Ningbo firm wins EU approval for innovative heart valve replacement system

The transcatheter tricuspid valve replacement system. [Photo/Tide News]

A medical technology company in Ningbo has achieved a major milestone, with its self-developed transcatheter tricuspid valve replacement (TTVR) system, LuX-Valve Plus, receiving the European Union's MDR CE certification, opening the door to the European market. The device is only the second TTVR system in the world to gain commercial approval.

Developed by Jenscare Scientific, the minimally invasive system is designed to treat severe tricuspid regurgitation, a heart valve disease that is often difficult to manage with conventional open-heart surgery, particularly for elderly patients or those with complex anatomy.

Compared with traditional procedures, the implantation of LuX-Valve Plus through blood vessels reduces surgical trauma and shortens recovery time. Its innovative ventricular septal anchoring design does not rely on radial force, helping lower the risk of pacemaker implantation while supporting right heart remodeling. The system also features an adaptive sealing skirt to reduce leakage, a flexible delivery system for precise positioning, and seven valve sizes to meet a wide range of clinical needs.

The company has also partnered with the Institute of Automation of the Chinese Academy of Sciences to develop a robotic-assisted TTVR system that combines intelligent navigation, precision motion control, and active safety technologies, improving implantation accuracy and reducing procedure time.

The LuX-Valve series has been implanted in more than 1,000 patients across dozens of countries and regions. Clinical studies conducted in China, Europe, and North America have demonstrated its safety and effectiveness, with patients showing significant improvements in heart function and quality of life.

The achievement also reflects Ningbo's growing life sciences ecosystem. The city's shared medical device laboratory, streamlined testing services, and efficient customs support for imported biological materials have helped local medical technology companies accelerate innovation and expand into global markets.