Following the merger and acquisition of the world's fourth largest cardiac stent manufacturer Parsons Brinckerhoff International only one year later, listed company Lanshan Medical (SZ.002382) once again to encode the cardiac field device market.
On June 18th, Lanshan Medical announced that the company and several executives jointly invested 101.6 million RMB to invest in the artificial heart research and development enterprise Suzhou Concentric Medical Devices Co. The two parties will jointly promote the clinical, registration and market development of CH-VAD, a magnetically levitated artificial heart, in the global market.
36 Krypton learned that Concentric Medical was founded in 2008, mainly focusing on the research and development of artificial heart, and its product is the full magnetic levitation blood pump artificial heart CH-VAD (complete independent intellectual property rights). It has previously received investments from Hiei Asset, Share Investment and others.
It is understood that the "CH-VAD" product has entered the national innovative medical device special approval "green channel" in 2016, and the U.S. FDA registration is also being synchronized. In addition, "CH-VAD" obtained the clinical trial license from the State Drug Administration at the end of 2018, and the first case of subject enrollment in March 2019, and has completed four clinical cases in Beijing Fuwai Hospital and Huazhong Fuwai Hospital.
It is reported that during the period of June-October 2017, the team of academician Hu Shengshou of Fu Wai Hospital had CH-VAD used to save three cases of critical patients consecutively, which has been successful in all cases. The first of these patients has been living on the artificial heart for 2 years and maintains a normal and healthy quality of life; the second patient has successfully implemented heart transplantation after 5 months of artificial heart assistance; and the third patient has a fully recovered autologous heart after 5 and a half months of artificial heart assistance and has successfully had the artificial heart removed.
Heart failure is known as the "cancer of heart disease", claiming hundreds of thousands of lives globally each year, and public data show that the number of heart failure patients worldwide has reached 26 million. Once a patient is diagnosed with heart failure, about 50% will die within 5 years, and about 50% will die within 2 years after entering the advanced stage (NYHA class III and IV) of heart failure. Heart transplantation is currently recognized as the only effective treatment for patients with end-stage heart failure.
From Oriental IC
However, the serious lack of heart donors has greatly restricted heart transplantation. Data show that China can only do about 300 heart transplants a year, and even in the United States, where the largest number of heart transplants are performed, there are only more than 2,000 heart transplants per year, and hundreds of thousands of new heart failure patients are added each year, so heart transplants can't become a medical treatment that benefits the public.
The advent of the artificial heart is continuing to improve this problem. It assists or replaces the pumping function of the natural heart by mechanically pumping blood into the body's circulatory system. Most patients with heart failure show failure of the left ventricle. Many patients only need left ventricular assisted therapy to be able to effectively get through the waiting period for heart transplantation or to carry an artificial heart for long term survival, and some of the patients can have their own heart function fully restored after a period of time of artificial heart assisted therapy so that the artificial heart can be removed.
The artificial heart has now become one of the standardized treatments for heart failure recommended by international guidelines, and is mainly used to treat patients with end-stage, refractory heart failure.
The research and development of the artificial heart can be traced back to the 1950s, and has now evolved from the pulsatile blood pumps marketed in the 1990s to the rotary blood pumps marketed in this century. The pulsatile blood pump has been used less and less in the clinic due to the serious damage to the blood components, high incidence of hemolysis and thrombosis, and the large size and poor durability of the device; the rotary blood pump has also experienced the development of mechanical contact bearings, liquid dynamic bearings, and magnetic levitation bearings, with the rotor bearing as the symbol.
Among other things, fully magnetically levitated blood pumps, which do not use blood as a lubricant and can achieve much larger suspension gaps than liquid dynamic bearings, can greatly reduce the level of shear stresses to which blood is subjected, providing even more significant clinical value.
It is reported that HeartMate3 developed by Thoratec, a subsidiary of Abbott, which is the only full magnetic levitation blood pump on the market, has a significant clinical advantage over HeartMate II, the world's largest-selling artificial heart product with mechanical contact bearings, as evidenced by its 2-year clinical trial follow-up results; meanwhile, numerous clinical studies have shown that HeartMate 3 also has a significant advantage over Medtronic's HeartWare's HVAD with liquid dynamic bearings. The HeartMate 3 has also been shown in numerous clinical studies to have significant advantages over Medtronic's HeartWare's HVAD, which utilizes a hydrodynamic bearing.
However, due to the complex multidisciplinary technology involved in fully magnetically levitated blood pumps, the design optimization is very difficult and faces great challenges especially in areas such as miniaturization. To date, only Thoratec and Concentricity Medical have developed technologies in the field of ultra-compact fully magnetically levitated artificial hearts with the maturity to reach clinical applications. (Of the existing implantable artificial heart companies, only Abbott's Thoratec and Medtronic's HeartWare have products licensed by the U.S. FDA for the market, and these two companies account for more than 90% of the global market.)
It is reported that the technological advancement of the artificial heart is mainly in terms of blood compatibility, surgical invasiveness, anti-infection properties of percutaneous cables, and device reliability.
According to the presentation given by the team, the CH-VAD has several advantages over the HeartMate 3: 1) the blood pump is smaller and therefore less surgically invasive; 2) the percutaneous cables contain fewer wires and thinner cables, which creates a lower risk of infection and contributes to the product's reliability; and 3) the magnetically levitated stiffness is higher, the quality of the flow field for the flow of blood is higher (low shear stress, flow flushing adequately), and better blood compatibility obtained from in vitro testing, which may indicate that the CH-VAD may have better blood compatibility.
From Artery.com
Among the existing implantable artificial heart companies, only Abbott's Thoratec and Medtronic's HeartWare have products licensed by the U.S. FDA, and these two companies occupy more than 90% of the global market. Among them, Thoratec owns HeartMate II, an old-generation mechanical contact bearing artificial heart, and HeartMate 3, a new-generation fully magnetically levitated artificial heart; HeartWare only owns HVAD, a liquid dynamic bearing artificial heart.
In terms of the logic of the capital injection, Lufan Medical said that it is now to further expand its cutting-edge technology development track in the cardiac field, enrich the product line, and lay out the market of heart failure, which is full of great potential, earlier.
