Yongqi's self-developed heart valve opens the door to the European and American markets

This report (Reporter Shen Sunhui, Correspondent Zhuo Songlei) learned from Qianwan New Area yesterday that the LuX Valve Plus, a catheter based tricuspid valve replacement system independently developed by Ningbo Jianshi Technology Co., Ltd., the first listed unicorn enterprise in Ningbo, has obtained the EU MDR CE certification and successfully obtained the EU market access permit. It is reported that this is also the second approved in situ tricuspid valve replacement device worldwide.
The human heart has four valves, and the tricuspid valve is the "gateway" between the right atrium and the right ventricle. Recently, a popular TV series called "Heart Asking 2" has made many viewers hear about the term "tricuspid valve". The elderly critically ill patients in the drama who undergo open chest valve replacement have significant trauma and a high risk of postoperative infection, and can only be treated conservatively. The doctor in the drama lamented that what is lacking in clinical practice is minimally invasive valve instruments that have less trauma, higher safety, and can adapt to complex anatomical structures.
Seeking medical treatment during the play is difficult, but outside of the play, the situation is disrupted. Jianshi Technology is this disruptor.
Compared to traditional open chest surgery and existing interventional valve products, Jianshi Technology's transcatheter tricuspid valve replacement system has taken a new path. For example, instruments enter the heart through blood vessels without the need for thoracotomy; Adopting a multi-dimensional adjustable bending delivery system is beneficial for precise positioning of valve release during surgery; We offer seven valve size models ranging from 40mm to 70mm, which can cover patients with different anatomical structures
More cutting-edge, Jianshi Technology also allows robots to assist in surgeries. They and the Institute of Automation of the Chinese Academy of Sciences jointly developed a robot assisted transcatheter tricuspid valve replacement system, which enables the instrument to achieve stable, fine and remote control, reduce the complications that may be caused by the slight shaking of doctors' hands and the difference in operating range, improve the accuracy of valve implantation, and shorten the duration of surgery.
It is reported that the LuX Valve series products have completed clinical implantation for over a thousand patients in dozens of countries and regions, filling the clinical treatment gap for patients with tricuspid regurgitation, especially those with complex anatomical structures. Relevant clinical data has been released at multiple top international academic conferences.
Good news came one after another. After obtaining the EU MDR CE certification, Jianshi Technology's transcatheter tricuspid valve replacement system has recently completed the first batch of subject implantation in a critical registration clinical trial approved by the US Food and Drug Administration (FDA). This is a prospective, global multicenter clinical trial covering multiple countries such as the United States and Canada, which means that Jianshi Technology's globalization pace is accelerating.
The Linfeng Medical Industry Park, where Jianshi Technology is located, has created the city's first "shared laboratory" for medical devices, providing high standard testing services for medical technology enterprises. Jianshi Technology's key biological raw material for manufacturing tricuspid valves, bovine pericardium, needs to be imported from New Zealand and stored at low temperatures and transported in a cold chain. The Hangzhou Bay New Area Customs has arranged a dedicated person to ensure quarantine approval, achieving "immediate reporting, immediate review, and immediate approval" to help expedite the clearance of inbound and outbound biological materials
At present, Qianwan New Area has gathered more than 100 high-quality projects in the life and health industry, such as Kanglong Huacheng, Merck Dong Animal Health, and Jianshi Technology, with a total investment of over 32 billion yuan.