Magnesium and its alloys are known as "revolutionary medical metal materials", which can be degraded in the human environment and absorbed by the human body, which avoids the problem of the second surgical removal of implanted devices such as clinical titanium alloys and stainless steel. It has become a research hotspot in the field of metal biomaterials at home and abroad. A few days ago, the degradable pure magnesium bone nail product jointly developed by the Institute of Metal Research of the Chinese Academy of Sciences and DGYA Amorphous Metal Alloy Technology Co., Ltd. obtained clinical approval from the State Food and Drug Administration, becoming China's first degradable magnesium-based metal to obtain clinical approval Ⅲ (Implantable) medical device products, marking a breakthrough in the clinical transformation of our products in this field.
It is reported that in addition to the degradable characteristics of degradable magnesium-based metals, the magnesium ions and slightly alkaline environment generated by magnesium degradation can also promote the formation of new bone and promote bone tissue healing. At the same time, magnesium-based metals have good comprehensive mechanical properties of metallic materials, so they have obvious advantages in orthopedic applications. As early as 2004, Yang Ke, a researcher at the Institute of Metal Research of the Chinese Academy of Sciences, led the team to carry out research and development of degradable magnesium-based metals and related devices. In the development of degradable bone nail products, they use high-purity magnesium (purity ≥99.99%) as the raw material. Compared with the modified WE43 and MgCaZn alloys used internationally, they avoid the problem of accelerated degradation of galvanic corrosion caused by the second phase in the alloy. As well as potential problems in the biological aspects of the second phase, it has higher biological safety.
In addition to degradable pure magnesium bone nails, Yang Ke's team has also developed a variety of degradable magnesium-based metals based on the performance characteristics of magnesium-based metals, including fracture fixation devices, cardiovascular stents, interface nails, gastrointestinal staples, and bone filling materials. Device products, and cooperate with enterprises for clinical transformation of products.