China's First Extracorporeal Fully Magnetic Levitation Artificial Heart Completes Clinical Trial Successfully

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The other day,The First Artificial Heart with Magnetic Levitation Produced in China (Extra-VAD) Successfully Completes Clinical Trials.China's Development of Extracorporeal Magnetic Levitation Artificial Heart Achieves Significant Breakthrough, Marking Its Entry into the World's Advanced Ranks in Artificial Heart Technology.The product has the advantages of good safety, high effectiveness, good blood compatibility, and easy transportation.Its successful development can ensure that medical teams have more available and reliable treatment options for heart failure, bringing good news to heart failure patients in China.

According to publicly available data,The MoyoAssist Extra-VAD used in this clinical trial is a multifunctional portable device jointly developed by magAssist and Wuhan Union Hospital. It is suitable for complex scenarios such as ICU and ER, supports patient transport, and provides comprehensive circulatory support for heart failure patients.

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The First Chinese-Made External Magnetic Levitation Artificial Heart

Clinical Trial Completed

Recently, a 48-year-old patient from Xinjiang, Nijiat (pseudonym), with the help of an extracorporeal magnetic levitation artificial heart (Extra-VAD),Successfully passed through an extremely dangerous phase,After 4 days of continuous extracorporeal ventricular assistance, the team led by Professor Dong Nianguo from the Department of Cardiac and Great Vascular Surgery at Union HospitalSuccessfully performed heart transplant surgery.

Nijati (pseudonym) had heart problems early on and underwent mitral valve replacement surgery. He later received ongoing treatment with medication at a local hospital in Xinjiang.But in recent years, Nijati has increasingly felt heart pain with a tendency to worsen,After seeking treatment at a local hospital in Xinjiang, the hospital experts recommended going to Wuhan Union Hospital for treatment. After being seen at Wuhan Union Hospital, the doctors diagnosed Nijat with severe heart failure, and determined that regular medication and surgery could no longer alleviate his symptoms. The only effective treatment option was a heart transplant.However, the patient was elderly and critically ill upon arrival at the hospital, making it extremely difficult to find a suitable heart source in a short period of time.

At this critical moment, Professor Dong Nianguo's team from the Department of Cardiac and Great Vascular Surgery at Wuhan Union Hospital immediately organized a consultation,The final decision was to implant the magAssist Extra-VAD external magnetic levitation artificial heart in this patient.To buy time for a suitable heart. Four days after the patient used this product to assist cardiac circulation, the National Organ Allocation and Sharing Computer System (CORTS) matched a suitable heart.Dong Nianguo's team quickly performed a heart transplant for the patient, who has now had the tracheal tube removed and all vital signs are stable.

What is Extra-VAD?

magAssist's externally magnetically levitated artificial heart acts like a patient’s "second heart." When the patient’s heart can no longer function, the MoyoAssist Extra-VAD, a fully magnetically levitated blood pump designed for short-to-medium-term external ventricular assistance, can be used in cases of heart failure or other high-risk critical conditions requiring temporary support of the heart’s pumping function. These include conditions such as fulminant myocarditis and low cardiac output following heart surgery where patients cannot be weaned off extracorporeal circulation, aiding in their treatment and recovery.

Enterprise-Hospital Joint Research

The extracorporeal maglev artificial heart, jointly innovated and developed by Wuhan Union Hospital and magAssist through nearly five years of arduous exploration, has been successfully translated into clinical use. It is a short-to-medium-term mechanical assist device independently innovated in China with international standards.Wuhan Union Hospital, as the leading unit for clinical trials in China, pioneered a minimally invasive extracorporeal artificial heart implantation procedure, resulting in better patient outcomes.

The extracorporeal maglev artificial heart is for patients with end-stage heart disease,Provided a more suitable treatment for acute heart failure and pre-transplant transitional support tailored to China's national conditions. This also marks that the "Chinese heart," developed through the deep integration of medical research and industry, will offer more "heart" solutions for patients with end-stage heart failure.Bring them new hope for life.

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The Only One in China

Developer of Extracorporeal Maglev Artificial Heart

AsThe Only Company in China Developing Extracorporeal Magnetic Levitation Artificial HeartmagAssist, founded in May 2017, is led by Dr. Po-Lin Hsu, a distinguished expert who was selected for China’s National Talent Program, the first Chinese member of the International Society of Mechanical Circulatory Support (ISMCS), and a specially appointed professor at Soochow University.Co-founded with a top expert team from home and abroad who have been engaged in artificial organ development for a long time, magAssist is committed to building a next-generation extracorporeal life support platform for critical care scenarios.

Academic Research

Since its establishment,magAssist has submitted hundreds of patent applications, covering product pipelines including extracorporeal magnetic levitation artificial heart, interventional artificial heart, ECMO, and organ transport platforms. Among these, over 70% are invention patents, with multiple international patents (PCT) also filed.

June 3, 2022,"Thirty-Day In Vivo Study of a Fully Magnetically Levitated Extracorporeal Ventricular Assist Device" written by Professor Li Ping from the Department of Cardiovascular Surgery at Wuhan Union Hospital was published in the international authoritative journal on artificial organs, Artificial Organs.The article elaborates on how magAssist's fully magnetically levitated external ventricular assist device, MoyoAssist® Extra-VAD, has demonstrated its safety and efficacy through GLP-level animal experimental studies.

The research results show that MoyoAssist® Extra-VADIncluding but not limited to the evaluation of effects on blood, damage to major organs and tissues, and determination of clinically relevant parameters. The prediction of potential adverse events when used in patients with acute heart failure is at an industry-leading level, significantly reducing risks borne by clinical trial participants and clinical users, while providing a basis for the formulation of clinical trial protocols.

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Progressing in Multiple Fields Simultaneously

magAssist (Suzhou) Co., Ltd. has not only made achievements in the field of extracorporeal magnetic levitation artificial heart,At the same time, it has ventured into product areas such as minimally invasive interventional artificial hearts, ECMO, and warm blood organ transport platforms.

Minimally Invasive Interventional Artificial Heart

September 2020,Led by Academician Ge Junbo, the clinical expert team collaborates with magAssist through the integration of medical and engineering expertise, officially launching the interventional ventricular assist device project to tackle the "last mile" of cardiovascular interventional treatment.Jointly develop high-end medical devices produced in China that serve a large number of cardiovascular patients in China and even around the world. The minimally invasive interventional artificial heart, co-developed by Academician Ge Junbo's team and magAssist, is indicated for protection during high-risk PCI procedures.Its key performance indicators are globally leading, with advantages such as smaller invasive size, larger flow, and lower cost.

ECMO

On February 19, 2020, the Suzhou Science and Technology Bureau announced the "List of Emergency Projects for the 2020 Annual Coronavirus Infection Prevention and Control Science and Technology Special Program."magAssist's "Development of Extracorporeal Membrane Oxygenation (ECMO) Products for the Treatment of Critical COVID-19 Pneumonia" Project Approved for Inclusion.Animal experiments were carried out in 2021 to verify various performances of the product and collect opinions and suggestions from the medical team regarding improvements in product structure, performance, operation methods, and other aspects. The animal experiments demonstrated that the system operated smoothly, with performance reaching the same level as international products.This ECMO system is developed based on the third-generation full magnetic levitation system. The current collaborative achievements have reached or surpassed the leading products of the existing second-generation ECMO in the market in major technical indicators such as hemolysis performance, coagulation performance, gas exchange rate, and oxygenator pressure drop.

Warm-Blooded Organ Transport Platform

magAssist has experienced four years of rapid development since its establishment in 2017.Today, magAssist has achieved the fastest R&D progress, the best technology, and the most complete product line in the field of extracorporeal life support devices.The warm-blooded transport platform jointly developed by Wuhan Union Hospital and magAssist successfully completed the first animal heart-less warm-blooded transport in China.There has been another major breakthrough in the frontier field of heart transplantation in China.

magAssist, in collaboration with Wuhan Union Hospital, has developed a warm blood transport platform that is expected to overcome the bottleneck of heart preservation in China.This set of warm blood transport equipment enables the transportation of the heart under aerobic blood supply, significantly reducing cardiac damage and potentially extending preservation time beyond 12 hours.With a longer preservation time, the transportation time and distance can be significantly extended. Even if there are "mountains and seas" between the patient and the donor heart, these "mountains and seas" can all be overcome. In the future, donor hearts from any place in China,Through this warm-blooded transport platform, nationwide coverage in China will no longer be an unattainable dream, and ultimately, more patients with end-stage heart failure will have their lives saved.

What surprises will magAssist bring in the future,Instrument之家 will continue to follow up.