China NMPA Approves Innovative Medical Device: Transcatheter Pulmonary Valve System

On October 9, 2026, the National Medical Products Administration of China announced that it has approved the registration application for the innovative product “Transcatheter Pulmonary Valve System” developed by Beijing Balance Medical Technology Co., Ltd.

The product consists of a pulmonary valve and a pulmonary valve delivery system. The pulmonary valve is composed of leaflets, inner covering, sutures, outer covering, and a metal stent. The delivery system includes a delivery device and a loader. This product uses a trans-thoracic small-incision approach and is indicated for patients with severe pulmonary regurgitation after complex congenital heart disease surgery who have a native right ventricular outflow tract (age ≥9 years, weight ≥20 kg).

Patients must be systematically evaluated by a team of cardiologists and cardiac surgeons to confirm an indication for pulmonary valve replacement, have failed medical therapy, be intolerant to conventional surgery, or need to delay the next surgical procedure. In addition, the patient’s condition must be suitable for treatment with this product, and the anatomy must be compatible with the device, such as a main pulmonary artery diameter ≥16 mm and a main pulmonary artery length ≥20 mm, etc.; see the instructions for details. This treatment cannot replace open-heart surgery.

The drug regulatory authority will strengthen post-marketing surveillance of the product to protect patient safety in device use.

As of the approval of this product, the NMPA has cumulatively approved 446 innovative medical devices through the special review procedure for innovative medical devices, covering fields such as life support, advanced imaging, interventional implants, in vitro diagnostics, surgical robots, and AI-assisted diagnosis and treatment. Balance Medical previously had products such as the transcatheter valve-in-valve system and the transcatheter aortic valve system approved, and the approval of this pulmonary valve system further enriches its product portfolio in the field of structural heart disease intervention.