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"Made in Chongqing" Artificial Hearts to Be Officially Used

By RUI HUTAN, KAILONGICHONGQING|Sep 14,2020

On September 8, President Zhang Benyan of Chongqing EVAHEART Medical Devices Co., Ltd received a certificate issued by the Chinese Academy of Medical Sciences (CAMS)– The company’s “Home-made ‘Artificial Heart’ Makes Breakthrough” was selected into China’s Major Medical Progress in 2019 (Department of Biomedical Engineering and Information Science).

The artificial heart made by EVAHEART, named “implanted ventriculus sinister auxiliary system”, was approved to come into the market by the state in August last year, the first batch of approved artificial heart products made in China. According to Zhang Benyan, the product is planned to be used at Sichuan Provincial People’s Hospital this month for the first home-made artificial heart implantation operation in China, marking that the home-made artificial heart will be officially used for clinical purpose.

The artificial heart is known as “a jewel on the crown of medical devices”. EVAHEART artificial heart is mainly composed of an internal blood pump (including pump cable) and artificial blood vessels, and an external controller. The main function is to build auxiliary flow channels for the patient’s heart: Blood flows from ventriculus sinister into the blood pump via incoming blood vessels; the centrifugal force produced by the rotation of the impeller in the blood pump pushes blood out of the blood pump into the ascending aorta via outgoing blood vessels to assist the patient’s blood circulation.

“The artificial heart is technically demanding,” said Liu Yihai, Product R&D Director of EVAHEART. The most difficult is that the blood pump cannot stop for a moment or emit heat or vibrate, and have good biocompatibility. Otherwise, it will endanger the life of the patient.

“Our product is the result of cross-border cooperation.” Speaking of artificial heart, 76-year-old Zhang Benyan became excited.

In 2014, LI-LONG TECHNOLOGY (Chongqing)– the parent company of EVAHEART– initiated the EVAHEART artificial heart project with the world’s cutting-edge medical technology and process on the basis of 20 years of cooperation with Japan’s giant of vehicle control cable system– HI-LEX Group.

“So far, EVAHEART has introduced a full set of artificial heart product design, production technology, and quality management system.” Zhang Benyan said that in January 2018, EVAHEART artificial hearts received clinical trials at Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, and others. As of August 2019, 15 clinical implantation surgeries had been carried out. The patients recovered smoothly after the operation, achieving “zero death and no device-related serious complications”. The success rate of clinical trials reached 100%, so EVAHEART artificial hearts got approved in advance to come into the market.

Hu Shengshou, an academician of the Chinese Academy of Engineering and President of CAMS Fuwai Hospital, said in an interview that there are a large number of heart failure patients in China and that patients in the terminal stage or with severe heart failure can only regain their health through heart transplantation or installation of an artificial heart. Artificial heart overcomes the problem of insufficient donations and is a powerful “weapon” for the treatment of heart failure.

“We are introducing small-sized, lightweight second-generation products that are suitable for all heart failure patients.” Zhang Benyan stressed that EVAHEART will gradually realize the domestication of artificial hearts and reduce the price of artificial hearts to benefit more patients.

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