Core Medical's DuoCor 2 Biventricular Assist System Approved for Clinical Trials, Breaking into Whole Heart Failure 'No Man's Land'

China's medical device industry is poised to break into territory that has long eluded even the most established players in the artificial heart sector. Shenzhen Core Medical Technology Co., Ltd. recently received regulatory approval to begin clinical trials for its DuoCor 2 implantable biventricular assist system—making it the first such device in China to enter human testing and potentially the world's first fully magnetically levitated bVAD system to reach that milestone.

The approval from the Center for Medical Device Evaluation under China's National Medical Products Administration marks a significant step forward in addressing what cardiologists have long considered a glaring gap in treatment options: whole heart failure. While the medical device industry has spent decades perfecting left ventricular assist devices, or LVADs, for patients with left-sided heart failure, those with failure affecting both sides of the heart have been left with far fewer options—and far worse outcomes.

The numbers tell a stark story. According to Frost & Sullivan data, approximately 6.06 million patients worldwide suffered from end-stage heart failure in 2024, with more than 1.5 million of them in China. The four-year survival rate for these patients hovers around 10%. But within that patient population, outcomes vary dramatically based on which part of the heart has failed.

Epidemiological research shows that roughly 32% of end-stage heart failure patients experience moderate or severe right ventricular dysfunction, requiring biventricular circulatory support or prevention. For patients with whole heart failure, the two-year survival rate plunges to just 23%, compared to 71% for those with left heart failure alone. In China, end-stage whole heart failure patients account for approximately 40% of the total end-stage heart failure population, making the unmet clinical need particularly acute.

For these patients, a left ventricular assist device alone is insufficient. China's 2024 Guidelines for the Diagnosis and Treatment of Heart Failure explicitly state that patients with concomitant right heart failure should be considered for biventricular assist devices. Yet until now, no dedicated solution has been available.

The workaround has been crude: clinicians sometimes combine two separate LVADs, modifying one to support the right heart. But this approach comes with significant drawbacks. Patients must carry two percutaneous cables, two controllers, and typically four batteries. The complexity increases the risk of device failure and infection while severely limiting portability. Clinical data show that pump thrombosis rates under this arrangement can reach 36% to 37%, driven by the challenging hemodynamics of right ventricular support and the limitations of adapting left-sided devices for right-sided use.

Globally, no fully magnetically levitated biventricular assist system has received regulatory approval. The market currently offers only implantable left ventricular assist systems, with no approved devices specifically designed for end-stage right heart failure or whole heart failure.

The Engineering Challenge of Supporting Both Hearts

Understanding why biventricular support has proven so difficult requires appreciating the fundamental asymmetry of human cardiac physiology. The left ventricle pumps blood through the systemic circulation, generating pressures of approximately 120 mmHg to reach the body's tissues. The right ventricle, by contrast, pumps blood through the pulmonary circulation at pressures of only about 25 mmHg. Yet the flow volumes from both ventricles must match precisely—any imbalance can quickly lead to pulmonary or renal dysfunction, circulatory collapse, or multi-organ failure.

This physiological reality places extraordinary demands on control algorithms. A biventricular assist device must continuously adapt to the different pressure and compliance characteristics of the systemic and pulmonary circuits while maintaining perfect flow balance. The precision required far exceeds that of a single ventricular assist device.

The right ventricle itself presents additional challenges. Its walls are thinner and its contractile force weaker than the left ventricle. The anatomical space is more constrained, demanding smaller, lighter pump components. The right heart operates in a venous blood environment where blood flow is slower and more prone to stasis, elevating thrombosis risk and placing extreme demands on blood compatibility. These factors mean that existing LVADs cannot simply be repurposed for right ventricular support—the device must be redesigned from the ground up to match right ventricular physiology.

Then there is the tripartite constraint of volume, power consumption, and reliability. An implantable biventricular device must fit two pumps within the limited space of the human chest. Driving two pumps requires significantly more power than driving one, yet the device must minimize energy use to ensure long-term reliability and excellent blood compatibility. The external components must also be light enough to allow patients to maintain a reasonable quality of life while carrying the system.

These overlapping constraints explain why biventricular assist devices have largely remained confined to research laboratories—and why Core Medical's approach represents a departure from conventional designs.

Building on Proven Technology

Core Medical's entry into biventricular support did not begin from scratch. The foundation is Corheart 6, the company's implantable left ventricular assist system that received regulatory approval in 2023 and has since become the most widely used artificial heart in China by implant volume.

Corheart 6 employs an axial full magnetic levitation motor architecture and a proprietary control technology that the company describes as time-sharing and zone-based dynamic axial full magnetic levitation control. The key innovation lies in using a single set of coils to simultaneously drive impeller rotation and maintain magnetic levitation—a departure from traditional magnetic levitation artificial hearts that rely on multiple coil sets for suspension and rotation, resulting in more complex, larger, and more power-hungry designs.

This approach has yielded a device that, according to the company, is currently the smallest and lightest commercial full magnetic levitation implantable artificial heart in the world, with a diameter approximately 30% smaller and weight more than 50% lighter than international competitors. By terminal implant volume, Corheart 6 captured over 45% of the Chinese market in 2024 and more than 52% in the first five months of 2025. As of the date of its prospectus filing, the device had been used in more than 1,300 clinical cases, generating 164 million RMB (approximately $22.6 million) in revenue during 2025.

Clinical outcomes have been closely watched. Long-term follow-up data from Corheart 6's registration clinical trial, published in the European Journal of Cardio-Thoracic Surgery, showed a two-year survival rate of 86%. During the two-year follow-up period, no pump thrombosis, hemolysis, or device failure events occurred. The study, based on a prospective registration clinical cohort, represents the first long-term artificial heart study in a Chinese population and is considered a gold-standard evaluation for medical devices.

The implication is clear: DuoCor 2 is not an experimental concept but an extension of technology that has already undergone rigorous clinical and commercial validation. Core Medical is applying its proven miniaturization, low power consumption, and full magnetic levitation capabilities to solve the specific challenges of biventricular support.

The company's research and development investment has been substantial. From 2023 to 2025, cumulative R&D spending reached 473 million RMB (approximately $65 million). By the end of 2025, the company had secured 253 domestic authorized patents, including 115 invention patents. Four of its core products have been included in China's Innovative Medical Device Special Review Procedure.

DuoCor 2's System-Level Solutions

The DuoCor 2 system addresses the three core technical challenges through targeted design innovations.

To tackle the asymmetry between left and right heart physiology and the difficulty of coordinated control, DuoCor 2 employs a proprietary dual-pump intelligent coordination control system. A single external controller manages both pumps in an integrated and intelligent manner, enabling precise monitoring and dynamic adjustment of left and right pump flow to maintain balance. This fundamentally resolves the coordination problems inherent in the dual-LVAD approach, which requires two separate controllers operating independently.

For the right ventricle's demanding physiological environment, the company developed what it describes as the world's first magnetically levitated right heart pump. According to its prospectus, the right pump weighs just 68 grams, while the left pump weighs 73 grams. This design specifically accommodates right ventricular physiology and hemodynamic characteristics. Combined with intelligent control technology, it enables precise regulation of right heart flow, reduces pump thrombosis risk, and improves blood compatibility—directly addressing the high right heart pump thrombosis rates seen with current solutions.

To address the volume, power consumption, and reliability constraints, DuoCor 2 integrates the entire system into a lightweight configuration. The setup uses just one external controller and one percutaneous cable, replacing the two cables, two controllers, and four batteries required by the dual-LVAD workaround. This reduction in components lowers the risk of device failure and infection while improving system reliability and long-term operational stability. The miniaturized biventricular design also reduces requirements for patient body surface area and thoracic volume, potentially expanding the eligible patient population.

Clinical Value and Development Progress

From a product design perspective, DuoCor 2 aims to address several critical pain points in whole heart failure treatment. Reducing the number of percutaneous cables from two to one means fewer skin entry sites and less cable exposure, directly lowering the risk of percutaneous cable infection—one of the most significant complications following artificial heart implantation.

The right heart-specific design optimizes flow pathways to address the slow venous blood flow and stasis tendencies, while intelligent control provides improved flushing effects to reduce pump thrombosis risk and enhance blood compatibility. The integrated control system replacing the dual-system workaround should improve long-term product stability. And the integrated, lightweight external components reduce the burden of carrying equipment long-term, offering greater convenience for extended support outside the hospital.

These improvements stand in sharp contrast to the current reality for whole heart failure patients, whose two-year survival rate of 23% underscores the urgency of better treatment options.

In terms of regulatory progress, DuoCor 2 entered China's Innovative Medical Device Special Review Procedure in November 2024. The recent approval for clinical trials marks its entry into clinical evaluation. On the international front, DuoCor 2 has already initiated clinical trials in Europe.

In autumn 2025, the Leipzig Heart Center in Germany completed a DuoCor 2 implantation in a 67-year-old patient with end-stage heart failure. The patient, who was not a candidate for heart transplantation due to his physical condition, received the device as a final treatment option and has since recovered and been discharged. According to available information, this was the third such procedure performed in Europe.

The product is expected to potentially become the world's first approved implantable biventricular assist system, conferring significant first-mover advantage.

Looking Ahead

From an industry perspective, previous breakthroughs in China's domestic artificial heart sector primarily addressed the transition from no left ventricular assist device to regulatory approval and clinical application. Biventricular support confronts more complex patients, more demanding hemodynamic management, and stricter requirements for long-term implant reliability—pushing Chinese artificial heart technology and application into an entirely new phase.

The emergence of DuoCor 2 means that the applicability of artificial hearts will no longer be limited to left heart failure but will extend to whole heart failure—a large patient population that has long lacked effective product coverage. For patients with end-stage whole heart failure, this clinical approval signals that a solution truly designed at the system level for biventricular failure is moving from the laboratory into clinical validation.

Whether the global "no man's land" of biventricular assist devices can be filled depends on future clinical data. But at minimum, this long-unresolved global challenge now has a systematic approach to solving it—and an opportunity to break through.