It is understood that artificial heart has become one of the standardized treatment methods for heart failure recommended by international guidelines. It uses a mechanical pump to deliver blood to the human circulatory system to assist or replace the pumping function of the natural heart. Most patients with heart failure show left ventricular failure. Many patients can effectively spend the waiting period of heart transplantation or live with artificial heart for a long time only by assisting the left ventricle. Some patients can completely recover their own heart function after a period of artificial heart assistance, so that the artificial heart can be taken out.
The international research and development of artificial heart technology began in the 1950s, and experienced the transformation from pulsatile blood pump listed in the 1990s to rotary blood pump listed since this century. The rotary blood pump is marked by the support mode of the rotor, which has experienced the development process from mechanical contact bearing, hydrodynamic bearing to all-magnetic bearing.
The full magnetic suspension blood pump is to arrange a series of magnets and electrified coils in the rotor and pump shell, and make the rotor stably suspend through the magnetic force between them. This support method not only uses blood as lubricant, but also can achieve a much larger suspension gap than hydrodynamic bearings, greatly reducing the shear stress level borne by blood. However, the full magnetic suspension blood pump involves complex multi-science and technology, and its design optimization is very difficult, especially in miniaturization. It is reported that Tongxin Medical has long insisted on challenging the subminiature full magnetic suspension artificial heart, and entered the clinical application with independent basic patent technology, and its product CH-VAD has completely independent intellectual property rights.
It is understood that in 20 16, "CH-VAD" products entered the "green channel" for the special approval of national innovative medical devices, and the registration of FDA in the United States was also promoted simultaneously. "CH-VAD" was approved for clinical trial by the State Administration of Medical Products at the end of 20 18. From 2065438 to March 2009, the first subject was successfully recruited. Four clinical cases have been completed in Beijing Fuwai Hospital and Huazhong Fuwai Hospital, and all four patients have been discharged and are in good condition.
It is reported that since the merger with Bai Sheng International last year, Lan Fan Medical has established a development strategy of deepening the field of cardiovascular and cerebrovascular diseases. Lan Fan Medical has been focusing on high-value consumables and low-value consumables. This investment in Tongxin Medical will further expand the development track of its cutting-edge technology in the heart field, enrich the product line and lay out the heart failure market with great potential in advance.