China's First Percutaneous Ventricular Assist Device Gains Approval, Filling Domestic Technology Gap

Latest Announcement on the Official Website of the National Medical Products AdministrationDisplay, RecentlyShenzhenCoreCore MedicalTechnology Co., Ltd.The"Interventional Left Ventricular Assist Device"And"Interventional Left Ventricular Assist Catheter Pump Kit"The marketing application has been officially approved. This device is called"China's First Domestically Produced Interventional Artificial Heart", filling the technical gap in the field of interventional cardiac assist devices in China.

For patients with coronary heart disease, myocardial ischemia caused by vascular stenosis or blockage is a serious issue, and high-risk percutaneous coronary intervention requires safer technical support.

FillFilling the VoidWhite

The interventional left ventricular assist system is the first approved product of its kind in China, mainly used forSupport High-Risk Percutaneous Coronary Intervention Procedures。

The system provides short-term left ventricular assistance to adult patients with severe coronary artery disease and reduced left ventricular ejection fraction through minimally invasive intervention.

System AdoptionMiniaturized Axial Motor Technology，A technology that is a domestic first in China, filling the technical gap in China's interventional cardiac assist devices.

Technical Features

The core technology of the system adopts a miniaturized axial flux multi-drive technology independently developed by the company. Compared with existing foreign technologies, this technology can achieve higher blood flow output and more stable performance with a smaller catheter outer diameter.

This technological breakthrough significantly reduces the risk of blood damage and supports longer clinical auxiliary applications. As a leader in the field of left ventricular assist devices in China, the successful launch of Core Medical's product has achieved a breakthrough from zero to one for domestically produced high-end interventional cardiac assist devices.

Product Matrix

Core Medical was founded inIn August 2016, headquartered in Nanshan District, Shenzhen, Core Medical is a national high-tech enterprise. The founder of the company, Yu Shunzhou, graduated from Harbin Institute of Technology and served as a senior R&D engineer at Terumo Heart, Inc. in the United States. He returned to China in 2016 to establish Shenzhen Core Medical Technology Co., Ltd.

The company's product layout covers the full range of artificial hearts, including implantable and interventional products. The companyCorHeart®6 Implantable Left Ventricular Assist System was approved for marketing in June 2023, being the world's smallest full magnetic suspension artificial heart.

Market Landscape

The evolution of artificial heart technology has gone through three generations, from the initial pulsatile pump to the axial flow pump, and then to the currently most advanced fully magnetically suspended centrifugal pump.Miniaturization, LightweightHas always been the core direction pursued by technology and clinical practice.

Comparison of Different Generations of Artificial Heart Technologies

According to the public academic summit data in the company's prospectus,In 2024 and from January to May 2025, the proportion of Corheart®6 implants during the period accounted for 45.90% and 52.86%, respectively, ranking first in the industry.

Clinical Application

The market size of cardiovascular interventional devices in China is enormous. In the pastIn the past five years, the compound annual growth rate of China's cardiovascular interventional device market has reached 10.2%, and it is expected that the market size will exceed 90 billion yuan by 2026.

However, this market still faces severe challenges. The high-end cardiovascular interventional device market in China remains monopolized by international giants, with Medtronic, Boston Scientific, and others occupying over...60% of the market share.

In high-end fields such as intravascular ultrasound, imported products still dominate.

Competitive Advantage

From the company's perspective, Core Medical has achieved significant results in the field of implantable artificial hearts.In 2024, the market share of its Corheart®6 product in China has exceeded 45%, ranking first in the industry.

In terms of overseas markets,Corheart®6 has obtained marketing approval in Colombia and Ukraine, and the first overseas implantation has been successfully completed in Austria, making Shenzhen Core Medical Technology Co., Ltd the first Chinese company to achieve clinical application of high-risk active implantable devices abroad.

The company is building a product matrix covering the entire cycle of heart failure treatment, demonstrating its determination to compete with global medical giants.

Industry Challenges

The R&D investment in high-end medical devices is enormous, and it takes an average of X years from development to clinical application.Five years, with investment costs reaching tens of millions or even hundreds of millions of yuan. The high cost of innovation and the long transformation cycle pose challenges to enterprises' continuous innovation.

In terms of price, the cost of a single surgery involving interventional high-value consumables often exceeds50,000 yuan, of which the cost of medical devices accounts for more than half.

The mismatch between medical insurance payment standards and the speed of medical device innovation has led to the widespread clinical application of many high-end medical devices with advanced technology being hindered due to their high costs.

Future Layout

Core Medical is simultaneously advancing the layout of its interventional artificial heart product, which is independently developed.CorVad® Interventional Ventricular Assist System entered the Innovative Medical Device Green Channel in July 2023. This series of products has completed multi-center clinical trials and has been submitted to the National Medical Products Administration for registration approval.

The company has currently laid outFive implantable and six interventional artificial heart products, among which one implantable product has been commercialized and two interventional products are in the registration approval stage.

IfCorVad® Series Products Officially Approved: Core Medical Set to Become the World’s Only Company with Commercialized Implantable and Interventional Artificial Heart Products.

As ofBy the first half of 2025, Core Medical has completed a total of six rounds of financing and accumulated 327 patents. The company's product, Corheart®6, has been successfully implanted in more than 36 pediatric patients, demonstrating that miniaturization technology can break through the "adult-to-child" compatibility barrier.

The scale of end-stage heart failure patients in China exceeds one million, while the number of heart transplant surgeries completed each year is less than a thousand. This thousand-fold supply-demand gap is driving the rapid development of artificial heart technology produced in China, providing broad market space for companies like Core Medical.