Today (August 14), according to the NMPA official website, Shanghai NewMed Medical Co., Ltd. "Transcatheter Aortic Valve System" innovative product registration application.

The product is composed of a transcatheter aortic valve, a transcatheter aortic valve delivery system (including a delivery device and a valve loader), an aortic valve balloon dilation catheter, a crimping device, and a balloon inflation device.

The Transcatheter Aortic Valve System is the first domestically produced balloon-expandable transcatheter aortic valve product in China. It is suitable for patients who are assessed by a cardiac team using a scoring system as having symptomatic, calcified, severe degenerative native aortic valve stenosis, are not suitable for conventional surgical valve replacement, and are aged 70 years or older. Under the monitoring of medical imaging equipment, this product is implanted via the femoral artery to the aortic valve annulus, replacing the diseased aortic valve to alleviate the stenosis at the lesion site and improve cardiac function.