
Artificial Heart Series Product Developer
Source: Website of the National Medical Products Administration
Recently, the National Medical Products Administration approved the registration application for the interventional left ventricular assist device and the interventional left ventricular assist catheter pump kit from Shenzhen Core Medical Technology Co., Ltd.
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.
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.
The drug regulatory department will strengthen the post-marketing supervision of the aforementioned products to ensure patient safety in medical device usage.