By Jieyu Wang, Editor

On September 10, Chongqing Economic and Information Technology Commission and Chongqing Municipal Drug Administration held a press conference to announce that the Chongqing-made implantable left ventricular assist system EVAHEART I (Yongrenxin artificial heart) developed and produced by Chongqing Yongrenxin Medical Instrument Co., Ltd. had been approved for registration and to be on the market by National Medical Products Administration. It is the first approved domestic artificial heart product, and its price in the market will be about 30% cheaper than that of similar foreign products.

Technicians of Yongrenxin Medical Instrument Co., Ltd are in strict accordance with the process of production in "Artificial heart" production workshop.

Data show that China accounts for half of the world’s 26 million patients with heart failure, including about 700,000 patients with severe heart failure. For patients with acute heart failure, heart transplantation is the best treatment method. However, due to the shortage of donors, only about 400 heart transplantation operations can be carried out in China every year, which is far from meeting the need.

To aid more patients with heart failure restoring health, the medical community actively develops and studies the ventricular assist system, commonly known as artificial heart, mainly using biological, mechanical means to wholly or partially replace the blood-pumping function of the heart to maintain human blood circulation. Before then, only Europe, the United States, Japan in the world have complete sets of technology and products, while China has no similar products on the market.

“The Chongqing-made Yongrenxin artificial heart will change this situation.” Zhang Benyan, Chairman of Chongqing Yongrenxin, said that the artificial heart derived from years’ development and design by Japanese R&D institutions. After introducing to Chongqing, the technology was improved. An implantable left ventricular assist system with centrifugal pump structure was adopted, which was composed of in vivo and in vitro components.

Model of Artificial Heart.

Under the promotion of the municipal government, Chongqing Yongrenxin company introduced “Yongrenxin” project from Japan in 2013, and established a JV in Chongqing the following year for cooperative research and development, and then the product entered the special examination and approval procedure of national innovative medical devices. Early in 2018, the clinical trial of Yongrenxin artificial heart started, and 15 clinical implantation operations were successfully implemented successively. All the patients recovered well after the surgery without complications, which was praised as “the best clinical achievements in the world” by foreign scholars, and thus was approved for registration and market in advance.

Zhang Benyan said that at present, Chongqing Yongrenxin had confirmed cooperation intention with many domestic cardiovascular disease centers and large medical institutions, and would carry out professional medical training in Beijing this October. It is expected that the sales volume of this product will reach tens of millions of yuan next year and exceed RMB 2 billion within five years. At the same time, the company is launching the technology introduction of the second generation of a miniaturized blood pump, which is smaller and lighter, thus further benefiting patients with heart failure.