Home> Regulatory Information

Transcatheter Mitral Valve Clip System Approved for Marketing

CCFDIE| Updated: 2025-06-11

     

Recently, the innovative product Transcatheter Mitral Valve Clip System of Hangzhou Dawneo Medical Technology Co., Ltd. is approved by China NMPA.

This product is indicated for patients with degenerative mitral regurgitation (MR ≥ 3+) who are assessed by a heart team to be at high surgical risk and have suitable mitral valve anatomy for the procedure. The product features a wrapped and supportive closed configuration designed to ensure stable anchoring post-implantation. Its four-channel control system for anchoring components allows for either simultaneous or independent leaflet grasping, which is expected to enhance procedural success rates and reduce surgical risks.

The NMPA will strengthen the post-marketing surveillance of the product to ensure the safe use of this medical device.