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Artificial heart gets green light to go on market

By YANG CHENG in Tianjin | China Daily | Updated: 2022-07-18 09:37

HeartCon, which features an artificial blood pump, is China's first implantable left ventricular assist device. CHINA DAILY

When the popular TV series Dr. Tang, featuring a made-in-China artificial heart, ended in mid-July, an artificial heart with the combination of domestic rocket and medical technologies was coincidentally approved by national medical product authorities and went on the market.

The implantable left ventricular assist device, named HeartCon or "rocket heart" and independently developed and produced by Rocor Medical Technology Co, was approved by the National Medical Products Administration to enter the market on Wednesday.

HeartCon is the country's first implantable left ventricular assist device with magneto hydrodynamic levitation technologies, according to the website of the administration.

In addition, the device was the first domestically made artificial heart in China to have successfully completed 50 cases of clinical trials and fully meet the clinical trial requirements and regulations set by the administration, TEDA International Cardiovascular Hospital in Tianjin said in a news release.

Liu Xiaocheng, the hospital's president and chief researcher of the clinical trial program, said that teams from the hospital and the China Academy of Launch Vehicle Technology, the country's leading rocket maker, had been working together on the project for the past 13 years.

"This purely domestic artificial heart is expected to end the story that China is unable to treat advanced heart failure, and is good news for Chinese patients with severe heart failure," Liu said.

According to Liu, such devices are the most effective form of treatment following heart transplants, and are widely used in Europe and the United States.

In short, the device is an artificial blood pump, which works in parallel with the heart. It takes over the function of ventricular ejection, by pumping blood into the arterial system, and can partially or completely replace the heart.

Clinical trials of the artificial heart were launched in September 2020, giving more than 50 patients with advanced heart failure a second chance of life.

Bao Xin, 21, was one of the 50 patients to receive an artificial heart.

She said, "I struggled with a kind of myocardiopathy, which was diagnosed when I was 18, and the artificial heart which I received in June 2021 has saved me. … I am living well and happily as a normal person at present. And I receive regular medical checks."

The 2021 Annual Report on Cardiovascular Health and Diseases in China, which was released in late June, estimated that some 8.9 million people in China suffer from heart failure annually.

From September 2020 to August 2021, the National Medical Products Administration approved 68 medical devices to enter its "innovative medical device evaluation channel", including 58 that have originated in China, the report said.

Before the HeartCon, two other artificial heart products had been approved by the administration to go on the market.

In September 2019, the Evaheart, manufactured by the Chongqing Yongrenxin Medical Instrument Co Ltd with Japanese hydrodynamic levitation technology, was approved by the administration.

In November 2021, CH-VAD, made by Suzhou Tongxin Medical Equipment, which has domestic magnetic levitation technology, was approved by the administration.

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