Shenzhen CoreMed's Implantable Biventricular Assist System DuoCor Granted Entry into NMPA's Innovation Review Pathway

In terms of auxiliary effects, the blood flow sensor must simultaneously and in real-time adjust the pump's rotational speed and output power. For safety reasons, the cable connecting the pump to the control unit needs excellent biocompatibility to reduce the risk of infection and thrombosis. Moreover, it should be lightweight and portable to ensure the patient’s quality of life. Ultimately,A single control system with an external device weighing only 0.8kg and a cable diameter of no more than 5mm has been born., and applied for a national invention patent on May 31, 2024.

July 2023,Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyProfessor Dong Nianguo and Professor Xia Jiahong from Wuhan Union Hospital led their team to successfully perform an implant surgery using DuoCor on a patient with end-stage biventricular heart failure, significantly improving the patient's condition.

Patient Details

The patient is a 57-year-old female who, since August 2018, has experienced symptoms such as chest tightness, shortness of breath, and fatigue. Cardiac ultrasound examination revealed left heart enlargement and segmental wall motion abnormalities in the left ventricle, leading to a diagnosis of heart failure. In January 2024, the patient's symptoms recurred, accompanied by dry heaves, decreased appetite, difficulty lying flat at night, and significantly reduced exercise tolerance.

Diagnosis Result:Dilated Cardiomyopathy, End-Stage Heart FailureCardiac function Class IV, INTERMACS Level III; moderate tricuspid regurgitation, mild to moderate mitral regurgitation; sinus rhythm, frequent polymorphic ventricular premature beats; pulmonary nodules, segmental atelectasis; atherosclerosis of the aorta, carotid artery atherosclerosis.

Surgical Plan

The surgical team decided to introduce an innovative dual-heart assist system treatment plan. This system achieves synchronized assistance for both sides of the heart by accessing the left ventricle and right atrium, and connecting artificial blood vessels to the aorta and pulmonary artery respectively.

Intraoperatively, test-run the left and right ventricular assist pumps to ensure proper function, pre-install the artificial blood vessel and its protective sleeve; expose the heart fully via median sternotomy.Systemic heparinization was performed, an extracorporeal circulation system was established, and a needle for perfusion of cardioplegia solution was placed. Meanwhile, a left atrial drainage tube was inserted through the left atrium. A percutaneous cable was pulled using a thread knife to ensure that the part wrapped in Dacron remained subcutaneous and the intracorporeal connector stayed inside the body.

Initiate cardiopulmonary bypass, occlude the ascending aorta, and perfuse cardioplegia to induce cardiac arrest; complete the left ventricular apical purse-string suture.Opening in the Left Ventricle and Implanting an Assist Pump, After the heart resumed beating, the right atrial appendage was sutured in the same way.Create an opening in the right ventricle and implant a right ventricular assist pump；Anastomose the artificial vessel with the ascending aorta and pulmonary artery; start the biventricular assist pump and vent.; Finally, adjust the flow as needed and gradually stop the extracorporeal circulation.

On the first day after surgery, the tracheal tube was successfully removed. Echocardiography showed that LVEF increased from 16% preoperatively to 28%, RVEF increased from 23% preoperatively to 31%, LVED decreased from 5.9 cm preoperatively to 5.5 cm, and RA decreased from 5.5 cm preoperatively to 4.8 cm. On the second day after surgery, the patient was able to engage in moderate rehabilitation activities under the guidance of medical staff and resumed oral intake; cardiac function significantly improved. The patient was transferred to a general ward on the fourth day after surgery.

According to the 2024 Chinese Heart Failure Diagnosis and Treatment Data released by the National Medical Quality Control Center for Cardiovascular System Diseases: In 2023, the number of hospitals treating heart failure patients in secondary and tertiary hospitals in China totaled 7,374, increasing by 36.5% compared to 2022.The number of hospitalized heart failure patients increased by 38.9% compared to 2022, from 10.29 million cases to 14.29 million cases, accounting for 18% of all cardiovascular disease hospitalizations.Among them, the proportion of elderly people aged 65 and above reached 74%, reflecting that the intensification of population aging has increased the disease burden of heart failure.

Ventricular Assist Device (VAD) is a mechanical device used to assist the heart's pumping function, typically for patients with heart failure. Depending on the ventricle being assisted,VAD can be further classified:

In patients with heart failure, left ventricular failure is the most common. Since 2017, 132 hospitals across China have completed 908 cases of LVAD implantation involving four different models, with the number of LVAD implants increasing annually. Among these hospitals, 23 (17%) have performed more than 10 implantations each, accounting for 627 cases (70%) of the total implant volume. However, approximately 30% of end-stage heart failure patients experience biventricular failure, meaning both the left and right ventricles exhibit insufficient ejection capacity. In such cases, implanting an LVAD alone does not achieve the desired outcomes.Patients Need Full Support。

In addition, although the isolated implantation of LVAD is highly effective for patients with left heart failure, it increases the burden on the right heart due to enhanced left ventricular output. This requires a certain level of right heart function to adapt to the hemodynamic changes brought by the LVAD after implantation. Long-term follow-up studies on LVAD implantation internationally have found that,Approximately 10%-30% of patients will experience varying degrees of right heart failure symptoms after LVAD implantation.。

Although the total artificial heart (TAH) is an option, its large size, complex structure, and high cost have limited its clinical application. In contrast,Biventricular Assist System (BiVAD) preserves the patient's original heart and provides more balanced hemodynamic support., and when the device fails, the original heart can partially maintain cardiac output, which improves rescue rates, results in fewer clinical adverse events, and may potentially promote myocardial recovery. This is the future trend in the treatment of biventricular heart failure.

In 2001,Impella Cardiotechnik AGThe dual-heart assist system obtained the European CE certification. Subsequently, the Intracardiac Pump LV 6.4 in the dual-ventricular assist system was renamed to Impella LD and Impella 5.0, which obtained CE registration certificates in 2002 and 2003 respectively. The company was later acquired by the American company Abiomed (a subsidiary of Johnson & Johnson).

MI-VADThe company is also researching a new type of interventional ventricular assist device—MI-VAD. MI-VAD consists of three main components, providing minimally invasive treatment for patients with Class III and IV heart failure. It can be implanted in the supravalvular position of the aorta or pulmonary artery, effectively enhancing and restoring left or right ventricular cardiac function in patients with dilated or restrictive cardiomyopathy. The device does not require sternotomy or extracorporeal circulation, is fully implantable, and can be wirelessly charged. It also allows for diagnosis and programming via a smartphone, offering patients greater freedom, comfort, and an improved quality of life while eliminating the risk of infection caused by external connections.

However, the research on biventricular assist devices in China is still in its infancy, with relatively few clinical application cases. In April 2022, Director Nian-Guo Dong of the Department of Cardiac and Great Vessel Surgery, in collaboration with Core Medical, began developing a "single control system for biventricular assist."Device," and completed the first clinical application, marking a major breakthrough in artificial heart assist technology in China.

Xin Heng Rui Medical also adopts a multi-pronged approach, innovatively developing percutaneous ventricular assist devices, implantable ventricular assist devices, and implantable dual-heart assist devices, creating a trinity of mechanical circulatory support devices more suitable for Chinese patients.

As of the date of publication, four ventricular assist devices (Suzhou T同心 Pump, TEDA "Rocket Heart", Shenzhen Core Pump, Chongqing "Eternal Heart") have been approved for marketing by the National Medical Products Administration (NMPA) in China, all of which are LVADs, providing more treatment options for end-stage heart failure patients. As of May 31, 2024, the "Rocket Heart" has completed 166 surgical implants, with a two-year survival rate of 88% and a three-year survival rate (free from disabling complications) of 83.5%, results that are very encouraging as they approach those of heart transplantation.

With the continuous development and improvement of ventricular assist device technology, its application prospects in treating end-stage heart failure are becoming increasingly broad. In the future, ventricular assist devices are expected to achieve smaller size, lighter weight, better blood compatibility and tissue compatibility, as well as more intelligent control and monitoring systems. This will make ventricular assist devices a treatment option for more patients with end-stage heart failure and is expected to replace heart transplantation as one of the main methods for treating advanced heart failure.

Shenzhen Core Medical Technology Co., Ltd. was established in August 2016, with its headquarters located in Shenzhen. The company focuses on the research, development, and production of high-end innovative medical device products, such as mechanical circulatory assist devices (commonly known as "artificial hearts"). It has achieved a comprehensive layout in the field of implantable and interventional artificial hearts, and is committed to providing a full range of solutions for heart failure patients worldwide.

In the miniaturization of artificial hearts, the key performance indicators of Corheart® 6, an ultra-small fully magnetically levitated artificial heart independently developed by Core Medical, have reached the same level as international counterparts, significantly enhancing the competitiveness of Chinese-produced artificial hearts in the global market.

In product lines such as the interventional artificial heart CorVad, Core Medical has also carried out innovative R&D to achieve a larger flow rate within a smaller interventional size. Its self-designed micro motor and control technology have further reduced the risk of hemolysis, enhancing product stability and long-term operational reliability.

Since 2019, Core Medical's innovative achievements in the artificial heart field have been highly favored by the capital market, completing 5 rounds of financing in five years, with a steady development momentum.

As of the date of this report, the company's financing history is as follows:

Dr. Yu Shunzhou, the founder of Core Medical, graduated from Harbin Institute of Technology. After completing his Ph.D. at HIT, Yu Shunzhou went to the University of California, Davis for further studies in mechanical engineering. In 2011, by chance, he was introduced to the field of artificial hearts and began working as a senior engineer at a top U.S. artificial heart company, where he participated in the development of several artificial heart products, including Heartmate 3 – the world’s most advanced left ventricular assist device.

In 2016, Medtronic's acquisition of HeartWare, the second-ranked company in the artificial heart field, for $1.1 billion made headlines. At that time, the prevalence of cardiovascular diseases in China continued to rise, while heart transplant donors were extremely scarce, and heart failure was dubbed the "final battlefield" in the cardiovascular field. Witnessing all this, Yu Shunzhou decided to return to China to start a business, leading to the establishment of Core Medical.

Seemingly a natural and effortless decision, but behind it lies a little-known detail: Yu Shunzhou's mother is also a heart failure patient. He once frankly said when talking about his entrepreneurial journey: "I have a heart failure patient in my family, so I deeply understand the longing for life and the desire for quality of life that heart failure patients have."

In 2016, Yu Shunzhou returned to China and founded Core Medical, settling in Zhinanyuan, Nanshan, Shenzhen.