On February 10, 2021, the porous vertebral fusion device jointly developed by Hunan Huaxiang Medical Technology Co., Ltd., a subsidiary of Hunan Huarui Technology Group Co., Ltd., and the spinal surgery team of the First Affiliated Hospital of South China University was officially approved by the State Drug Administration (NMPA) (registration certificate number: Guoxie Note 20213130105).

Since Smith and Robinson first reported anterior cervical decompression and fusion (ACCF/ACDF) in 1958, it has been widely used in the treatment of cervical spine diseases such as cervical degeneration, trauma and tumor. The birth of titanium mesh and intervertebral fusion device has greatly promoted the development of this technology, but there are still many defects in the clinical application of traditional titanium mesh: titanium mesh needs to be cut, the end face is not well matched with the vertebral endplate, stress concentration and other complications such as poor bone fusion and titanium mesh sinking.

3D printing uses additive manufacturing technology, which can realize complex personalized customization processes that cannot be realized by traditional processes, reduce processing procedures, shorten construction periods, and subvert traditional manufacturing processes. It has been favored by all walks of life, especially in the medical field.

3D printing has also achieved some results in the medical field, and clinical applications are more personalized. Due to the special attributes of the medical industry, personalized products are facing huge challenges in quality control and compliance supervision, which also restricts the development process of 3D printing industrialization to a certain extent, and has become a "stuck neck" project made in China. In response to the national strategic decision to 2025 manufacturing in China, starting from 2016, Hunan Huaxiang Medical Technology Co., Ltd. has used the original intellectual property patent of Professor Wang Wenjun's team of spinal surgery department of the First Affiliated Hospital of South China University to jointly set up a 3D product research and development transformation team to explore the industrial application of 3D printing in the orthopaedic field, and launched the personalized customized large-scale production research and development project of "porous vertebral fusion device". At the same time, the project has been included in the national 13th Five-Year key research and development plan.

The R & D team has lasted for five years and has always adhered to rigorous scientific research attitude and pragmatic scientific research spirit. The product has undergone more than 10 times of structural design iteration optimization and improvement, involving more than 30 mechanical property studies, and has fully carried out biological evaluation on its physical and chemical characterization, cell toxicity and so on. A total of more than 200 large and small animal tests have been carried out, and 108 multi-center clinical tests have been carried out in 5 third-class A hospitals nationwide with Professor Wang Wenjun as PI, until the product is successfully approved for marketing.

Huaxiang Medical and Huashu Hi-Tech have developed medical-grade 3D printing equipment solutions. SLM technology, as one of the main technologies of metal 3D printing, is used in the medical field with fine surface, good connectivity of porous structure, high processing precision, excellent mechanical properties and high processing efficiency.

The multi-hole fusion cage is suitable for vertebral body replacement in cervical degenerative diseases, cervical spine fractures, cervical spine deformities and tuberculosis, and other causes of corpectomy.

Feature 1: anatomical matching

The end face design of the product refers to the big data of Chinese spine anatomy, designs a variety of curved surface angles, expands the contact surface of the end plate, abuts with the anatomy of the spine end plate, completely fits, avoids the subsidence after the prosthesis operation, and improves the initial stability and the fusion rate of the spine bone graft;

Feature two: net structure

Using 3D printing bone trabecula structure, through porous structure, pore size, porosity to make its elastic modulus close to human bone, reduce stress shielding, while taking into account the upper and lower end plate bone growth, improve bone fusion rate and vertebral stability;

Feature three: mass customization

According to the big data analysis of height, angle and size, products of different specifications and models are printed, which truly realizes the personalized design and large-scale production of 3D printing, that is, the so-called "mass customization".

The approval of the multi-hole vertebral fusion device is a milestone breakthrough in the field of 3D printing medical treatment in China, which realizes the localization of SLM technology medical application, excellent product performance, simple surgical operation, small intraoperative damage, low cost and so on. At the same time, the concept of "mass customization" will also have a profound impact on the continuous development of other built-in 3D printing products in the medical field.

With the approval of the first product on the market, it marks an important step for the group company to take 3D printing medical industrialization. The company will strengthen its confidence, pioneer and innovate, forge ahead, and explore on the road of new materials, new technologies, and new product research and development. Advance, serve the society with more high-quality products, build the group into a leading domestic, world-class high-tech enterprise, and contribute national strength to the development of medical and health.

Sinovel Technology Group

Hunan Huarui Technology Group Co., Ltd. is committed to the application research and development of new biological materials, medical devices, 3D printing medical and other fields, providing standardized and customized medical devices for precision medicine. It is a high-tech company integrating R & D, production and service. enterprise. Group Holding Company: Hunan Huaxiang Medical Technology Co., Ltd.

The Group's products cover cardiovascular intervention, oral and maxillofacial tissue repair and reconstruction, orthopedic trauma repair, joint replacement, spinal fixation and fusion and other fields.

The company has accumulated rich experience in medical applications in the fields of 3D printing medical treatment, biodegradable zinc alloy, porous tantalum metal and so on. It has the National Development and Reform Commission's National Engineering Laboratory for Additive Manufacturing of Complex Polymer Structures-3D Printing Medical Application Demonstration Base, Hunan Engineering Research Center for Metal and Ceramic Medical Implants, Hunan Engineering Research Center for Additive Manufacturing, etc.

Multi-line text content element

HTML language content can be parsed after rich text content is bound to data