Release date: 2023-11-30
Recently, the China NMPA approved the innovative product registration application for the “Transcatheter Mitral Valve Clamp System” of Hangzhou Dejin Medical Technology Co., Ltd.
This product consists of two components: the guiding sheath and the mitral valve clamp system. Among them, the mitral valve clamp system includes a mitral valve clamp and a delivery system. The elastic central blocking network structure of the mitral valve clamp can increase the clamping sealing, reduce central residual regurgitation, and reduce the leaflet clamping force; at the same time, The mitral valve clamp also has functional designs such as individually capturing leaflets and repeatable positioning and capturing, which can improve operational accuracy and reduce the risk of mitral valve clip detachment and leaflet perforation.
This product is suitable for patients with degenerative mitral regurgitation (MR≥ 3+) who are considered to be at high risk for surgery after evaluation by the heart team and whose mitral valve anatomy is suitable. The launch of this product will provide more options for clinical treatment.
The NMPA will strengthen post-market supervision of this product to protect patient safety.