China's First Interventional Artificial Heart CorVad Gains Regulatory Approval as Core Medical Files for STAR Market IPO
Core Medical
Artificial Heart Series Product Developer
Source: Heart Future
On December 24, 2025, the National Medical Products Administration approved the registration application for the interventional left ventricular assist device and the interventional left ventricular assist catheter pump kit from Shenzhen Core Medical Technology Co., Ltd. ("Core Medical").China's First Domestically Produced Interventional Left Ventricular Assist System CorVad Officially Approved for Marketing, with Registration Certificate Numbers Z20253122653 and Z20253122652.
The interventional left ventricular assist device and the interventional left ventricular assist catheter pump kit are used in combination for high-risk percutaneous coronary intervention (PCI), providing left ventricular assistance to adult patients with severe coronary artery disease, reduced left ventricular ejection fraction, and stable hemodynamics.
This system adopts miniaturized axial motor technology for short-term left ventricular assistance. It is a pioneering technology in China, filling the gap in domestically interventional cardiac assist devices.
With the increasing aging of the population with coronary heart disease, the number of complex coronary artery disease cases complicated by severe left ventricular dysfunction is rising year by year in clinical practice. For these patients, percutaneous coronary intervention (PCI) is often associated with a higher hemodynamic risk, and a sudden drop in cardiac output during the procedure may lead to serious complications or even life-threatening situations.
Statistics from Frost & Sullivan show that the global number of high-risk PCI procedures reached 2.217 million in 2024, with a compound annual growth rate (CAGR) of 12.1% from 2019 to 2024; it is expected 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, of which 193,000 were high-risk PCI procedures; it is projected that by 2033, the number of PCI procedures in China will rise 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.
In this scenario, interventional ventricular assist devices are gradually becoming an important support method.
The interventional ventricular assist device is a miniaturized blood pump inserted into the ventricle through percutaneous intervention. By the action of the blood pump, it pumps blood into the arterial system, partially or completely replacing the heart's pumping function to maintain the body’s blood circulation. It is mainly used to provide medium- to short-term circulatory support for patients in scenarios such as cardiogenic shock treatment and high-risk coronary artery interventions.
However, before CorVad was approved,China has not yet approved any domestically produced interventional artificial heart products, and related clinical needs have long relied on imported devices.This also makes the field one of the most challenging directions in the high-end medical device localization in China.
CorVad adopts miniaturized built-in axial motor technology, which can effectively share the workload of the left ventricle, pump blood into the aorta, rapidly improve perfusion of organs throughout the body, and enhance surgical safety.
Core Medical's CorVad interventional artificial heart product, developed based on axial magnetic flux multi-drive technology, achieves a new breakthrough in in vivo motor technology. The company has developed a range of interventional artificial heart products with multiple pipelines and models to meet the needs of different patients and clinical scenarios. This is expected to fill the gap in China’s medium- and short-term artificial heart market and help many patients with acute heart failure and other critical cardiovascular conditions overcome challenges.
Core Medical was founded in August 2016, with its headquarters located in Shenzhen. It 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"). The company has achieved a comprehensive layout in the field of implantable and interventional artificial hearts, and is committed to providing a complete solution 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 surpassed the equivalent levels of international counterparts, significantly enhancing the competitiveness of domestically produced artificial hearts in the global market.
At the same time, based on the expansion of technical boundaries in the field of artificial hearts through "time-sharing and zone-based axial full magnetic suspension control technology," Core Medical continues to lead the miniaturization of artificial hearts. It has developed the integrated full magnetic suspension dual ventricular assist system DuoCor®, which helps address long-term treatment challenges in the field of right heart and biventricular heart failure globally, filling the "unexplored territory" in the global industry.
In product lines such as the interventional artificial heart CorVad, Core Medical has also carried out innovative R&D to achieve a large 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.
Core Medical focuses on three core products: Corheart®6, DuoCor®, and CorVad, comprehensively covering implantable and interventional artificial hearts, providing a full range of solutions for over 60 million heart failure patients worldwide.
1. The First Case Accepted After the Resumption of the Fifth Set of Listing Standards for the STAR Market
On November 6, 2025, the Shanghai Stock Exchange's official website disclosed that Shenzhen Core Medical Technology Co., Ltd.'s Sci-Tech Innovation Board IPO application has been officially accepted.
This is the first innovative medical device company to apply and be accepted under the fifth set of listing standards for the Sci-Tech Innovation Board after its restart.
The fifth set of standards focuses on "market value + core technology + phased achievements" as the core judgment logic, without setting a profitability threshold, mainly targeting hard-tech enterprises with long R&D cycles, high investment, and尚未实现盈利.
Against the backdrop of the long absence of substantial cases under this standard, Core Medical's application is seen by the market as a demonstration-worthy attempt.
2. Financing Situation
In April 2025, Core Medical announced the completion of an oversubscribed Series D financing round exceeding 100 million US dollars to accelerate innovative product development and advance the company's international strategic layout. This was one of the largest market-driven financings in China's innovative medical device sector that year.
The investors include several well-known institutions such as Loyal Valley Capital, Legend Capital, Prosperity7 Ventures, and Cornerstone Capital.
The prospectus disclosed that the company has received multiple rounds of institutional investment and has been recognized as a company supported by senior professional institutional investors in accordance with the "Guidance No. 8 on the Application of Listing Review Rules."
1. The Phase Competition in China's Artificial Heart Sector
Currently, the field of artificial hearts in China has formed a pattern with multiple enterprises advancing in parallel, including Aerospace Tixin, Core Medical, Eternal Heart Medical, and Heart Power Medical.
In the implantable field, although Core Medical was the last of the "Four小龙" to receive approval, Corheart® 6 achieved rapid clinical penetration in the early stages of its market launch.
In the interventional field, with the approval of CorVad, China now has its first independently controllable high-risk PCI circulatory support solution.
2. International Competition and Benchmarking Objects
In the global market, the implantable field has long been dominated by Abbott's HeartMate 3, while the interventional field is represented by Johnson & Johnson's Impella series.
As of the end of 2024, the global cumulative implant volume of HeartMate 3 has exceeded 35,000 units; the annual sales of the Impella product line are close to 1.5 billion US dollars, with a double-digit annual growth rate.
Core Medical is regarded as one of the local enterprises in China attempting to build a "full-process solution for heart failure" by simultaneously developing implantable and interventional products.
The artificial heart is regarded as the "jewel in the crown" of the medical device field, and its research, development, and industrialization levels are often considered an important indicator for measuring a country's high-end medical equipment capabilities.
The approval of CorVad’s interventional left ventricular assist system marks that Chinese companies have achieved a complete breakthrough in the high-barrier field of interventional ventricular assistance, from technology research and development, engineering implementation to regulatory approval. For China's cardiovascular medical device industry, this not only means the addition of a new product but also represents substantial progress in the independent and controllable capability of critical emergency core equipment.
From regulatory approval, clinical application to capital market testing, Core Medical is at the intersection of multiple key nodes.
In the high-risk, high-technical-threshold field of artificial hearts, product approval is just the starting point.
Subsequent real-world applications, long-term safety validations, and commercial sustainability will determine how far China-produced solutions can go.
This article is reprinted, all views belong to the original author.Platform, Medical DeviceMedical Device DealerIndustryThe comments remain neutral on all viewpoints in the article and are solely for sharing and exchange.
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