China's first transcatheter prosthetic valve to open the era of interventional heart valve treatment

China's first transcatheter prosthetic valve to open the era of interventional heart valve treatment

June 05, 2017 Source: Xinhuanet

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Recently, Hangzhou Qiming Medical announced that its first transcatheter prosthetic valve product, Venus A-valve, was officially approved for marketing. This means that for high-risk patients with severe aortic stenosis, aortic valve replacement can be done with only a puncture of the blood vessels, avoiding the risks of traditional thoracotomy and extracorporeal circulation. As a research and clinical cooperation center of Venus A-valve, Academician Gao Runlin of the National Cardiovascular Center of Fuwai Hospital of Chinese Academy of Medical Sciences said that Venus A-valve is specially developed for the characteristics of Chinese patients with aortic valve stenosis, and is more similar in the world. Suitable for Chinese patients, this is the first Chinese-made innovative cardiovascular disease device approved before the import of similar products. It also means the opening of the era of heart valve treatment.

Avoiding risks such as thoracotomy and cardiopulmonary bypass for elderly patients at high risk

According to the "China Cardiovascular Disease Report 2015" data, the prevalence of cardiovascular disease is on the rise, and it is estimated that there are 290 million cardiovascular patients in the country. It is estimated that by 2030, the number of deaths due to cardiovascular disease in China will reach 7.7 million. There are at least 1 million elderly patients with aortic valve in China, and about 200,000 new patients are added each year, and less than 1% of patients are currently able to undergo aortic valve replacement surgery.

Hangzhou Qiming Medical, which is invested and hatched by Denno, is committed to the development of the world's leading interventional artificial heart valve products. In April of this year, the Venus A-valve percutaneous interventional artificial heart valve system produced by Qiming Medical was approved by the State Food and Drug Administration (CFDA) and officially listed in China. As the transcatheter aortic valve product with independent intellectual property rights of Qiming Medical, the core technology is that it does not need to open the chest or punch the heart. It only needs to puncture the blood vessel to complete the aortic valve replacement, and does not operate the heart. The heart is not damaged, and the postoperative recovery is fast. It avoids the risk of thoracotomy and cardiopulmonary bypass for high-risk elderly patients. This is a significant benefit for high-risk patients over 75 years old with severe aortic stenosis.

Gao Guozhen, deputy director of the Equipment Registration Department of the State Food and Drug Administration, said at the listing conference held here that the State Food and Drug Administration is constantly improving the medical device regulatory system and fully promoting the reform of medical machinery approval. As a representative of China's high-end innovative medical devices, the approval of Venus A for the market, which brings health improvement to patients with aortic stenosis who cannot undergo surgery, will also bring huge economic benefits. Next, the Food and Drug Administration will continue to strengthen supervision and protect patient safety. At the same time, continue to strengthen innovation work, and constantly improve the working mechanism. The priority approval procedures have been established for products listed in the national key R&D plans for major science and technology projects and medical devices. In the future, we will further increase support for independent innovation products in China's medical device industry. Play a greater role in promoting healthy China's construction.

Break through the domestic "customs" after the first foreign countries, establish a global clinical medical cooperation system

In recent years, with the advancement of medicine and people's concern for health, the domestic medical device market has developed rapidly, but domestic medical device companies still face the dilemma of late start of industrial development and weak market competitiveness.

"At present, most medical technology innovations come from countries such as Europe and the United States. The high prices of imported high-end medical devices in China are very difficult for most people in China. At the same time, foreign advanced medical technology usually has to delay 2-3 years before entering China. As a result, the Chinese people cannot enjoy the health improvement brought by advanced medical technology in the first time.” Zhao Yiwei, the chairman of Deno Technology Co., Ltd., said that with the improvement of China’s scientific and technological strength, many national innovations have reached or even advanced internationally. Level. At the same time, with the maturity of China's capital market, it is possible to introduce more foreign innovative technological achievements into China. In this context, Deno utilizes the rich R&D and operational experience in the medical device industry to focus on disruptive technological innovation in the biomedical field through the Denso model.

Zhao Yiwei revealed that the Deno model is mainly reflected in the establishment of a global clinical medical cooperation system, the adoption of capital and professional operations to incubate two-wheel drive, the adoption of innovative talent introduction and management mechanisms. For example, Deno has established a close “medical worker transformation” cooperation system with well-known medical experts in many fields at home and abroad to jointly promote subversive technology into the international market competition. On the same day, the National Veterinary Materials Engineering Technology Research Center Advanced Vascular Material Engineering Laboratory also held a ceremony, which consisted of the National Biomedical Materials Engineering Technology Research Center, Qiming Valve Research Institute and Hangzhou Deno Technology Co., Ltd. Focus on the research and development of biomaterials in medical devices and transform scientific research results.

“Compared to licensing, it is more important to combine academic research, clinical resources and industry.” Zhao Yiwei said that at present, Deno focuses on cardiovascular diseases, tumors, surgical robots, and chronic disease management. Related diagnostic and therapeutic techniques are making efforts to create two platforms: “One Heart and One Lung”, namely, the cardiovascular disease treatment technology platform and the lung disease precision diagnosis and treatment technology platform. In addition to the Venus A-Valve, there are second and third generation products in the development process, including the preloaded transcatheter aortic valve Venibri, as well as a new conveyor system with recyclable function and brain protection. While focusing on R&D and innovation, Qiming Medical also focuses on the global market. In September 2016, global clinical research on the pulmonary valve has officially begun; pre-loaded with the third-generation main valve with thrombolytic protection, global clinical research is expected to begin at the end of 2017. (Liu Ying)

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