Kekai (Nantong) Life Sciences' Transcatheter Mitral Valve Repair System Receives NMPA Approval
Kokai Life Sciences
Developer, Manufacturer, and Distributor in the Field of Structural Heart Disease
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Recently, the National Medical Products Administration approved the innovative product registration application for the transcatheter mitral valve repair system by Kokai (Nantong) Life Sciences Co., Ltd.
This product is composed of a clip device and delivery system, and a catheter sheath assembly. The clip device and delivery system consist of a clip device, an implant catheter, and a steerable sleeve. The catheter sheath assembly is composed of a catheter sheath and a dilator, with the catheter sheath including a deflectable sheath and a handle. This product is delivered percutaneously and is suitable for patients with degenerative mitral regurgitation (MR≥3+) who are assessed by the heart team as being at high surgical risk and whose mitral valve anatomy is suitable.