Shanghai Shenqi Medical's Transcatheter Mitral Valve Clip System Approved as Innovative Device; Files for IPO

This product consists of a mitral clip and delivery system, as well as a guidance system. The leaflets can be independently captured, and the delivery system is capable of multi-directional bending. The product is delivered percutaneously and is suitable for patients with degenerative mitral regurgitation (MR≥3+) who are assessed by a cardiac team as having a high surgical risk and whose mitral valve anatomy is appropriate. The underlying conditions of these patients should not affect the clinical benefits achieved by reducing mitral regurgitation. Members of this type of cardiac team must include a cardiac surgeon experienced in mitral valve surgery and a heart disease specialist experienced in treating mitral valve disease. The product is to be used by clinicians trained in interventional cardiac catheterization techniques (including transseptal puncture) and specifically trained in the correct use of this device system, with the support of a cardiac ultrasound specialist.