Jinshi Biotech's Transcatheter Aortic Valve System Receives NMPA Approval

Recently, the National Medical Products Administration approved the innovative product registration application for the "Transcatheter Aortic Valve System" by Kingstron Bio (Changshu) Co., Ltd.

This product is suitable for patients assessed by the cardiac team as unable to tolerate the waiting time for conventional transcatheter aortic valve preloading, and who, after evaluation by the cardiac team using a scoring system, are considered to have symptomatic, calcified, severe degenerative native aortic valve stenosis, unsuitable for conventional surgical valve replacement, and aged ≥70 years. This product is a preloaded, retrievable transcatheter aortic valve system made using a dry valve process, which enhances clinical convenience while reducing the risk of leaflet deformation caused by prolonged compression.

The drug regulatory department will strengthen the post-marketing supervision of this product to protect the safety of patients using the device.