One approved, six on the way. Is the pVAD market getting competitive in its first year of launch?

The percutaneous ventricular assist device (pVAD) is finally set to be launched.

In December 2025, the percutaneous ventricular assist device under Core Medical was approved for marketing by the National Medical Products Administration, becoming the first domestically approved product of its kind in China. It can be used for high-risk percutaneous coronary intervention (PCI), providing minimally invasive and convenient left ventricular assistance for adult patients with severe coronary artery disease, reduced left ventricular ejection fraction, and stable hemodynamics. In February 2026, the first post - marketing surgery using this product was successfully carried out, officially marking its entry into the clinical application stage.

Meanwhile, the Impella series of percutaneous ventricular assist devices from Abiomed have also recently been introduced into China through the clinical urgent need channel. Previously, this product entered the green channel for innovative medical devices in 2024.

In addition to Core Medical and Abiomed, more than a dozen domestic enterprises have ventured into the field of percutaneous ventricular assist devices. The core products of several of these enterprises have completed clinical trials or are about to conclude them, and are highly likely to be approved for marketing in 2026.

Judging from this trend, 2026 is expected to be the "year of collective approvals" for percutaneous ventricular assist devices, and the industry will enter a window period for large - scale implementation.

Percutaneous Ventricular Assist Device: A Market with Hundreds of Billions - Level Demand

Why is the market looking forward to percutaneous ventricular assist devices?

Taking the leading enterprise Abiomed as an example, over 95% of its revenue comes from the Impella series of percutaneous ventricular assist device products. Relying solely on this product, Abiomed's revenue exceeded $1 billion in 2022, and it became one of the 14 pharmaceutical stocks that increased ten - fold between 2009 and 2019.

Meanwhile, in 2022, Johnson & Johnson acquired Abiomed at a sky - high price of $16.6 billion (approximately RMB 114.6 billion). The core asset that supported this hundreds - of - billions valuation was precisely the Impella series of percutaneous ventricular assist devices.

Subsequent performance also proved the correctness of Johnson & Johnson's decision. The sales volume of the Impella series of products has been on the rise, and the revenue has been growing steadily: the revenue in fiscal year 2023 was $1.306 billion, in fiscal year 2024 it was $1.496 billion, and in fiscal year 2025 it climbed to $1.751 billion, demonstrating strong growth resilience.

Abiomed's rapid development has also brought substantial returns to Johnson & Johnson. Its second - quarter financial report in 2023 showed that after the acquisition, Abiomed added $660 million in bottom - line earnings to Johnson & Johnson Medical Devices. After the release of the quarterly report, Johnson & Johnson's stock price soared by over 6% in a single day. Throughout 2023, Abiomed's performance exceeded Johnson & Johnson's internal model and the expectations of Wall Street analysts before the completion of the transaction. In fiscal year 2025, driven by Abiomed and electrophysiology products, Johnson & Johnson's cardiovascular business achieved a strong growth of 15.8%, with sales reaching $8.928 billion.

Currently, the clinical application scope of the Impella series of products under Abiomed continues to expand, and they are widely used in scenarios such as the treatment of cardiogenic shock and high - risk PCI (percutaneous coronary intervention). They have been applied in over 400,000 cases globally, and the annual sales have exceeded $1.7 billion, making them a benchmark product in the field of critical cardiovascular diseases.

The core reason why the Impella series can support a hundreds - of - billions valuation, achieve annual revenues in the tens of billions, and accumulate hundreds of thousands of clinical applications is that the market space is large enough. Moreover, previously, it was the only product approved in the global market, enjoying a monopoly. Now, with the approval and launch of domestic percutaneous ventricular assist devices, the structure of this hundreds - of - billions market will be reshaped.

pVAD: The Gold Standard for Short - Term Ventricular Assist Therapy

The percutaneous ventricular assist device is a type of percutaneous ventricular assist device mainly targeting scenarios such as cardiogenic shock and high - risk coronary intervention (PCI), providing medium - to - short - term ventricular circulatory assist therapy for patients with critical cardiovascular diseases.

(The catheter pump body of Core Medical's percutaneous ventricular assist system)

Specifically, when performing surgical treatment on high - risk cardiovascular patients, clinically, the percutaneous ventricular assist device can be inserted into the main blood vessel through the skin and advanced to the heart. The integrated blood pump pumps blood directly from the failing heart into the aorta or pulmonary artery, thereby improving systemic blood flow and the perfusion of vital organs.

There is also an implantable artificial heart on the market. However, the implantable artificial heart is mainly for patients with end - stage heart failure, aiming to help patients improve symptoms, enhance the quality of life, and prolong their lifespan. Different from the percutaneous ventricular assist device, the implantable artificial heart is implanted into the patient's heart through a thoracotomy. It causes greater trauma, has a longer assistance time, is more complex in product design, and incurs higher costs.

Compared with the implantable artificial heart, the percutaneous ventricular assist device corresponds to a broader patient group and has a larger market space. Core Medical's prospectus shows that in 2024, the number of patients with cardiogenic shock in China was 308,000, and the number of PCI surgeries in China reached 1.906 million, of which the proportion of high - risk PCI was about 10 - 15%. The clinical demand is extensive and urgent. According to Frost & Sullivan, it is estimated that the market size of medium - to - short - term artificial hearts in China will exceed RMB 11 billion in 2033, while the market size of implantable artificial hearts is expected to be RMB 5.7 billion in 2033.

It should be noted that in addition to the percutaneous ventricular assist device, percutaneous ventricular assist devices also include products such as the intra - aortic balloon counterpulsation system (IABP) and extracorporeal membrane oxygenation equipment (ECMO).

The intra - aortic balloon counterpulsation system (IABP) is a pulsatile pump assist device that can increase cardiac output by 10% - 20%. It has the advantages of easy insertion and a low complication rate, and is currently a commonly used percutaneous device circulatory assist method in China.

Extracorporeal membrane oxygenation (ECMO) is an extracorporeal life support technology that can significantly increase cardiac output. However, it increases the afterload of the left ventricle, does not significantly increase coronary perfusion, and is complex to operate. It is suitable for emergency situations such as heart failure combined with respiratory failure and cardiac arrest.

The percutaneous ventricular assist device (pVAD), as an innovative medical device highly anticipated by the market, can provide larger flow support such as 2.5 liters, 3.5 liters, and 5 liters. Moreover, this product can reduce the afterload of the left ventricle and effectively improve coronary perfusion.

In comparison, pVAD represented by the Impella system is currently the most widely used and fastest - growing percutaneous ventricular assist device globally. In the field of treating high - risk PCI patients, pVAD has the most comprehensive clinical research evidence, and authoritative guidelines also give clear recommendations.

In 2025, international societies such as the ACC/AHA updated and released the guidelines for the management of patients with acute coronary syndrome (ACS) based on the results of multiple pVAD clinical studies. The guidelines clearly recommend that pVAD is suitable for patients with acute ST - segment elevation myocardial infarction complicated by severe or refractory cardiogenic shock and patients with ACS complicated by mechanical complications who meet the indications. It also points out that for patients with acute myocardial infarction complicated by cardiogenic shock, the routine use of IABP or VA - ECMO is not recommended.

Relying on its excellent clinical effects, clear guideline recommendations, and huge patient demand, the percutaneous ventricular assist device (pVAD) is expected to dominate the future hundreds - of - billions percutaneous ventricular assist market.

Competition in the pVAD Field: Differentiated Innovation Is the Key

Even in the field of percutaneous ventricular assist devices with high technical barriers, more than a dozen domestic enterprises have simultaneously entered the market.

As shown in the above table, the percutaneous ventricular assist devices of domestic enterprises each have their own characteristics. For example, Core Medical's CorVad is designed to provide support for up to 28 days; Xinqing Medical's NyokAssist has a very small intervention size of 9Fr; Fengkaili has innovated the clean perfusion technology; Xinhengrui Medical is equipped with an intelligent design; Xinlingmaide's innovative cassette perfusion is more stable and long - lasting...

It should be noted that in percutaneous ventricular assist devices, a larger flow support is not always better. Instead, it is necessary to combine multiple dimensions such as product size, support time, and filling and sealing technology to provide solutions that meet the needs of corresponding patients. For example, the Impella series of products include multiple models such as Impella CP, Impella 5.0, and Impella 2.5, which can provide maximum flow supports of 3.7L/min, 5L/min, and 2.5L/min respectively to meet the needs of different patients.

The reason why these products have their own characteristics is that different enterprises have adopted different technical routes and achieved technological innovation in different directions. According to the location of the power device, percutaneous ventricular assist devices can be divided into two types: those with an internal motor and those with an external motor.

Among them, enterprises such as Core Medical, Tongling Bionic, Huanqing Medical, and Xinlingmaide have adopted the internal - motor route, while Xinqing Medical, Fengkaili, and Anlande have adopted the external - motor route.

The principle of the internal - motor route is as follows: The impeller and micro - motor of the percutaneous ventricular assist device are sent to the ascending aorta through the femoral artery; the catheter is sent to the left ventricle, with the inflow port of the catheter located in the left ventricular outflow tract and the outflow port located in the ascending aorta. When the micro - axial flow pump at the catheter tip operates, the catheter sucks blood out of the left ventricle and transports it to the ascending aorta.

Since the motor is placed inside the body in this route, enterprises need to overcome technologies such as micro - motors. Moreover, because the motor is close to the impeller, the power transmission efficiency is higher, the damage to the myocardium and heart valves is smaller, the fluid is more stable, there is less eddy current, the damage to blood cells is small, the risk of hemolysis and tissue damage is low, and it is more conducive to long - term stable operation in the body. This is also the key reason why Core Medical's CorVad can provide support for up to 28 days.

Previously, Core Medical, which chose the internal - motor technical route, released the clinical research results of CorVad. Clinical data showed that the CorVad system was successfully placed in 118 (100%) high - risk PCI patients, and no hemodynamic impairment occurred in all patients. The operation was successful in 116 (98.3%) patients, and acute kidney injury occurred in 14 (11.9%) patients. There were no cases of severe hemolysis, device failure, or life - threatening infections. Compared with the baseline, the left ventricular ejection fraction was significantly increased at 48 hours, before discharge, and 30 days after PCI.

Core Medical also conducted a randomized controlled study comparing CorVad with ECMO. The data showed that the incidence of adverse events at 30 days was 15.0% in the CorVad group and 29.1% in the ECMO group; at 90 days, the incidence of adverse events was 15.8% in the CorVad group and 33.9% in the ECMO group. This indicates that for pVAD intraoperative support in high - risk PCI, CorVad is non - inferior and superior to ECMO in terms of adverse events at 30 days and 90 days.

In addition to Core Medical, the classic Impella series of products with over 400,000 applications in the market also use the internal - motor route, which has been widely verified clinically.

The principle of the external - motor route is as follows: The impeller of the percutaneous ventricular assist device is placed in the left ventricle, and the power device (motor) is placed outside the femoral artery (outside the body). The power device and the impeller are connected by a flexible drive shaft. When the device operates, the catheter sucks blood from the left ventricle into the aorta. Since the motor is placed outside the body in this technical route, the (motor) cost is significantly reduced, and the size of the percutaneous ventricular assist device is reduced. For example, Xinqing Medical uses the external - motor route, and the size of its NyokAssist is 9Fr, smaller than the 14Fr of the Impella series.

However, since the motor is placed outside the body, such products require a larger impeller to generate sufficient flow support and a reliable drive shaft to connect the power device and the impeller. This requires enterprises to overcome technologies such as foldable impellers and flexible drive shafts.

Although not widely used clinically yet, products of this technical route have also achieved excellent results in clinical research. Taking Fengkaili as an example, the randomized controlled study data of its SynFlow 3.0 percutaneous trans - valve micro - axial flow pump showed that 7.34% of the SynFlow 3.0 group had major adverse events at 30 days, while 11.5% of the ECMO group had major adverse events, reaching the significance level of the non - inferiority test, indicating that the SynFlow 3.0 group is non - inferior to ECMO and can be used as an option for pVAD in high - risk PCI patients. Moreover, compared with ECMO, SynFlow 3.0 is associated with less intraoperative blood transfusion, shorter hospital stays, and fewer device - related adverse events.

In addition to the difference in the location of the power device, enterprises also differ in terms of blood flow support. In the market, most enterprises choose micro - axial flow pumps similar to those in the Impella series of products to provide patients with continuous and stable circulatory support.

Another group of enterprises chooses pulsatile pumps. This is because research has found that the cardiac blood circulation has pulsatile characteristics, and pulsatile blood pumping is more in line with the body's physiological circulation mechanism, can better simulate physiological blood perfusion, and improve the efficiency of blood flow support.

In response, Yuewei Medical has launched a pulsatile percutaneous left ventricular assist device; Maikes Medical's Pulsevad percutaneous ventricular assist device uses a pulsatile design; Huanqing Medical's Huanmei percutaneous left ventricular assist system is equipped with a bionic adaptive pulsatile flow assist function... At the same time, these innovative pulsatile artificial hearts have also achieved a small catheter diameter and relatively large blood flow support. For example, Maikes Medical's PulseVAD has a catheter diameter of less than 14Fr.

Overall, there are more than 10 domestic percutaneous ventricular assist devices. In the future, which one will take the lead in the market remains to be tested by the market and clinical practice.

The 7 Fastest - Developing Domestic Percutaneous Ventricular Assist Devices

Based on the progress of these more than ten percutaneous ventricular assist devices, the 7 fastest - developing domestic percutaneous ventricular assist devices are summarized.