On September 8, the official website of the State Drug Administration (SDA) released information showing that the "Mitral Valve Clamping System" produced by Shanghai Han Yu Medical Technology Co.

The product consists of a mitral valve clip, a delivery system and a transvalve device. Among them, the delivery system consists of a conveyor, a pusher, a loader, a catheter sheath and a dilator. With this product, there is no need for cardiac arrest and extracorporeal circulation during the procedure, small incisions, short surgical access, and direct positioning; and purely ultrasound-guided interventions, making doctors and patients unaffected by X-rays. The mitral valve clip has a large capture range, which is favorable for operation. With the closed ring design, the clip arms are not easy to separate from each other, which ensures a stable clip.

The product uses a transapical surgical approach and is suitable for patients with degenerative mitral regurgitation (MR ≥3+) who are assessed by a specialized cardiac team to be at high risk for surgical intervention and have suitable mitral valve anatomy. The underlying disease in these patients should not interfere with the clinical benefit derived from reduced mitral regurgitation.

At this point, the State Drug Administration has approved a total of 230 innovative medical device products