Home China's First Domestic pVAD Receives NMPA Approval as CoreHeart Medical Advances Toward STAR Market IPO

China's First Domestic pVAD Receives NMPA Approval as CoreHeart Medical Advances Toward STAR Market IPO

Dec 24, 2025 18:04 CST Updated 18:04
Johnson & Johnson

Medical Device R&D and Manufacturer

Abiomed

Cardiac System Medical Device Developer

Abbott

Diagnostic and pharmaceutical product manufacturers

Medtronic

Chronic Disease Medical Device and Therapy Developer

LivaNova

Medical Device Supplier

Recently, the NMPA announced the approval of Shenzhen Core Medical Technology Co., Ltd.'s interventional left ventricular assist device and interventional left ventricular assist catheter pump kit for marketing.

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 produced interventional cardiac assist devices.

国产首款pvad获NMPA批准上市 | 锋投动态国产首款pvad获NMPA批准上市 | 锋投动态


国产首款pvad获NMPA批准上市 | 锋投动态


According to research data from some professional institutions: By 2031, the global sales of interventional ventricular assist devices (basically equivalent to pVAD) are expected to reach 25 billion RMB, showing huge growth potential. Currently, the entire market is basically monopolized by imports, with domestically produced products mostly in the clinical stage. Among them: Abiomed (USA, under Johnson & Johnson): The main product is the Impella series, which is currently the only large-scale commercialized interventional left ventricular catheter pump, accounting for over 80% by sales volume/revenue, holding a de facto monopoly position; Abbott: Its strength lies in implantable LVAD (HeartMate 3), with pVAD having only short-term peripheral cannula products, market share < 5%; Medtronic, LivaNova, etc.: mainly providing ECMO/extracorporeal circulation or implanted LVAD, combined pVAD share < 5%.

Summary of Progress of Major Manufacturers of Interventional Left Ventricular Assist Catheter Pumps in China and Abroad

国产首款pvad获NMPA批准上市 | 锋投动态

(As of 2025-12)

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.
According to the information previously disclosed by Core Medical:This system adopts independently developed axial magnetic flux multi-drive technology, achieving greater flow and more stable performance with a smaller outer diameter, significantly reducing the risk of blood damage, and supporting longer clinical use. Compared with existing foreign products, it has significant advantages.
国产首款pvad获NMPA批准上市 | 锋投动态国产首款pvad获NMPA批准上市 | 锋投动态
Core Medical's Heart Intervention Pump Launches, Breaking Johnson & Johnson's Global Monopoly. MeanwhileCore Medical is also the leader of left ventricular assist devices in China, with the highest market share for its products.。The company is currently striving for an IPO on the STAR Market.

国产首款pvad获NMPA批准上市 | 锋投动态