The first International Cardiovascular Technology and Industry Innovation Summit opened in Shanghai yesterday. The chairman of the conference, Academician Ge Junbo of the Chinese Academy of Sciences, said in an interview that the fully degradable polylactic acid stent (Xinsorb) independently developed by China has completed large-scale clinical trials and entered the special approval procedure for innovative medical devices, which has taken the key to pre-market approval. step.
Bioresorbable stents are a hot topic in global research in recent years and are considered to be the fourth revolution in the history of coronary intervention. It is reported that on September 5, 2013, Academician Ge Junbo led the team of cardiology of Zhongshan Hospital to complete the first implanted X-ray implant with fully degradable polylactic acid stent. Up to now, a total of 1230 subjects have been enrolled. 38 clinical centers across the country participated in the clinical trial.
At the same time, the relevant leaders of the National Food and Drug Administration's Medical Device Evaluation Center also said that China's medical device approval method is advancing reform, and innovative medical device approval with significant clinical application value is expected to receive priority registration and priority technology. Supporting policies such as review and priority administrative review.
According to reports, the pace of innovation in cardiovascular device products in China has been accelerating. For example, stents such as fully degradable stents and magnesium alloy materials have entered the clinical trial stage. Moreover, innovation is not only a high imitation innovation, but a development towards original innovation. The speed at which innovation is transformed into productivity is also rising, from conceptual innovation to the stage of turning from substance to productivity.
Academician Ge said that the review of cardiovascular innovative devices has been accelerated. Up to now, China has approved a total of 55 products to enter the application for special approval for innovative medical devices. Among them, 19 cardiovascular products, accounting for 35%, a high proportion, in a "leading" situation. In the first five months of this year alone, there were six innovative cardiovascular implant products in China that entered the special examination and approval application review process of the State Food and Drug Administration. In terms of market size, the sales volume of cardiovascular interventional devices is second only to the in vitro diagnostic market, ranking second, and the compound growth rate has increased rapidly in recent years. Under the background of the aging trend and the high incidence of chronic diseases such as cardiovascular and cerebrovascular diseases, the market demand for cardiovascular interventional devices is huge, and the industry has good development prospects.
Specific to the level of listed companies, Lepu Medical, Xinlitai and other listed companies have invested heavily in cardiovascular stents to carry out in-depth research and development. According to market analysis, Lepu Medical's fully degradable stent is expected to be launched this year and next, and is expected to become the first domestic biodegradable stent. Xinlitai's degradable cardiovascular stents are undergoing relevant clinical trials and data collation. As the leading company in the industry, the core competitiveness of the company's vascular product line (drugs + devices) will be significantly enhanced.
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