NMPA Approves Two Innovative Medical Devices: A Breakthrough for Rare Disease and a Domestic-First Cardiac Intervention Technology

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) to provide left ventricular assistance for 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.

This product, consisting of a main unit, a junction box, disposable electrode pads, a power adapter, a lithium-ion battery, and a charging dock, generates an alternating electric field at a fixed frequency to act on the brain. It is suitable for patients aged 22 years or older with newly diagnosed supratentorial glioblastoma via histopathology or imaging, and is used in combination with temozolomide (TMZ) after surgical and radiation therapy. As the first domestically produced product in China for the treatment of this rare disease, it is expected to improve the accessibility of treatment for patients.