China's first artificial hearts greenlighted for sale
Artificial heart demo at the Smart China Expo, Chongqing , 2019 /VCG Photo

Artificial heart demo at the Smart China Expo, Chongqing , 2019 /VCG Photo

After six years development and clinical trials, Eva  Heart, a Chongqing-based company, got authorization from the National Medical Products Administration for their artificial hearts, making it the country's first company to have the implantable ventricular assist device to go on sale, according to the Chongqing Municipal Drug Administration on Tuesday.

The product, known as EvaHeart I, will be about 30 percent cheaper compared to similar foreign counterparts, the company said. Before that, China relied heavily on the imported products from the U.S. and Japan.

European Society of Cardiology data shows over 26 million people worldwide are living with heart failure and half of them are Chinese.

"For patients with severe heart failure, they should either have a heart transplant surgery or an artificial heart," Hu Shengshou, the acting president of Fuwai Hospital Chinese Academy of Medical Sciences explained. However, there are only about 400 heart donations in China every year, which is far from enough.

The implantable ventricular assist system, commonly known as artificial heart, is a prosthetic device that can provide circulation and replace heart ventricles that are diseased or damaged.

"Considering the donor shortage, artificial heart surgery can be an alternative treatment for patients who cannot receive a heart transplant." He also explained the long-term effect of medical treatment for stage IV patients is not satisfying, with the five-year survival rate being only 35 percent.

The whole set of technology has long been held by the U.S., Japan, and some European countries. EvaHeart I is an upgrade version of the Japanese prototype.

In 2018, EvaHeart I started clinical trials. After 15 successful clinical trials without complications and side effects, the product has been rewarded with "Best Clinical Performance Award."