From Bridge to Full Replacement: SynCardia, the Leader in Total Artificial Hearts, Spans 40 Years of Self-Disruption and the China Story

"If you open up the heart, you'll find that the thickness of the left side is 2 to 3 times that of the right. This isn't a design flaw; it's a physiological rule — the thicker muscle is there to pump blood to more distant parts of the body." Tiger Zhu, CEO of SynCardia China, pointed to the thick wall of the left ventricle on a heart model as he spoke.

This difference in thickness is because the left ventricle needs to pump blood into the systemic circulation to supply the entire body, while the right ventricle only needs to pump blood into the pulmonary circulation. However, whether it is left heart failure or right heart failure, it will gradually affect the other side of the heart, leading to overall functional impairment. Once both the left and right ventricles lose function simultaneously, developing into biventricular failure, life enters a countdown. In the past, waiting for a suitable heart donor was almost the only hope for patients like these.

The "Report on Cardiovascular Health and Disease in China" shows that China currently has about 12 million patients with heart failure, of which approximately 5% (or 600,000) are in end-stage heart failure, falling within the reasonable estimated range of 3%-5% in clinical terms. According to statistics from the *Chinese Circulation Journal*, in 2024, China completed approximately 1,064 heart transplant surgeries (globally, about 5,500 are performed annually) — the enormous gap between supply and demand has caused countless lives to fade while waiting.

It is against this backdrop that a medical device capable of fully replacing the human heart function, surpassing ventricular assist devices, has emerged —Total Artificial Heart (TAH)Came into being. Since gaining FDA approval in 2004,The world's first total artificial heart developed by SynCardia has been put into use across 27 countries and regions, providing a new treatment option for end-stage heart failure patients aged 8 to 82.。

70cc and 50cc Total Artificial Heart, Image Source: SynCardia

Recently, VCBeat conducted an exclusive interview with Tiger Zhu, CEO of SynCardia's Chinese joint venture subsidiary, NewHeart Medical. He shared the story of the world’s only total artificial heart to have received FDA approval in the United States, an eighty-year journey of hardcore technological innovation, and the industrial transformation it is poised to bring to China’s heart failure market.

In March, which has just ended,Global Heart Failure Therapy Annual Meeting (THT 2026)On site, SynCardia, as the leading company in the global artificial heart industry, shifted the focus of its clinical data release from "how long can patients survive" to "how well patients live."

Data shows that among patients treated with the SynCardia Total Artificial Heart, 95% improved from NYHA Class IV to Class I-II, which is the ideal clinical outcome following total artificial heart implantation. At six months post-implantation, the average score on the quality of life scale increased by 35%, with the most significant improvement seen in the physical function dimension—patients reported being able to resume daily activities, including walking independently, eating, and even engaging in light exercise. Additionally, their anxiety and depression scores significantly decreased.

This sends us a signal:As a cutting-edge medical technology, the total artificial heart not only saves lives but also helps patients rebuild confidence in living——Live Longer, Live Better.

In terms of product structure, the SynCardia Total Artificial Heart consists ofImplantable part and external driving partComposition. The implanted part includes two artificial ventricles and four valves, using specialBiocompatible Material (Polyurethane)Made of, this material is also a commonly used implant material in clinical practice, featuringAnti-fatigue, Anti-thrombosisFeatures, and the product itself hasOver One Billion TimesThe anti-fatigue performance; the percutaneous external driver is connected to the implanted part through two tubes, using air and vacuum pulses generated by a pneumatic pump to inflate and deflate the diaphragm within the left and right ventricles, thereby driving blood circulation within the body.

In clinical practice, ventricular assist devices（VAD）Divided into three categories: left heart, right heart, and biventricular assist, andOnly applicable to single ventricular failureThe left ventricular assist device is the mainstay; while the SynCardia total artificial heart targets end-stage cases of complete biventricular failure, requiring the removal of the patient’s original diseased ventricles before implantation, making it a true "heart replacement" solution.

Specifically,The key difference between the SynCardia Total Artificial Heart and ventricular assist devices is that the total artificial heart can simulateFrank-Starling Curve——The greater the venous return, the stronger the myocardial contractility, and the larger the output volume. This means that a healthy heart has the ability to self-regulate, automatically adjusting its output according to the body's needs. Similarly, the SynCardia Total Artificial Heart automatically adjusts its pumping output based on changes in venous return, achieving the same effect as the heart's "heterometric autoregulation."

"Whoever can simulate this curve can truly replace the native heart," emphasized Tiger Zhu, CEO of Neucor Therapeutics.

Secondly,For the extracorporeal drive section,Tiger Zhu introduced, "We keep the simple parts inside the body and place the complex parts outside. This design concept allows us to continuously iterate and upgrade the external driving components with technological advancements without the need for secondary surgeries." From the first-generation CSS driver, the size of a washing machine, to the second-generation C2 driver, the size of a pushcart, and then to the third-generation portable Freedom driver that can fit into a backpack, SynCardia has not only achieved the transformation of its product from the laboratory to clinical use but also continued to optimize and iterate.According to the disclosure, "The latest generation of the driver has been reduced to the size of a palm, weighing less than two kilograms, and features a longer battery life and lower noise levels, which will further enhance the user experience and quality of life for patients."

External drive, image source: SynCardia

In the medical field, time is the best "moat."To date, the SynCardia Total Artificial Heart has over 40 years of clinical application history — with global implantations surpassing 2,200 cases, accumulating over 800 years of patient survival time. The longest-living implant recipient has been healthy for 8 years, and someone even completed a half marathon while using it.

For a long time, the fully implantable artificial heart has been considered one of the most engineering-complex fields in the cardiovascular medical device industry. Although with existing technology, patients can go home with the Freedom driver backpack, their bodies still need to be connected to external equipment through two tubes, and these percutaneous tubes are also the main source of infection for artificial hearts.

SynCardia's latest generation fully implantable artificial heart, Emperor, which is currently under development, will completely eliminate the percutaneous driveline, creating an "Iron Man heart" with all power and control systems implanted inside the patient’s body."We continue to innovate while inheriting the past. Emperor retains the original pulsation patterns and valve implant materials that have been clinically validated over decades, while keeping up with technological advancements by making the driver smaller—so small that it can be directly implanted in the body."Tiger Zhu said.

Emperor, Image Source: SynCardia

The new generation of fully implantable artificial heart, Emperor, addresses the core pain points of traditional artificial hearts, such as "poor portability" and "dependence on external drivers," further improving patient outcomes while expanding the accessibility of artificial heart support technology.

Product innovation is the greatest leverage in the business world. The emergence of Emperor has shed new light on the global challenge of "insufficient cardiac donors," potentially revolutionizing the current landscape of heart failure treatment and bringing humanity's vision of longevity from science fiction closer to reality. At the same time, this groundbreaking iterative innovation has allowed SynCardia, which has dominated the total artificial heart field for 40 years, to once again stand at the forefront of technological advancement, further solidifying its position as a global leader.

According to Tiger Zhu, Emperor has completed six preclinical animal experiments based on a miniature pig model in the United States. The miniature pig is a commonly used model for preclinical research of cardiovascular implant devices, and its physiological structure is highly similar to that of the human heart.The experimental results showed that all animal models were successfully weaned from cardiopulmonary bypass, and the implantation process was complication-free, which is the core evaluation criterion for preclinical trials.

Moreover, throughout the entire observation period, Emperor achieved full and stable blood circulation, with functional performance closely mimicking human heart physiology, completely meeting the laboratory's preset performance standards. Notably, Emperor's first Chinese patent was also approved by the China National Intellectual Property Administration in 2025.The company is also in communication with the U.S. FDASynchronizationCommunicate the Future Human Clinical Trial Protocol。

Total artificial heart belongs to Class III medical device, which is also the highest risk level in China's medical device classification. It requires approval from the National Medical Products Administration (NMPA). With a long research and development cycle, high clinical costs, and stringent reliability requirements, it demands long-term follow-up data and commercial validation. Globally, few enterprises and investors can afford to commit such substantial resources. SynCardia’s decades-long dedication to self-iteration has not only built a deep technological moat but also set an insurmountable competitive barrier for newcomers with its innovative courage to constantly challenge and surpass itself.

As a Sino-US joint venture between SynCardia and China, how to localize this globally leading innovation in China and benefit tens of thousands of heart failure patients is the mission of New Heart Medical——On the one hand, promote the registration and market launch of the fully artificial heart product in China to achieve local implementation; on the other hand, transfer part of the R&D and production lines to China to reduce costs and increase efficiency, realizing "Made in China, serving the globe."

Tiger Zhu stated"The type inspection of the SynCardia total artificial heart is about to be completed, and we will soon be able to officially submit the registration application for Class III medical devices.The entire process fully complies with the requirements of the "Medical Device Registration Administration Measures."”

With the completion of the R&D and production base in Beijing, the decline in cost has also become an inevitable trend."The goal of XinXin Medical is to control the price of the total artificial heart at a level comparable to heart transplantation, making it an affordable treatment option for ordinary families. Carmat, one of only two globally approved commercial total artificial heart companies, went bankrupt precisely because it failed to reduce costs — we will not make the same mistake."

According to the introduction,Dr. Fang Yuncai, Chairman of New Heart Medical, was the first to introduce overseas ultrasonic knife stapler technology into China, reducing the product price from thousands of yuan to hundreds of yuan, saving tens of billions of yuan in medical insurance expenditure for the country every year.In the future, the total artificial heart project will also follow the development logic of "introduction-cost reduction-universal benefit."

On a deeper level, Neucor Medical's goal is far more than just a single product; it is a...A New Ecosystem for Heart Failure Diagnosis and Treatment"For heart failure patients, from lifestyle intervention, medication treatment, to ventricular assist devices, and then to a total artificial heart, it should be a phased, full-cycle management process. Our goal is not to perform surgery for the sake of surgery, but to effectively delay the progression of patients into end-stage heart failure," Tiger Zhu said.

To support the implementation of this ecosystem,Xinxin Medical also plans to"Overseas Training + Practical Operations in China + Mentorship by Oversees Experts"The model systematically introduces mature surgical techniques into China, promoting the construction of a "Multimodal Artificial Heart Transplant Center."Tiger Zhu pointed out, "The implantation surgery of a total artificial heart is actually simpler than a heart transplant. This surgery does not require donor matching, and the operational process is more streamlined. Although doctors in China have not yet led such surgeries, many experts already have experience observing them overseas."

Total Artificial Heart Surgical Procedure, Image Source: SynCardia

In the long term, New Heart Medical also plans to gradually transform into a company truly rooted in China. Tiger Zhu emphasized,"Balancing the Chinese and global markets is a key focus of SynCardia's commercialization strategy. As operations expand, Xinxin Healthcare will also leverage industry-academia-research collaboration and capital support to accelerate technology implementation and product accessibility."

Although medical technology and biotechnology are rapidly advancing at an unprecedented pace, the shortage of donor organs remains a real global challenge to this day. A fully artificial heart represents not only survival but also meaningful recovery, improved quality of life, and the preservation of more transplantation possibilities. "As an industry leader, we hope that more innovative products will bring hope to patients with end-stage heart failure in the future, and through industry collaboration, we can continue to advance and popularize artificial heart technology," Tiger Zhu concluded in the interview.