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Transcatheter Mitral Valve Repair System Approved for Marketing

CCFDIE| Updated: 2023-11-30

Recently, the innovative product Transcatheter Mitral Valve Repair System of Hangzhou Valgen MedTech Co., Ltd. is approved by China NMPA.

This product consists of two components including a guide sheath and a mitral valve clamping system. Among them, the mitral valve clamping system includes a mitral valve clamp and a delivery system. The elastic center sealing network structure of the mitral valve clamp can increase the sealing performance, reduce residual leaflets at the center, and reduce the clamping force of the valve leaflets; At the same time, the mitral valve clamp also has functions such as individual capture of valve leaflets and repeated positioning capture, which can improve operational accuracy and reduce the risk of mitral valve clamp detachment and valve leaflet perforation.

This product is suitable for patients with degenerative mitral regurgitation (MR≥3+) who have been assessed by the cardiac team as having a high risk of surgical intervention and have a suitable anatomical structure of the mitral valve. The launch of this product will provide more options for clinical treatment.

The NMPA will strengthen the post-marketing surveillance of the product to protect the safety of medical devices used by patients.