The first domestic artificial cervical disc has been successfully used in surgery

Introduction: The design and application of artificial cervical discs began in the 1960s, and the development began in the 1980s. To date, only a handful of prostheses have been approved for clinical use. China has carried out artificial cervical disc replacement surgery since the end of 2003. It has been imported products for many years. Recently, the first domestic artificial cervical disc has been successfully used in surgery. Experts believe that this will help break the monopoly of Europe and the United States in the field of cervical surgery. .

Cervical spondylosis is a common disease caused by degenerative lesions of the cervical intervertebral disc and its secondary intervertebral joint changes, stimulating or oppressing adjacent tissues, causing corresponding symptoms and signs. It is reported that at present, the number of patients with cervical spondylosis in China has reached nearly 200 million, and the age of patients has shown a trend of younger age.

In the early stage of treatment of cervical spondylosis, the posterior decompression method was used, but the decompression effect was not satisfactory. In 1955, Robinson and Smith proposed to be removed from the front of the cervical herniated disc, and be interbody fusion, after anterior cervical decompression, discectomy, interbody fusion has become the most widely used surgical method, which has a compression symptoms disarmament of the spinal cord and nerve roots good effect, but after cervical spine surgery lost the corresponding motion segment, resulting in reduced range of motion of the cervical spine, pressure on adjacent segments will increase by this also caused some new symptoms. Later, the emergence of cervical artificial disc replacement, providing a new option for the treatment of cervical disease. Anterior reduced pressure after cervical discectomy, implanted in the intervertebral space functional artificial cervical disc prosthesis, which can simulate the function of the normal cervical disc and buffering activity oscillation motion segment retained, thereby maintaining the cervical the activity and stability, reduce the secondary degeneration of adjacent segments. According to the intranet-medical device registration approval database, the products in the artificial cervical intervertebral disc market in China are all imported, and the origin is Switzerland, Germany and the United States.
Table 1: Artificial cervical disc approval


The Bryan intervertebral disc was designed by American Vincent Bryan in the late 1990s and is a metal-polymer friction interface prosthesis. It is composed of upper and lower end plates and an artificial nucleus in the middle. The prosthesis is fixed to the upper and lower vertebral bodies from the front by screws. At the same time, the titanium microporous spray layer facilitates the biological growth of the bone growth, and the pseudo-inferior layer is semi-transparent. Membrane-like material composition, connecting the upper and lower endplates, enclosing the nucleus pulposus, and infusing sterile physiological saline to reduce friction. The Bryan prosthesis is currently the most widely used artificial cervical disc.

The Prestige cervical disc is a metal-metal friction interface prosthesis. It consists of two stainless steel sections that are joined to each other by a projection and a grooved portion. After the original damaged disc is removed during surgery, it is fixed to the adjacent vertebra by a bone screw. This artificial intervertebral disc mimics the function of normal intervertebral discs, and patients can flexibly move their necks after surgery. The Prestige cervical disc was approved for marketing in 2007 and is the first artificial cervical disc approved by the FDA for the treatment of cervical spondylosis.

Subsequently, after continuous efforts by scientists, artificial cervical discs have been improved and developed. PrestigeLP, a modified version of Prestige, and cervical intervertebral disc prostheses such as Discover, PCM, Prodisc-C and Mobi-C have been introduced. The Chinese market. In terms of price, the data shows that each is about RMB 4 to 70,000.
Table 2: The winning price of some artificial cervical discs


In the middle and late 20th century, in order to transform, Medtronic carried out internal adjustments on the one hand and began a cross-border M&A journey on the other. In 1998, he successfully acquired SofamorDanek, a top company that provided treatment solutions for neurological and spinal system disorders. The Bryan intervertebral disc and Prestige cervical disc used for artificial cervical disc replacement surgery were the main products of SofamorDanek, which was brought to Medtronic. Good performance. However, in the past five years, in the context of slowing global business and geographic demand growth, increasing price pressures, and low utilization of medical devices in the United States and Europe, although the annual sales of its spine business has exceeded $3 billion, the growth rate has been It started to slow down.
Figure 1: Sales of the Medtronic spine business in the last five years (unit: billion US dollars)


Although the quality of the imported artificial cervical intervertebral disc is good, according to the design of the cervical vertebra structure of European and American races, there is often a mismatch in Chinese patients, which seriously affects the effect of replacement surgery. This problem has recently been broken. Professor Liu Hao, deputy director of the Department of Orthopaedics, West China Hospital of Sichuan University, and Chuangsheng Group have jointly developed an artificial cervical disc that is more suitable for Chinese people. It uses titanium alloy, high molecular polyethylene and other materials. It has been verified at the German Testing Center in the early stage and its wear resistance is higher than most imported products. In terms of price, the domestic artificial cervical intervertebral disc also has obvious advantages, and the unit price may have a drop of more than 50%.

In recent years, the state has attached great importance to the innovation of medical devices. In February this year, the "Special Approval Process for Innovative Medical Devices (Trial)" was also introduced. At present, the clinical trial project of this domestic artificial cervical intervertebral disc has been approved by the relevant state departments and entered the formal implementation stage. It is expected to be widely applied after two years. With the support of the policy, it will promote the process of the domestic artificial cervical intervertebral disc, whether it can compete in the market in the future, or to compete with imported products, it is worth looking forward to.

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