Recently, the innovative product "Prizvalve® Transcatheter Aortic Valve System" of Shanghai NewMed Medical Co., Ltd. is approved by China NMPA.

This product consists of a transcatheter aortic valve, a transcatheter aortic valve delivery system (including a delivery device and a valve loader), an aortic valve balloon dilatation catheter, a crimping device, and a balloon inflation device.

The Prizvalve® Transcatheter Aortic Valve System is the first domestically produced balloon-expandable transcatheter aortic valve product. It is indicated for patients with symptomatic, calcified, severe degenerative aortic valve stenosis who are evaluated by a heart team and deemed unsuitable for conventional surgical valve replacement, and who are 70 years of age or older. Under the guidance of medical imaging equipment, the product is implanted through the femoral artery into the aortic annulus, replacing the diseased aortic valve and improving the stenosis at the affected site, thereby enhancing cardiac function.

The NMPA will strengthen the post-marketing surveillance of the product to protect the safety of medical devices used by patients.