Just now,重磅 news came from the artificial heart field. The official website of the National Medical Products Administration shows that Core Medical's interventional left ventricular assist device and interventional left ventricular assist catheter pump kit have been approved for marketing. This is not onlyThe First Interventional Artificial Heart Product Approved for Marketing in China, making Core Medical even moreThe only company in the world to simultaneously possess regulatory approvals for both implantable and interventional artificial hearts.This marks that artificial heart technology made in China has officially entered the world's leading ranks, bringing a turning point for a large number of high-risk cardiovascular disease patients.

The National Medical Products Administration (NMPA) evaluated: "This system adopts miniaturized axial motor technology for short-term left ventricular assistance.This is a pioneering technology in China, filling the gap in domestic interventional cardiac assist device technology.”

This timeCorVad® Approval Marks a Key Breakthrough for High-End Medical Devices in China’s Chokepoint Areas. As an essential aid in the treatment of severe cardiovascular emergencies, interventional artificial hearts have long been monopolized by Impella, a product under Johnson & Johnson. In 2022, Johnson & Johnson acquired Abiomed, the developer of Impella, for a staggering $16.6 billion, setting the record for the company's largest acquisition ever, which underscores the strategic importance of this field.

Data shows,The Impella series has been globally applied in over 400,000 clinical cases, with annual sales reaching nearly 1.5 billion US dollars.According to a survey of American doctors by Frost & Sullivan,High-risk for cardiologists in the United StatesPCIIn UseImpella®The proportion is as high as64%, while traditional methodsIABPThe usage ratio has shrunk to28%。This high usage rate stems from highDangerThe particularity of PCI surgery means that even brief circulatory fluctuations during the procedure may quickly escalate into a vicious cycle due to reduced cardiac output and decreased coronary perfusion pressure, potentially leading to acute heart failure or circulatory collapse, which can seriously endanger life. However, an interventional artificial heart can maintain hemodynamic stability during the operation, helping to reduce surgical risks and improve prognosis.Of critical significance. Prior to thisChina has always lacked similar domestically produced approved products, urgently needed.Severe patients face"The Dilemma of Having No Medical Devices Available"

The breakthrough of Core Medical has completely changed this situation.CorVad® series is its completely self-developed original product,Adopting the internationally pioneering "axial magnetic flux multi-drive motor technology" for intravascular miniaturization, reducing the motor diameter to 4-5 millimeters and achieving a built-in motor design, meaning the motor is placed inside the human blood vessels. This design shortens the transmission distance between the motor and the impeller, minimizing pump vibration during high-speed impeller operation, ensuring high operational reliability, and effectively reducing risks related to hemocompatibility such as hemolysis and tissue damage. Additionally, the internal motor and shorter rigid shaft transmission are less affected by external disturbances, enabling more precise monitoring of blood flow and pump speed. The multi-drive axial motor design with higher magnetic flux density significantly increases the motor's magnetic flux density, effectively improving overall motor efficiency and achieving higher blood flow. The integrated ultra-miniature pressure sensor enables precise hemodynamic monitoring, providing data support for personalized treatment.

The interventional artificial heart is called"Micro-factories in blood vessels" require breakthroughs in multiple technological barriers such as motor miniaturization, blood compatibility, and long-term reliability. Compared with traditional assistive devices and international competitors, CorVad® has achieved a comprehensive upgrade in core performance.

In terms of the clinically most concerned aspect of hemocompatibility,CorVad® Demonstrates Overwhelming Advantages. The specially designed rigid shaft driven by an axial flux motor significantly reduces the friction contact area and minimizes heat generation.The temperature rise of the pump surface is less than 2 degrees Celsius at maximum speed.At the same time, the streamlined low-shear impeller and precision manufacturing processes ensure the stability of the impeller during high-speed operation, prevent bearing vibration, reduce shear force on blood, and significantly minimize blood damage. In vitro hemolysis tests show that, compared to international competitors Impella® CP and Impella® 5.5,CorVad®'s MIH (Modified Hemolysis Index) decreased by nearly 95% compared to international competitors., which means that the risk of serious complications such as bleeding and hemolysis will be significantly reduced for patients.

CorVad® took less than two and a half years from entering the innovation channel to receiving approval.，Significantly earlier than the "expected approval for market launch in the first quarter of 2026" disclosed in its prospectus.This isThe叠加 effect of Shenzhen speed and national innovation policies. The approval of CorVad® not only signifies the success of a single product but also marks that Core Medical has established a comprehensive heart failure treatment system covering "short-term emergency - mid-term transition - long-term support."At present, this full layout of "implantation + intervention" is unique globally.Heart failure treatment is a continuous process. Some patients may require interventional devices (percutaneous ventricular assist devices, or PVAD) for emergency treatment during acute episodes, and after stabilization, they may need implantable devices (left ventricular assist devices, or LVAD) for long-term support. A complete product layout can ensure seamless transition.

Previously, Core Medical developedCorheart® 6 Fully Magnetically Levitated Implantable Artificial Heart was approved in June 2023.This product is currently the world's smallest and lightest commercial fully magnetically levitated implantable artificial heart. Its market share in China exceeded 45% in 2024, ranking first in the industry.Relying on the technical, channel, and brand advantages accumulated in the field of implantable artificial hearts, Core Medical is expected to promote the rapid clinical adoption of interventional products, activating China's enormous potential market for medium- and short-term artificial hearts.

Frost & Sullivan's statistical data shows that the global high-riskThe number of PCI procedures reached 2.217 million in 2024, with a compound annual growth rate (CAGR) of 12.1% from 2019 to 2024; it is projected that by 2033, the global number of high-risk PCI procedures will increase to 5.571 million, with a CAGR of 10.8% from 2024 to 2033. In the Chinese market, the number of PCI procedures in 2024 was 1.906 million, including 193,000 high-risk PCI procedures; it is expected that by 2033, the number of PCI procedures in China will increase to 5.961 million, with the number of high-risk PCI procedures increasing to 772,000, showing a CAGR of 16.7% from 2024 to 2033.

The huge clinical demand has given rise to a rapidly growing market space. According to Frost & Sullivan data,From 2019 to 2024, the global medium- and short-term artificial heart market size grew from US$970 million to US$2.07 billion, with a compound annual growth rate (CAGR) of 16.4%; it is projected that by 2033, the global market size will reach US$9.82 billion, with a CAGR of 18.9% from 2024 to 2033. In the Chinese market, as CorVad® takes the lead in breaking the market void,It is estimated that the market size of China's medium- and short-term artificial heart will reach 11.46 billion RMB by 2033, with a compound annual growth rate (CAGR) of 222.9% from 2024 to 2033.Core Medical is expected to capture a significant share of the market in China and even globally, thanks to its core technological advantages.

The approval of the CorVad® series products not only brings hope to patients with heart failure, but also marks a milestone for the development of China's high-end medical device industry. Artificial hearts are regarded as "the pearl on the crown" in the field of medical devices, involving interdisciplinary fields such as mechanical engineering, material science, and biomedical engineering, making their research and development extremely challenging. The success of Core Medical demonstrates that Chinese companies now possess full-chain technological breakthrough capabilities from motor design, material research and development to precision manufacturing, breaking the technological monopoly of overseas enterprises in the high-end medical equipment sector.

Core MedicalFounded in Shenzhen in 2016, Core Medical has been focusing on the research and development as well as industrialization in the artificial heart field. Several of its products have been included in China's special review process for innovative medical devices, with the number of inclusions ranking first in the artificial heart sector.Currently, the company has developed a portfolio of five implantable and six interventional artificial heart products, achieving comprehensive coverage of all clinical needs from "long-term to short-term support, left ventricular to biventricular support, and pediatric to adult support."Among them, Corheart® 6, the fully magnetically levitated implantable artificial heart, as the company's first commercialized core product, has not only earned the title of "the world's smallest and lightest."It is also China's first implantable artificial heart that can be used for clinical treatment of heart failure in children.`, filling the gap in pediatric heart failure treatment in China, and was awarded the "Important Medical Achievement of China in the 21st Century" by the Chinese Academy of Medical Sciences;`The implantable artificial heart product DuoCor® 2, which is still in the clinical stage, belongs to the "First-in-Class" (first of its kind) category and is expected to become the world's first approved integrated magnetically-levitated dual-heart assist device., solving the long-term treatment challenge of "total heart failure" globally.

With solid technical strength,Corheart® 6, the fully magnetically levitated implantable artificial heart, has successfully gone global, entering international markets. In May 2024, Core Medical initiated the European clinical trial for this product and completed patient enrollment; simultaneously, the company accelerated its international expansion efforts, conducting market development across multiple countries and regions. In June 2025, Corheart® 6 successfully landed in the Americas, obtaining regulatory approval in Colombia and completing the first overseas commercial implantation of a Chinese-made artificial heart, marking a historic breakthrough for domestically produced artificial hearts in breaking monopolies within overseas markets. Looking ahead, as the only company globally to have received regulatory approval for both implantable and interventional artificial hearts, Core Medical is poised to bring the "Made in China" life pump to more heart failure patients worldwide.