Health

The transcatheter tricuspid valve ring shaping system has been approved for market launch

2025-03-14   

According to the website of the National Medical Products Administration, the administration has recently approved the registration application for the innovative product of Shanghai Huihe Medical Technology Co., Ltd.'s transcatheter tricuspid valve ring shaping system. The transcatheter tricuspid annuloplasty system includes a tricuspid annulus clamping system and a delivery sheath kit, wherein the tricuspid annulus clamping system includes a clamping component, an anchor component, and a delivery system, and the delivery sheath kit includes a delivery sheath and a dilator. This product is used to alleviate clinical symptoms of tricuspid regurgitation and heart failure in patients. Suitable for isolated severe tricuspid regurgitation with non severe annular or right ventricular dilation and clinical symptoms of right heart failure that do not require simultaneous left valve surgery; A high-risk contraindication patient over 65 years old who has no severe pulmonary arterial hypertension, no severe right/left ventricular systolic dysfunction, and has undergone guideline guided drug treatment for more than 30 days with poor drug treatment efficacy, and has been assessed by the cardiac team as unsuitable for surgical intervention. The drug regulatory authorities will strengthen post market supervision of the product to protect the safety of patients using the device. (New Society)

Edit:Ou Xiaoling Responsible editor:Shu Hua

Source:People Net

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