatively long,It also costs more than 200,000 yuan.. Therefore, when patients reach the late stage of heart failure, they needDuring the artificial heart implantation,Other expenses will also exceed five or six hundred thousand.. Not to mention proceeding with the next stepsFull Self-Pay Artificial Heart Implantation。”Lack of understanding + full self-payment keeps artificial hearts in China still at the difficult uphill stage of early education., thereforeIt is necessary to solve patients' payment ability through various forces before the widespread implementation of medical insurance., insurance is a very good way.According to Yan Hua, EVAHEART will go throughHealth Insurance + Commercial Insurance + Charity`, a set of combination punches,`Enable patients to use it before medical insurance reimbursement.，even after national health insurance is able to reimburse, as a good supplement to health insurance.The strong clinical demand for artificial hearts goes without saying, but the market volume and scale that can support such demand are also indispensable. Under the influx of top-tier capital,Whether this track can open up more domestic markets in China through technological innovation may be more meaningful than which company can take the lead.。Perhaps as Yan Hua said,Only with more players joining can education be popularized and the market expanded together.Under the vision of saving lives and healing the wounded, artificial hearts still need a better commercial answer.# EVAHEART
EVAHEARTEstablished in June 2014, mainly engaged in the research and development, production, and sales of high-end medical devices — the implantable left ventricular assist device EVAHEART (artificial heart).
This product is the result of over 50 years of fundamental research and more than 20 years of collaborative design and development by prestigious institutions such as Waseda University, Tokyo Women's Medical University, the National Institute of Advanced Industrial Science and Technology, and Japan Sun Medical Technology Research Institute.EVAHEARTThrough the full set of technology introduction, promote and implement localization in China.，Becoming the company in China currently approved for both short-term and long-term treatment dual indications artificial heart research, manufacturing, and sales.。
▲EVAHEART Left Ventricular Assist Device
As of now,EVAHEART Left Ventricular Assist Device Has Broken Multiple Industry Records in China：● Officially Certified Earliest: The first artificial heart product approved by the China Food and Drug Administration, with a 1-year clinical trial survival rate of 100%;● Full Range of Indications: An artificial heart approved by the FDA for both short-term and long-term treatment indications;● The Fastest Globalization Process: Approved for marketing in Europe and Japan, and also received IDE approval from the United States. It is the only Chinese artificial heart being used overseas.● Longest Implantation Duration: The first implant recipient has been assisted for over 11 years.March 2023,EVAHEART CompletesNearly 100 Million USD in Series A FinancingLed by Sinovac Biotech Co., Ltd., with follow-up investments from Taiping (Shenzhen) Medical and Health Industry Private Equity Investment Fund Partnership (Limited Partnership), and additional investment from existing shareholder Vivo Capital.This round of financing will enable EVAHEARTFurther Construct and Develop a Severe Heart Failure Treatment and Health Industry Platform。
As of the date of this report, the company's financing history is as follows:
# Global Leading Cardiovascular Device CompanyMedtronic｜J&J MedTech|Boston ScientificBoston Scientific|
Edwards Lifesciences | AbbottAbbott｜
# Cardiovascular Device Companies Listed in China
# Innovative Devices Approved in China in 2023#2023 Medical Devices Entering China's Innovation ChannelXinQing Medical (NyokAssist Interventional Ventricular Assist System)
Beixin Life (Cardiac Pulse Field Ablation)
Hanling Medical (Transcatheter Aortic Valve)
# Other Unlisted/Start-up Cardiovascular Companies
Artivion| HVR Cardio | CardiacSense | Lydus Medical | Volta Medical |Cardiac Dimensions
