Shanghai Hanyu Medical's Mitral Valve Clip System Receives NMPA Approval

Recently, the National Medical Products Administration (NMPA) approved the registration of the innovative product "Mitral Valve Clip System" produced by Shanghai Hanyu Medical Technology Co., Ltd. after review.

 

The product consists of a mitral clip, a delivery system, and a transvalvular device. Among these, the delivery system is composed of a delivery catheter, a pusher, a loader, a catheter sheath, and a dilator. Using this product, there is no need forHeartWith cardiac arrest and extracorporeal circulation, the incision is small, the surgical approach is short, and the positioning is direct. Moreover, the use of pure ultrasound guidance for the intervention ensures that neither the doctor nor the patient is affected by X-rays. The mitral valve clip has a large capture range, which is beneficial for operation; it adopts a closed-loop design, making it difficult for the clip arms to separate, ensuring a secure grip.

 

This product is designed for use in transapical procedures and is suitable for patients with degenerative mitral regurgitation (MR≥3+) who have been assessed by a professional cardiac team as having a high surgical risk and whose mitral valve anatomy is appropriate. These patients typically have underlying...DiseaseShould not affect the clinical benefits brought by the reduction of mitral regurgitation. The product's market launch will provide more options for clinical treatment.

 

　　MedicineThe regulatory authority will strengthen the post-market supervision of this product to ensure the safety of patients using the device.