Since 2014, the process of localization of medical devices has accelerated. The author recently learned that a self-developed minimally invasive heart valve implant system is expected to receive clinical approval from the US Food and Drug Administration and the EU CE certification this year, which will inject a dose into the increasingly diversified and internationalized local medical devices. Strong heart.
Small devices are expected to break the monopoly pattern
Aortic stenosis and regurgitation are a serious common senile disease. As the age increases, the patient's survival time is about 5 years. Previous surgical procedures have high trauma, high risk, and high patient suffering. There are more than 1 million cases of aortic stenosis and regurgitation in our country, and most of them are not treated effectively because they cannot tolerate surgery. As the society ages more and more, patients with valvular disease can not only treat elderly patients who cannot undergo surgery, but also solve the social medical burden if they can get early intervention.
Previously, an 81-year-old patient had not only severe aortic regurgitation, but also cerebral apoplexy, severe emphysema, multiple pulmonary bullae, complete left occlusion of the left carotid artery, severe aortic arch and brachial artery calcification. Zeng Yi went to seek medical treatment, but they were rejected by many hospitals because of the high risk of surgery.
The patient then transferred to the Zhongshan Hospital affiliated to Fudan University to receive the "perician minimally invasive aortic valve replacement", using the self-developed domestic valve J. Valve, no thoracotomy, less bleeding, and subsequent angiography and echocardiography confirmed that the new valve is working perfectly. It is understood that the average operation time of the similar surgery performed by Zhongshan Hospital is 80 years old, and the average hospital stay is only 5 days.
Wei Lai, director of minimally invasive cardiovascular surgery at Zhongshan Hospital, said that the minimally invasive aortic valve replacement is the most advanced and minimally invasive heart valve replacement technology in the world. It does not open the chest and the heart stops, greatly reducing the operation. Trauma and risk have great advantages for high-risk patients. Compared with similar foreign products, J. Valve is accurate, easy to operate and easy to master. In addition to the treatment of aortic stenosis, it can also be used to treat aortic regurgitation, which is incomparable to foreign products.
Guo Yingqiang, deputy director of Cardiovascular Surgery, West China Hospital, said in an interview with the author: "When using imported products, it is like two people who are constantly beating to try to complete the capping of the cap. A slight offset may cause paravalvular leakage. Although the imported products are now optimized and the second generation is launched, from the perspective of design dexterity and ease of use, the domestic valve J. Valve is superior. Due to the approval process, the latest foreign products have not entered the Chinese market. If local innovative products can be listed earlier, it will bring about major changes in the domestic medical market."
“The price of domestically produced valves will be better than the import price after the market launchâ€, and the chairman of Suzhou Jiecheng Medical Technology Co., Ltd., which was selected as the “Thousand Talents Plan†of the country, is also J. Valve's inventor Zhang Ji said that Medtronic and Edward's two foreign brands now almost monopolize the market for interventional valves. Once China's products can be approved for overseas listing, it will not only bring more gospel to more patients, but also effectively improve our country. International competitiveness and voice in the field of high-end medical technology.
Domestic medical equipment was at the time
In January of this year, Shanghai Mini-Chuang Medical Devices (Group) Co., Ltd. independently developed the third-generation drug stent Firehawk coronary rapamycin drug-targeted eluting stent system obtained EU CE certification. "Firehawk is the Group's first CE-certified medical device combination and an important step in the internationalization of the minimally invasive cardiovascular business. In the future, it will benefit more patients in Europe and the CE certification area." Lin Yingqing, vice president of MicroPort International Business, said .
Looking at the development of the domestic medical device industry in recent years, diversification and internationalization have gradually become a major trend. Especially in 2013, Fosun Pharma's $240 million acquisition of a medical beauty equipment company in Israel; in June of that year, Mindray Medical acquired a US ultrasound system company for $105 million. The domestic medical device company that used to be the target of multinational companies’ acquisitions began a counterattack.
According to data from the China Investment Group, in the 66 cases of medical health VC/PE financing in 2014, 23 medical equipment financings accounted for 23%, of which Suzhou Xinrong Bolt Medical Devices Co., Ltd. received Blackstone financing of US$150 million.
The industry believes that compared with biopharmaceuticals, the investment advantage of medical devices is that they can achieve a considerable rate of return in the short term, and the wave of mergers and acquisitions in the field of medical devices that continue to be hot has also seen the market, and the development space of the high-end device market has gradually opened. Debon Securities analysis said that from the continuous exploration of a number of excellent domestic equipment manufacturers in the high-end medical equipment, the future domestic high-end medical equipment is completely possible to achieve import substitution, this process will not have "ceiling".
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