Yingmai Medical's Transcatheter Mitral Valve Clip System Receives NMPA Approval

(Source: China Food and Drug Administration Network)

Recently, the National Medical Products Administration approved the innovative product registration application for the transcatheter mitral valve clip system by Enlight Medical Limited (Shanghai).

The product consists of a mitral clip and catheter delivery system, and a steerable guiding catheter. The mitral clip and catheter delivery system is composed of a mitral clip, delivery catheter, and steerable sheath. The materials of the mitral clip components include cobalt-chromium alloy, nickel-titanium alloy, titanium alloy, pure titanium, and PET. The steerable guiding catheter consists of a guiding catheter, dilator, locking screw, and silicone pad. The mitral clip and catheter delivery system are divided into Type I and Type II catheter delivery systems based on the function of synchronous control or independent control of the clip. The steerable guiding catheter is divided into Type I and Type II steerable guiding catheters according to handle differences. This product is delivered percutaneously and is suitable for patients with degenerative mitral regurgitation (MR≥3+) who are considered high-risk for surgical procedures by the cardiac team and whose mitral valve anatomy is appropriate.

The drug regulatory department will strengthen the post-marketing supervision of this product to protect the safety of patients using medical devices.