MoyoAssist® Launched! The Mid-to-Short-Term MCS Forum and Extra-VAD Clinical Technology Transformation Results Conference Successfully Held

"The approval of MoyoAssist® marks a further step in aligning our treatment of cardiogenic shock with global standards."

—Prof. Dong Nianguo, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Whether it is the accelerated innovation of various types of ventricular assist devices(VADs) such as long-term, short-to mid-term devices, and interventional devices around the world, or the increasing emphasis on LVAD devices, whose current primary function is assisting the heart's left ventricular ejection, in the treatment of advanced heart failure, this is an indisputable fact that VADs are redefining the treatment landscape of heart failure.

However, when the application scenarios of VADs extend to acute heart failure patients needing ICU, ER, or transport use, there seems to be a lack of suitable VAD equipment. 

The MoyoAssist® fully magnetic levitation external ventricular assist system, jointly developed by Union Hospital of Tongji Medical College of Huazhong University of Science and Technology, and magAssist offers a new paradigm.

On May 25, 2024, the "Mid-to-Short-Term Mechanical Circulatory Support Forum and Extra-VAD Clinical Technology Transformation Results Conference" was successfully held during the 32nd Annual Meeting of the Asian Society of Thoracic and Cardiovascular Surgery. Witnessed by many renowned experts and scholars worldwide, the MoyoAssist® fully magnetic levitation external ventricular assist system (hereinafter referred to as: MoyoAssist® Extra-VAD) was grandly launched, expanding the application scenarios of artificial hearts.

As many experts put at the conference:

MoyoAssist® has unveiled a new chapter in the development of Extra-VAD technology in China!

[Intellectual Gathering in Asia]:
Extra-VAD Clinical Technology Transformation Results Officially Released

From its inception, MoyoAssist® Extra-VAD has embodied the integration of medical science and engineering. Through years of collaborative innovation and joint efforts, magAssist and the team of Prof. Dong Nianguo at Union Hospital of Tongji Medical College of Huazhong University of Science and Technology successfully transformed the device into clinical use in seven domestic hospitals. Prof. Dong's team also pioneered the minimally invasive Extra-VAD placement technique in China.

On April 28, 2024, MoyoAssist® Extra-VAD was officially approved by the NMPA, marking a new chapter in the development of Extra-VAD technology in China. Extra-VAD application has entered a new phase of clinical efficacy validation and technological innovation.

Taking advantage of the 32nd Annual Meeting of the Asian Society of Thoracic and Cardiovascular Surgery, the event set a new course. 

At the release ceremony, Prof. Dong Nianguo of Union Hospital, Prof. Huang Jinsong of Guangdong Provincial People's Hospital, Prof. Ma Ruiyan of the Second Affiliated Hospital of Army Medical University, Prof. Chen Xin of Nanjing First Hospital, Prof. Xi Jicheng of Shanxi Cardiovascular Hospital, Prof. Gong Ming of Anzhen Hospital affiliated with Capital Medical University, Prof. Li Jianming of Xiangya Second Hospital of Central South University, and Prof. Po-Lin Hsu, founder and CEO of magAssist, jointly participated in the Extra-VAD clinical technology transformation results release segment.

With ribbon-cutting, Prof. Dong Nianguo, as the host, delivered a speech in this memorable moment.

Combined with the current development of extracorporeal life support technology in China, Prof. Dong Nanguo said that at this stage, the common clinical applications of IABP and ECMO have their own obvious advantages and disadvantages, and the Extra-VAD technology provides a new addition to the extracorporeal life support for patients with cardiogenic shock and heart failure. As the first extracorporeal VAD with full magnetic levitation technology independently developed by China, the approval of MoyoAssist® Extra-VAD also marks China's further convergence with the world in the treatment of cardiogenic shock and heart failure, and is a major milestone in the development of Extra-VAD technology in China.

Approval is only the starting point, and there is still work to be done in the future. At the end of the speech, Prof. Dong took the opportunity to call on more peers nationwide to join forces:

"In the future, we hope to join hands with more experts to promote the development of China's short-term ventricular assist technology in China to higher, bigger, better, and stronger levels with excellent clinical outcomes and rich technological innovations!"

[Global Perspectives]:
Insights into the Innovation Trends of Mid-to-Short-Term Mechanical Circulatory Support Technology

A new cycle of innovation has begun. Looking at development from a global perspective, today's VADs have made the leap from exploration to iteration. It should not be overlooked that the engine that drives clinical outcomes and technological innovation forward is not only practice, but also communication, which is extensive and in-depth on a worldwide scale.

How do the United States and other countries view the application of VAD?

What are the characteristics of short- and medium-term VAD at home and abroad?

What is the future direction of innovation for fully magnetically levitated external VAD?

Driven by exchange to create a smarter future for Extra-VAD technology, the Mid-to-Short-Term Mechanical Circulatory Support Forum featured prominent experts and scholars from home and abroad, focusing on the clinical application and technological innovation of short-term temporary VADs. Hosted by Prof. Salah Eldie Altarabsheh (Mayo Clinic), Prof. I-Wen Wang (Memorial Healthcare System), Prof. Cheng Zhaoyun (Fuwai Huazhong Cardiovascular Hospital), Prof. Huang Jinsong (Guangdong Provincial People's Hospital), and Prof. Wang Rong (Chinese PLA General Hospital), the forum presented brilliant lectures, showcasing the application status and innovation trends of mid-to-short-term mechanical circulatory support technology from a global perspective.

Jamshid Karimov: Biventricular Mechanically Assisted Circulation as a Transition to Awaiting Heart Transplantation

VAD can provide mechanical circulatory assistance to the left ventricle and right ventricle separately, or BiVAD assistance, which provides circulatory support to the left and right ventricles at the same time, pumping blood to the somatic and pulmonary circulations, and there are different application characteristics of different assist devices. Taking innovative devices from home and abroad as representatives, Prof. Jamshid Karimov from Cleveland Clinic Center, USA, introduced in detail the development status of these three types of assist devices, and focused on the principle and technical characteristics of biventricular mechanical assisted circulation.

Prof. Jamshid Karimov noted that temporary mechanical circulatory support has come a long way in the last 40 years, with significant improvements in utilization and device stability. However, current clinical studies have shown that these devices do not result in higher survival rates when applied to patients with cardiogenic shock. For biventricular mechanically assisted circulation technology, there is still a lack of integrated left and right pump control systems, which at this stage need to be controlled separately by two independent systems. Therefore, future research on cardiogenic shock needs to be strengthened to explore which devices are more suitable for cardiac recovery, leading to lower-cost and more flexible surgical strategies to achieve technological transformation.

I-Wen Wang: Recent Advances in Mid-to-Short-Term Temporary Ventricular Assist Devices

Prof. I-Wen Wang from Memorial Healthcare System Center, USA, gave a comprehensive and detailed presentation on the development trend of short- and medium-term temporary VADs.

He talked about the development of VAD technology since its inception without a clear demarcation between short-term and long-term assistance. In the early days, these devices were mainly designed for short-term supportive care, but with the passage of time and technological advances, as well as the high quality and upgraded performance of VADs, the survival time of many patients has been significantly extended, which in turn has allowed these devices to show the potential for longer-term assistance.

Therefore, according to Prof. I-Wen Wang, timing is key for research on short- and medium-term temporary VADs. With the rapid development of medical technology and the ever-changing needs of patients, the development and upgrading of VADs must keep pace with the times in order to pre-emptively meet the clinical needs that may arise in the future. At the same time, in addition to focusing on the technical aspects of upgrading during the product development process, great attention should be paid to the patient experience. This includes, but is not limited to, the maintenance of mental health, minimization of surgical trauma, and stability of equipment operation. For patients, they not only expect to get effective treatment, but also want to feel comfort and dignity in the treatment process. In addition, the development of surgical techniques is an equally important reference for innovation in ventricular assist.

Dong Nianguo Team: International Expert Consensus on Mid-to-Short-Term VADs

Based on clinical practice, Prof. Dong Nanguo's team interpreted and shared the latest international expert consensus on short- and medium-term VADs, including the core indications for tMCS, the selection of short- and medium-term MCS, the management of the patient during support, and the key points and focuses of device withdrawal.

The consensus firstly introduced that MCS should be considered when needed in patients with advanced heart failure (Stage C, D and IIb to IV classification). tMCS early intervention support is crucial for patients with cardiogenic shock, especially those with acute myocardial infarction combined with cardiogenic shock (AMI-CS) and acute decompensated heart failure with cardiogenic shock (HF-CS).

And for patients in severe cardiogenic shock, the selection of appropriate short- and medium-term MCS support is crucial. Prof. Dong Nanguo's team listed and compared the advantages and disadvantages of IABP, ECMO, axial flow pumps, centrally-intubated centrifugal pumps, and peripherally-intubated centrifugal pumps in detail, and emphasized that when making a specific choice, multiple factors such as the type of heart failure of the patient, traumatic nature, experience of the team, reimbursement, and price should be taken into consideration. Meanwhile, during the period of VAD support, attention should be paid to the prevention and treatment of possible complications, such as infection, bleeding and thrombosis, etc., especially different management strategies should be considered for different types of intubation (central or peripheral intubation); the consensus compares the key points of postoperative monitoring and management that should be focused on for different types of short- and medium-term MCS. When the patient's condition is stabilized and conditions for decannulation are met, a decannulation strategy should be developed based on the patient's specific situation; this may require gradually reducing the intensity of short- and medium-term MCS support and observing the patient's response. During the withdrawal process, emphasis also needs to be placed on assessing organ perfusion and cardiac function; if cardiac function is unstable, withdrawal should be stopped to continue device support.

Li Ping: Clinical Outcome Update of Extracorporeal Ventricular Assist Devices: 40 Cases in China

Focusing on evidence-based, Prof. Ping Li from Union Hospital of Tongji Medical College, Huazhong University of Science and Technology (UHTC) introduced the R&D history of MoyoAssist® Extra-VAD medical-industrial integration and the results of the pre-market clinical study. During the co-development process, Peking Union Medical College Wuhan started from the clinical reality, based on the clinical use scenarios, and put forward the requirements to help optimize the design. After successfully passing the in vitro and animal experiments, the clinical trial led by Wuhan Union Medical College Hospital and jointly conducted by seven hospitals in China was officially launched in June 2021. A total of 40 patients with cardiogenic shock or acute heart failure were enrolled in the trial, of which 50% were PCCS and 32.5% were BTT patients, and also included PCI treatment after AMI-CS, acute infarction combined with ventricular septal defect, right heart failure after LVAD implantation, and left ventricular decompression with ECMO support.

In this cohort of 40 patients, the average duration of support was 8.2 days, and a total of 62.5% of patients met the primary endpoint of the clinical trial, according to the latest study results. During the support period, none of the devices malfunctioned, patients did not experience hemolysis, and hemodynamics remained stable. During the trial, MoyoAssist® Extra-VAD demonstrated excellent blood compatibility and improved the survival of patients with BTT and PCCS. During this period, Wuhan Union Medical College Hospital pioneered the transjugular septal puncture cannulation approach, which allowed patients to be active earlier, improved quality of life, and further improved clinical outcomes. The successful application of this technique has undoubtedly brought good news to patients treated for heart failure.

Tom Logan: The Innovative Path of Fully Magnetically Levitated Extracorporeal VAD

As the chief engineer of MoyoAssist® Extra-VAD, Dr. Tom Logan explained the product's development history and innovative features from an engineering perspective to the experts present. He pointed out that the MoyoAssist® Extra-VAD adopts a multi-dimensional impeller design with Computational Fluid Dynamics-assisted flow channel design, which combines the optimization of more than 10 blade parameters as well as the simultaneous adjustment of the secondary outflow channel and worm shell dimensions to ensure a high flow rate of blood output with a significant reduction in shear stress, thus improving blood compatibility. In addition, the device underwent 100 rounds of laboratory blood testing for material and edge dimensions. By fine-tuning the design parameters, complemented by a spiral worm shell design that smoothly accumulates flow, the device effectively eliminates areas of blood flow separation and stagnation and achieves a more uniform flow distribution, which further enhances the performance and safety of the system.

Notably, for pump control and patient monitoring, the MoyoAssist® Extra-VAD integrates ultrasonic flow transducer and pressure transducer interfaces for precise non-blood flow contact sensing technology. Robust and scalable architectural design ensures system stability and reliability. A robust and reliable power supply and battery system, high performance + high reliability processor architecture, and scalable interfaces and data storage capabilities make the MoyoAssist® Extra-VAD system ready for the challenges of the future.

Chen Shu: Minimally Invasive Surgery for Implantation of Extracorporeal Ventricular Assist Devices

Focusing on the first jugular septal cannulation approach pioneered by Wuhan Peking Union Medical College, Prof. Chen Shu from Peking Union Medical College of Huazhong University of Science and Technology (PUMC) shared the "PUMC" experience. He said that there are three main strategies for Extra-VAD at this stage: central cannulation, small incision cannulation and peripheral cannulation. Peripheral intubation has become an important intubation strategy in clinical practice due to its advantages of less trauma, early discharging of patients and less chance of infection. In the MoyoAssist®Extra-VAD clinical trial, 52.5% of cases were intubated by peripheral means, and the results showed that 71% of patients with peripheral intubation reached the primary endpoint, and the average support time for Extra-VAD was 188.45±120.32 hours, with the longest support time up to 21 days and 12 hours, and the average support flow rate was 2.33±0.47 L/min. end-organ perfusion was significantly enhanced throughout the support period. Notably, no hepatic or renal dysfunction was observed.

In clinical application, Wuhan Union Medical College Hospital has successfully explored the jugular vein through septal cannulation approach and shared the standardized cannulation process at the meeting. This drainage tube combined with axillary artery perfusion tube placement does not affect the patient's lower limb movement, and the patient can get down to the ground as soon as possible, thus promoting the patient's recovery as soon as possible. Prof. Chen Shu also shared the difference between axillary artery perfusion and femoral artery perfusion through CFD simulation and the progress of cannulation at home and abroad.

Wu Min: Management of Right Heart Failure after Heart Transplantation

It is well known that the occurrence of right heart failure is closely related to pulmonary hypertension during heart transplantation. To address this issue, Prof. Wu Min from Guangdong Provincial People's Hospital shared his clinical experience. He said that right heart failure is closely related to pulmonary arterial hypertension in heart transplantation. In addition to the careful preoperative assessment of PAH patients to prevent the risk of right heart failure, the use of RVAD has become one of the most important means of treating right heart failure, bringing hope for life to many patients.

Choosing the most appropriate method of cannulation based on the patient's specific situation and surgical strategy is key to ensuring that the RVAD can accurately and effectively support right heart function. Currently, a variety of intubation techniques have emerged, including central intubation, small incision intubation and peripheral intubation, etc. Each of these techniques has its own advantages and disadvantages, and needs to be selected according to the patient's specific condition and surgical needs. In addition, with the continuous progress of medical technology, the intubation technique of RVAD is also developing and improving, including sternotomy, small incision surgery and percutaneous surgery and other methods, which makes the application of RVAD more extensive and convenient, and RVAD will surely become the key to reduce the risk of right heart failure after cardiac transplantation and improve the survival rate of patients.

After the keynote speech session, Prof. Zhang Shen from Department of Cardiothoracic Surgery, First People's Hospital of Jining City, Prof. Sun Zhanwen from Department of Thoracic Surgery, Huangshi Central Hospital, and Prof. Zhao Di from the Department of Cardiothoracic Surgery, First People's Hospital of Jingzhou City, collaborated with all the participating experts to actively and enthusiastically discuss on the short- and medium-term ventricular assisted clinical techniques.

Innovation is moving forward, and the future is still being created.

From method to concept, from clinic to technology, the continuous iteration of VAD and the enrichment of application scenarios are rewriting the future of heart failure treatment. In this process, MoyoAssist®Extra-VAD, as the first extracorporeal VAD with full magnetic levitation technology in China, has provided a new addition to China's VAD technological innovation, and proved China's research and development strength full of potential in this field.

It is reported that HeartRock Medical is also involved in minimally invasive interventional artificial heart, ECMO, warm-blooded organ transfer platform and other product areas, and is always willing to expand its own exploration results to more organ life support devices, trying to realize the vision of multi-organ life support platform. It is foreseeable that there are infinite possibilities for short- and medium-term mechanical circulatory assistance technology in the current wave of VAD innovation and exploration.

As HeartRock Medical said, "The approval of MoyoAssist®Extra-VAD is just the starting point of HeartRock Medical's commercialization, and HeartRock Medical will continue to plough deeper into the field of life support to develop more really good products for patients in China and even all over the world." We can also look forward to more products like MoyoAssist® Extra-VAD under the favorable ecology of a thousand sails competing for the approval of MoyoAssist® Extra-VAD, and use innovation as a pivot point to drive the "impeller" of the change of China's heart failure diagnosis and treatment at a rapid pace.