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An interview with Suzhou Tongxin’s Chief CEO Dr. Chen Chen

time:03/22/2018 page views: resource:BioBAY

Heart failure is known as the cancer among heart diseases, and there has been no effective treatment for it. Recently, good news came from Fuwai Hospital in Beijing and Suzhou Tongxin Medical Device Co. Ltd (Suzhou Tongxin), saying the first clinical application of the super-mini artificial heart using magnetic levitation technology has been successful. It is expected to open the new era of heart failure surgical treatment in China. 

Heart failure is the cancer among heart diseases

According to Dr. Chen Chen, in the United States, about 50% of patients who are diagnosed with heart failure will die within 5 years, while about 50% of patients with terminal (NYHAII or IV) heart failure will die within 2 years. Currently, heart transplant is the only known effective treatment for heart failure, but due to extremely limited heart donors, China can only performs about 300 heart transplant operations each year. This is despite the fact that hundreds of thousands of patients are diagnosed with heart failure every year. Heart transplantation cannot therefore satisfy the demands of patients. 

In this case, the emergence of ventricular assist device (VAD) (also known as artificial heart) brings new hope to patients with heart failure. It adopts a mechanical method to temporarily or permanently replace the natural heart to complete blood pumping and promote blood circulation. In an interview with Biodiscover, Dr. Chen noted, “With only physical function and no chemical reaction, heart is the easiest organ to replace with an artificial one compared to other viscera,  the artificial heart is therefore required to perform heart blood-pumping function. What we do is to install the VAD while retaining the patient’s natural heart, and making the two to work together. In other words, VAD performs the work that the original heart is unable to accomplish. 

At present, based on the clinical application results of the artificial heart, the following conclusion can be drawn: first, as a transition of heart transplantation, it helps a patient to live longer as he looks for an appropriate donor; second, it provides short-term support for a patient until his heart resumes normal functioning; Third, it can work together with the original heart to provide prolonged life for the terminal heart failure patient. 

Suzhou Tongxin was founded after Dr, Chen returned to China.

In fact, since 1999, Dr. Chen has been involved in the research and development of the full magnetic levitation artificial heart called Levacor in World Heart Co. Ltd (the world’s second largest artificial heart enterprise) in the United States as a leader. The clinical application of Levacor started in 2006, but it was not accepted in the market because it was too large to be implanted into human thorax. 

Due to the failure of Levacor, the global study on the full magnetic levitation artificial heart suffered a huge setback. After that, only the world’s largest artificial heart enterprise Thoratec continued with the research on the field. Nevertheless, Dr Chen believed that the magnetic levitation artificial heart was the only way to improve blood compatibility among the various products. If we could make breakthrough in its size, the artificial heart would enter into a new step. Therefore, Dr. Chen decided to quit his job in World Heart and went back to China to establish an enterprise engaged in the research of the full magnetic levitation artificial heart. His decision was fully supported by all the Chinese American elites in artificial heart research. At that time, they named their envisaged artificial heart “Chinese Heart” (later renamed CH-VAD). After a series of investigations, in 2018, Dr. Chen founded Tongxin Medical Device Co. Ltd in BioBAY, Suzhou. The Chinese character “Tongxin” not only implies that the company is devoted to the heart-centered research, but also indicates that the Chinese experts, together with all the company employees, have a sincere heart to serve China.

Talking about his experience of winning the SIP Leading Talent of Science and Technology award, Dr. Chen said with a smile, “At that time, I honestly told the juries that it's a fact that all the leading artificial heart enterprises globally think it is impossible to make artificial heart using magnetic levitation technology. To my surprise, I eventually won the award. The vision and courage of the SIP government is admirable, prefiguring the prosperity of our country. In fact, all entrepreneurs in the area are always optimistic. At that time, I didn’t expect that I would take such a long time to complete the research. But I am lucky to establish an enterprise at SIP, and boast a D&R team consisting of experts with seasoned experience in world’s leading artificial heart research, who made right decisions on several key technical routes. In short, they are the ones who have enabled us to achieve success.”

According to Dr. Chen, after the bankruptcy of World Heart, in 2014, Thoratec announced that its super-mini magnetic levitation artificial heart known as HeartMate 3, was undergoing clinical trials in the United States and Europe, showcasing its overwhelming advantage in the research. Since then, Thoratec has been standing out among the world’s artificial heart enterprises. But surprisingly, a Chinese company, Suzhou Tongxin, demonstrated several more advanced technology indexes at an international academic conference, becoming a potential dark-horse in the field. “In terms of the latest generation of the artificial heart, Suzhou Tongxin is the only enterprise capable of competing with Thoratec, the world’s largest artificial heart enterprise,” Dr. Chen proudly said.

Three successfully treated cases with terminal heart failure have been recorded in Fuwai Hospital

It's a fact that VAD can replace the natural heart to complete blood-pumping function, but why is it that there is no large-scale clinical application of VAD yet? Dr. Chen explained that clinical side effects impede its wide application. The side effects are: blood compatibility (gastrointestinal bleeding, cerebral apoplexy and blood pump thrombus), operational aggression (blood pump’ size), infection caused by cable as well as device reliability and durability. The performance of VAD first depends on the supporting mode of the rotor in the blood pump. Up to now, three kinds of modes have been developed: (1) Mechanical contact (mechanical bearing). It is represenby the HeartMate II of Thoratec with the largest sales in the world; (2) Hydrodynamic levitation. It is represented by the HVAD of the HeartWare with the second largest sales in the world; (3) Full magnetic levitation. Compared with the hydrodynamic levitation, it avoids the contradiction between the blood compatibility and the levitation characteristic and provides the possibility to improve the blood compatibility fundamentally.

As shown in the above table, compared with HeartMate 3, CH-VAD boasts obvious advantages in operative aggressiveness, infection risk and device reliability. However, given that the blood compatibility is the most important indicator of artificial heart, the flow field analysis, Hemolysis in Vitro, and animal testing were also conducted to determine which product has better performance. Later, clinical trials with statistical significance for the future will be conducted to confirm which product is more advantageous in blood compatibility. Dr Chen noted that our goal is to make our product, CH-VAD surpass HeartMate 3 in blood compatibility as well as lead in all performances. 

From June to October 2017, under the approval of hospital ethics committee, the academician Hu Shengshou from Fuwai Hospital, together with his team, applied this super-mini full magnetic levitation artificial heart for humanitarian reasons to treat three patients with terminal heart failure, and to their surprise it was very successful.  

At present, through the help of the artificial heart, the first patient has been living a normal life for more than eight months. The second patients has successfully received a heart transplant operation after using the artificial heart for 192 days, The third patients used the artificial heart for more than five months, and with the recovery of his original heart functioning, the artificial heart is expected to be removed. The good clinical results demonstrate that our country has achieved leapfrog development in the artificial heart and is emerging as one of the international advanced countries in the field. 

A new era on heart failure treatment is opening up 

With the price of a set of artificial heart product in the US reaching basically $100,000, artificial heart is considered as the most expensive disposable medical device. Therefore, as an enterprise devoted to serving the world, Suzhou Tongxin is thinking about how to better serve the Chinese people. 

Dr. Chen said, “The demand for low-priced artificial heart is global. We hope to continuously reduce the price of the artificial heart through technological innovation. In addition, we will avoid the subsequent medical cost caused by adverse reactions of artificial heart, with an aim to reduce the overall cost of treatment. More importantly, we will fully reflect the idea of serving the people in the clinical application of the artificial heart, so that our domestic patients can enjoy the same medical technology and medical services as the developed countries.” Dr. Chen noted, as the “National 1000 Talents Program” special expert, he will shoulder the pioneering entrustment of the Chinese-American expert team. Suzhou Tongxin will ensure that China keeps up with the developed countries in the field, providing the most considerable and advanced medical services for the Chinese patients.

Source: Biodiscover