Breaking news has just emerged from the artificial heart sector. According to the official website of the National Medical Products Administration (NMPA), CoreMedik’s Interventional Left Ventricular Assist Device and Interventional Left Ventricular Assist Catheter Pump Kit have obtained approval for marketing. This is not only China’s first domestically-developed interventional artificial heart product to secure marketing approval, but also makes CoreMedik the world’s sole enterprise holding regulatory approvals for both implantable and interventional artificial hearts simultaneously. It marks that China’s domestic artificial heart technology has officially joined the world’s leading ranks, bringing a lifeline to a vast number of high-risk cardiovascular disease patients.
The NMPA commented: "This system adopts miniaturized axial motor technology for short-term left ventricular support. As an innovative domestic technology, it fills the gap in interventional cardiac assist device technology in China."

Homegrown "Life Pumps" End Overseas Technological Hegemony

Homegrown "Life Pumps" End Overseas Technological HegemonyThe approval of CorVad® marks a pivotal breakthrough for China’s high-end medical devices in a bottleneck field. As a critical support for treating severe and acute cardiovascular diseases, percutaneous ventricular assist devices have long been monopolized by Impella, a product under Johnson & Johnson. In 2022, Johnson & Johnson acquired Abiomed—the developer of Impella—for a whopping $16.6 billion, setting the largest acquisition record in the company’s history and underscoring the strategic value of this sector.
Data shows that the Impella series has been applied in over 400,000 clinical cases worldwide, with annual sales reaching nearly $1.5 billion. A Frost & Sullivan survey of U.S. physicians indicates that 64% of American cardiologists use Impella® in high-risk PCI procedures, while the utilization rate of the traditional IABP has shrunk to 28%. This high adoption stems from the particularity of high-risk PCI: even transient circulatory fluctuations during surgery may quickly spiral into a vicious cycle due to reduced cardiac output and decreased coronary perfusion pressure, leading to acute heart failure or circulatory collapse that threatens life. Percutaneous ventricular assist devices can maintain intraoperative hemodynamic stability, playing a crucial role in lowering surgical risks and improving prognosis. Prior to this, China lacked approved domestic alternatives, leaving patients with severe and acute conditions facing a dilemma of having no available devices.
CorHeal Medical’s breakthrough has completely reversed this situation. The CorVad® series is an original product independently developed by the company, adopting the world’s pioneering intravascular miniaturized "axial flux multi-drive motor technology" to reduce the motor diameter to 4-5 millimeters and realize a built-in motor design—meaning the motor is implanted inside human blood vessels. This design shortens the transmission distance between the motor and impeller, minimizes pump vibration during high-speed impeller rotation, boosts operational reliability, and effectively reduces risks of hemolysis and other blood compatibility issues as well as tissue damage. In addition, the internal motor and short rigid shaft transmission inside the body are less affected by external interference, enabling more accurate monitoring of pump blood flow and rotational speed. The multi-drive axial motor design with higher magnetic flux density significantly increases motor magnetic flux density, improves overall motor efficiency, and achieves higher pump blood flow. The built-in ultra-miniature pressure sensor further enables precise hemodynamic monitoring, providing data support for personalized treatment.
Known as the "miniature factory in blood vessels", percutaneous ventricular assist devices require overcoming multiple technical barriers including motor miniaturization, blood compatibility and long-term reliability. Compared with traditional auxiliary devices and international competitors, CorVad® has achieved comprehensive upgrades in core performance.
In terms of blood compatibility — a top clinical concern — CorVad® demonstrates overwhelming advantages. The special rigid shaft driven by the axial flux motor significantly reduces friction contact area and heat generation, with the pump surface temperature rise less than 2℃ even at maximum speed. Meanwhile, the streamlined low-shear impeller and precision manufacturing ensure stability during high-speed rotation, avoiding bearing vibration, reducing blood shear stress and minimizing blood damage substantially. In vitro hemolysis tests show that compared with international counterparts Impella® CP and Impella®5.5, CorVad®’s MIH (Modified Index of Hemolysis) is nearly 95% lower, which means patients face significantly reduced risks of severe complications such as bleeding and hemolysis.

Full-Cycle Layout to Build a Comprehensive Heart Failure Treatment System

CorVad® secured regulatory approval in less than two and a half years from entering the innovation pathway, well ahead of the "expected Q1 2026 launch" disclosed in its prospectus. This milestone reflects the combined power of Shenzhen speed and national innovation policies. Beyond the success of a single product, CorVad®’s approval marks that CorHeal Medical has built a comprehensive heart failure treatment system covering short-term emergency care, medium-term transition and long-term support. Its full portfolio integrating implantable and percutaneous devices is unparalleled worldwide.Heart failure treatment is a continuous process: some patients need percutaneous ventricular assist devices (PVAD) for emergency rescue during acute episodes, and may require long-term support from left ventricular assist devices (LVAD) after stabilization. A complete product layout enables seamless care transition.
Previously, CorHeal Medical’s Corheart®6 fully magnetically levitated implantable artificial heart obtained approval in June 2023. As the world’s smallest and lightest commercial fully magnetically levitated implantable artificial heart to date, it captured over 45% of China’s market share in 2024, ranking first in the industry. Leveraging accumulated technologies, channels and brand strengths in implantable artificial hearts, CorHeal is poised to accelerate the clinical rollout of its percutaneous product and unlock China’s high-potential short-to-medium-term artificial heart market.
Frost & Sullivan data shows that the global volume of high-risk PCI procedures reached 2.217 million in 2024, with a 12.1% CAGR from 2019 to 2024; it is projected to hit 5.571 million by 2033, representing a 10.8% CAGR between 2024 and 2033. In China, 1.906 million PCI procedures were performed in 2024, including 193,000 high-risk cases. By 2033, China’s PCI volume is expected to rise to 5.961 million, with high-risk PCI surging to 772,000, a robust 16.7% CAGR for the 2024-2033 period.
Strong clinical demand is driving explosive market growth. Frost & Sullivan figures indicate the global short-to-medium-term artificial heart market expanded from $0.97 billion in 2019 to $2.07 billion in 2024, a 16.4% CAGR. It is forecast to reach $9.82 billion by 2033, growing at an 18.9% CAGR from 2024 to 2033. Domestically, with CorVad® pioneering the market, China’s short-to-medium-term artificial heart market is expected to reach RMB 11.46 billion by 2033, boasting an extraordinary 222.9% CAGR for 2024-2033. Armed with core technological advantages, CorHeal Medical is well-positioned to capture significant shares in both Chinese and global markets.

Industry Milestone: China Smart Manufacturing Leads Global High-End Healthcare

The approval of the CorVad® product series not only brings new hope to numerous heart failure patients but also marks a milestone for the development of China’s high-end medical device industry. Hailed as the "crown jewel of medical devices", artificial hearts involve interdisciplinary integration of mechanical engineering, materials science and biomedical engineering, posing extreme R&D challenges. CorHeal Medical’s success proves that Chinese enterprises now possess full-chain technological breakthrough capabilities spanning motor design, materials R&D and precision manufacturing, breaking the technological monopoly of overseas companies in the high-end medical equipment sector.
Founded in Shenzhen in 2016, CorHeal Medical focuses on the R&D and industrialization of artificial hearts. A number of its products have been included in China’s Innovative Medical Device Special Review Program, ranking first in the artificial heart field in terms of the number of listed products. At present, the company has laid out 5 implantable and 6 percutaneous artificial heart products, achieving full coverage of clinical needs spanning "long-to-short-term support, left-to-biventricular support, and pediatric-to-adult support". Among them, Corheart®6 fully magnetically levitated implantable artificial heart, as the company’s first core commercial product, not only earns the title of "the world’s smallest and lightest" but also stands as China’s first implantable artificial heart approved for clinical treatment of pediatric heart failure, filling the gap in domestic pediatric heart failure therapy and winning the "Important Medical Achievements of 21st Century China" awarded by the Chinese Academy of Medical Sciences. DuoCor®2, an implantable artificial heart still in clinical phase, is a First-in-Class product, expected to become the world’s first approved magnetically levitated integrated implantable biventricular assist device, addressing the global challenge of long-term treatment for biventricular heart failure.
Backed by solid technological strength, Corheart®6 has successfully gone global. In May 2024, CorHeal Medical launched the product’s clinical trials in Europe and completed patient enrollment smoothly; in the same period, the company accelerated its global layout and expanded market presence across multiple countries and regions. In June 2025, Corheart®6 made its debut in the Americas, obtaining market access approval in Colombia and successfully completing the first overseas commercial implantation of a homegrown artificial heart, achieving a historic breakthrough in breaking overseas monopolies with China-made artificial hearts. Looking ahead, as the world’s only enterprise holding regulatory approvals for both implantable and percutaneous artificial hearts, CorHeal Medical is poised to bring China’s smart-manufactured life pumps to benefit more heart failure patients worldwide.