NMPA Approves 3 Innovative Medical Devices — Fengkaili SynFlow 3.0 pVAD and Siemens CT System Lead the Way

On June 18, 2026, China's National Medical Products Administration granted marketing authorization to three innovative medical devices, underscoring China's accelerating pace of homegrown innovation in cardiovascular intervention and advanced imaging.

1. SynFlow 3.0 Percutaneous Transvalvular Ventricular Assist System (pVAD)

Manufacturer: Fengkaili Medical Devices (Shanghai) Co., Ltd.

The SynFlow 3.0 is a percutaneous ventricular assist device (pVAD) consisting of two components: an interventional left ventricular assist device (comprising control equipment, control wires, and a mobile cart) and an interventional left ventricular assist catheter pump kit (comprising a blood-pumping catheter and perfusion circuit). The system is indicated for high-risk percutaneous coronary intervention (PCI) in adult patients with severe coronary artery disease, reduced left ventricular ejection fraction, and hemodynamic stability.

Technical breakthrough: The SynFlow 3.0 employs an external motor design connected via a flexible drive shaft, enabling blood pumping from the left ventricle into the aorta for short-term left ventricular support. This approach distinguishes itself from the globally dominant internal motor pVAD paradigm. As the world's only approved motor-separated pVAD, it represents a significant Chinese contribution to the interventional cardiology armamentarium.

2. X-ray Computed Tomography System

Manufacturer: Shanghai Siemens Medical Devices Co., Ltd.

An advanced CT imaging system approved through the innovative device pathway, further expanding China's domestic high-end imaging capabilities.