CFDA Approves Novel Heart Valve Replacement Device

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CFDA Approves Novel Heart Valve Replacement Device

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China’s Food and Drug Administration has approved a new-generation heart valve replacement product, which greatly reduces surgery time and increases survival rate.

 

The J-Valve, an upgraded transcatheter aortic valve implantation (TAVI) system developed by JC Medical, has passed clinical tests and will be put into use across China. Traditional TAVI solutions require doctors to make a big incision on the patients’ chests and open their hearts to put the prosthetic valve inside manually, which takes about four hours and poses risks of wrong positioning of valve and loss of blood. The J-Valve system, featuring minimally invasive surgery, is easier to implant and provides automatic positioning of the valve. Doctors only watch an electronic screen and operate outside the patients’ bodies. The whole procedure lasts about 10 minutes.

 

Most prosthetic valves currently available are designed for calcified valves, or aortic stenosis, but the J-valve is a solution to both aortic stenosis and aortic insufficiency, said Guo Yingqiang, a cardiac surgeon at West China Hospital of Sichuan University. The new product was used to fix the hearts of more than 100 patients during the clinical phase. In February 2016, doctors at St. Paul’s Hospital in Vancouver, Canada, succeeded in repairing a patient’s heart using the J-valve. Six implants based on J-valve have been performed in Canada. The aortic valve carries blood out of the heart to the rest of the body. Malfunction of the valve can lead to cardiac failure.

 

An estimated 12 million people worldwide have heart valve diseases, of whom about 2 million live in China.


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