Edward Life Sciences, the "originator" in the field of heart valves, made its debut at the 3rd CIIE this year and showcased its first domestically approved imported transcatheter aortic valve system SAPIEN 3 and other innovative technology products.
Edwards Life sciences Greater China General Manager Ye Tiancheng said in an exclusive interview with Hay Think during the CIIE: “The CIIE is a major innovation in China and demonstrates China’s openness to global multinational companies. At the same time, the CIIE also serves We provide an important window for us to provide pioneering cutting-edge medical technology to Chinese patients."
Ye Tiancheng said that in the next 3 to 5 years, Edward will bring more innovative products to China and conduct clinical trials, such as the surgical biological valve Inspiris bovine pericardial aortic valve, which can extend the life of the valve and is expected to open the aorta Lifelong disease management for valve replacement; other products include a new generation of transcatheter mitral valve and tricuspid valve repair technology PASCAL transcatheter valve repair system.
"Our goal is to improve Chinese patients' access to innovative medical equipment for structural heart disease and critical patient monitoring," said Ye Tiancheng.
At present, more than 25,000 patients worldwide have participated in SAPIEN 3 clinical trials, and 450,000 patients worldwide have received good treatment through the SAPIEN transcatheter aortic valve system, but this technology is still just getting started in China.
In October 2010, the team of academician Ge Junbo, director of the Department of Cardiology, Zhongshan Hospital, Fudan University, completed the first TAVR operation in China and officially announced that this revolutionary technology has entered China.
In 2017, Qiming Medical's first domestic valve, VenusA-Valve, was approved by NMPA, which drove the blowout development of the domestic valve market, but there is still no TAVR product of any multinational company listed in China.
In June of this year, Edward SAPIEN 3 was approved by the NMPA in China, becoming the first foreign valve product approved by the Chinese regulatory agency.
Academician Ge Junbo, who was the main person in charge of the SAPIEN 3 Chinese clinical trial, recalled: “Edward attached great importance to this trial. They sent a large team, from indications to core laboratory, data analysis, patient evaluation, etc., every step All are very strict. During the clinical valve release process, every step is specifically measured."
Academician Ge Junbo told CBN reporters that in the past, multinational valve manufacturers rarely conducted clinical trials in China, which led to the lack of foreign products in the market. However, with the rapid growth of Chinese market demand, I believe there will be more companies in the future Bring clinical trials to China to do.
According to data cited by Edwards, in China, it is estimated that there are 15 million patients with potential valvular heart disease, and about 100,000 to 150,000 Chinese patients die from valvular heart disease each year. However, due to insufficient knowledge of valvular disease and the relatively immature referral mechanism, only about 1% to 2% of patients with valvular disease in China have received timely surgical intervention.
The heart valve market is a new track with a scale of tens of billions of dollars. In 2019, the global heart valve market is close to US$6 billion, of which the TAVR market exceeds US$4 billion. However, as an emerging technology, the treatment cost of TAVR is still relatively high, with an average treatment cost of more than 200,000 yuan, and it has not been covered by medical insurance, resulting in a low market penetration rate. And compared with the price of similar domestic products, the price of foreign products is expected to be twice as high, which will also limit the share of foreign products in the domestic market. According to data, the ex-factory price of Qiming VenusA-Valve is about 150,000 yuan, and the terminal price is 250,000 yuan; while the microport VitaFlow terminal price is only 180,000 yuan.
The analysis agency predicts that in the future, the first echelon of the domestic valve market will be dominated by two domestically produced and two imported ones, namely, MicroPort, Qiming Medical, Edward and Medtronic.