Recently, the NMPA announced the approval of Core Medical Technology Co., Ltd.'s percutaneous left ventricular assist device and percutaneous left ventricular assist catheter pump kit for marketing.
This system utilizes miniaturized axial motor technology for short-term left ventricular assistance. It represents a domestic首创 technology, filling the technological gap in domestic percutaneous cardiac assist devices.
According to research data from several professional institutions, global sales of percutaneous ventricular assist devices (essentially equivalent to pVAD) are expected to reach RMB 25 billion by 2031, demonstrating enormous growth potential. The current market is largely dominated by imports, with domestic products mostly still in clinical stages. Among international players:
Abiomed (US, a Johnson & Johnson subsidiary): Its Impella series is currently the only large-scale commercialized percutaneous left ventricular catheter pump, holding over 80% market share by both volume and value, effectively enjoying a monopoly position.
Abbott: Strengths lie in implantable LVADs (HeartMate 3), with only short-term peripheral cannulation products in pVAD, holding less than 5% market share.
Medtronic, LivaNova, et al.: Primarily provide ECMO/cardiopulmonary bypass or implantable LVADs, with combined pVAD share below 5%.
The percutaneous left ventricular assist device and percutaneous left ventricular assist catheter pump kit are used together 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 hemodynamic stability.
According to previously disclosed information from Core Medical, the system utilizes self-developed axial flux multi-drive technology, achieving greater flow and more stable performance with a smaller outer diameter, significantly reducing the risk of blood damage, supporting longer clinical use, and demonstrating significant advantages over existing foreign products.
Core Medical's cardiac interventional pump has broken Johnson & Johnson's global monopoly. At the same time, Core Medical is also a leader in the domestic left ventricular assist device market, holding the number one market share. The company is currently advancing toward an IPO on the STAR Market.