Fengkaili Medical's Percutaneous Left Ventricular Assist Device and Catheter Pump Kit Receive NMPA Approval

Source: National Medical Products Administration website

Recently, the National Medical Products Administration approved the registration application for ForQaly Medical (Shanghai) Co., Ltd.’s interventional left ventricular assist device and interventional left ventricular assist catheter pump kit.

The interventional left ventricular assist device consists of a control unit, control cables, and a mobile cart; the interventional left ventricular assist catheter pump kit comprises a blood-pumping catheter and an infusion line. Used in combination, they provide left ventricular support for adult patients with severe coronary artery disease, reduced left ventricular ejection fraction, and stable hemodynamics undergoing high-risk percutaneous coronary intervention (PCI).

This product features an extracorporeal motor design connected via a flexible drive shaft to pump blood from the left ventricle into the aorta, providing short-term left ventricular assistance. Its market availability offers patients additional treatment options.

The drug regulatory authorities will strengthen post-market supervision of the aforementioned products to safeguard patient safety in the use of medical devices.