Mi thos, January 2021 ® Transcatheter mitral valve replacement system (MI thos) ®”） It was successfully approved by the genetics Office of the Ministry of science and Technology (No. 2021bal0042) and officially entered the stage of clinical research registration. Mi-thos ® Led by the team of Shanghai newpulse medical and national biomedical materials engineering technology research center, and director Wang Chunsheng of Zhongshan Hospital, it is a product that has been successfully developed for many years and has won the support of the national 13th five year plan project and the science and technology innovation action plan of Shanghai Municipal Science and technology Commission. Mi-thos ® It is expected to become the first product of transcatheter mitral valve replacement in China, which will benefit the majority of patients with mitral regurgitation (MR).

Mitral regurgitation (MR) is the most common heart valve disease in the elderly. At present, the mainstream treatment method is to replace the valve by open chest surgery, which is traumatic and has a long recovery period. Most of the patients give up treatment because of the existence of a variety of complications and high risk of old age. Transcatheter mitral valve replacement (tmvr) has greatly reduced the surgical trauma and become another research hotspot after transcatheter aortic valve replacement (TAVR). As the Himalayan peak of valve industry, many medical and engineering teams in Europe and the United States have invested heavily in the research and development of tmvr technology in recent years. However, due to the complexity of mitral valve structure and high technical barriers, the research and development is very difficult. At present, most of them are in the exploratory or early clinical exploration stage.

As a leading enterprise in valve industry, especially in the field of mitral valve, Newcastle Medical Co., Ltd. was founded with the mission of "innovation for life", deeply distributed valve field, accurately identified clinical needs, and focused on research and development plan of national 13th five year plan and action plan of scientific and technological innovation of Shanghai Municipal Science and Technology Commission - production, study, research and research Under the framework of "research and development of new type of mitral valve replacement system and achievement transformation" of medical cooperation project, the combination of deep cultivation and medical engineering has successfully developed Mi thos ® Transcatheter mitral valve replacement system (MI thos) ®”）。 Mi-thos ® The system is to transfer the valve to the mitral valve area and expand it after the small incision of the apex, which replaces the lesions of the mitral membrane. Traditional thoracotomy usually takes four to five hours, while Mi thos ® The system can complete valve implantation in just one hour. Mi-thos ® The system is designed according to the pathological anatomy of Chinese people. The innovative design concept of "rigid and flexible" internal and external double-layer stent is adopted to care for the Chinese "heart". Mi-thos ® The D-shaped structure of the outer frame can effectively fit the physiological structure of the mitral valve, and the sealing membrane is used to prevent the leakage around the valve. The unique three-layer barb anchoring structure can effectively prevent valve displacement and improve the safety of operation.

Mi-thos ® Successfully entering the clinical stage of registration is a major breakthrough in the field of mitral valve replacement in China, and also marks the further improvement of independent innovation and R & D capability of domestic devices. At present, the second generation of new pulse medical mitral valve replacement system has made a breakthrough, and the first exploratory animal experiment has achieved good results. The company's innovation road in the mitral valve field constantly breaks through the bottleneck of domestic device development me too, and realizes the transformation from me better to me beyond.