Release date: 2016-05-31

On May 23, the CFDA posted a news article "Implanted Vagus Stimulation Pulse Generator Kit and Implantable Vagus Nerve Stimulation Electrode Wire Kit Approved" on its official website home page.

The full text is as follows:

[On May 16, 2016, the State Food and Drug Administration reviewed and approved the "implanted vagus nerve stimulation pulse generator kit" and "implanted vagus nerve stimulation electrode lead kit" produced by Beijing Pinchi Medical Equipment Co., Ltd. Two products.

The "implantable vagus nerve stimulation pulse generator kit" consists of a pulse generator, a test resistor, a torque screwdriver and a control magnet. The "implanted vagus nerve stimulation electrode lead set" consists of an electrode, a tunneling tool (including a puncture tool and a cannula), and a retaining clip.

The combination of the above two products can play a role in controlling seizures in patients with refractory epilepsy whose drugs cannot be effectively controlled. It is the first domestically produced product of vagus nerve stimulation for epilepsy.

The food and drug supervision and administration department will strengthen the supervision of products after listing and protect the safety of patients.

CFDA has to approve so many products every month. Why are these two separate articles and are still hanging in prominent positions?

National project, Tsinghua University is responsible for research and development

Let's take a look at the origin of these two products.

"People's Daily" previously reported that under the support of the "Twelfth Five-Year" National Science and Technology Support Program, China's only national neuromodulation research institute, the National Engineering Laboratory for Neuromodulation Technology, has undertaken the research and development of domestic vagus nerve stimulators. Tsinghua University is responsible for research and development, and Beijing Pinchi Medical Equipment Co., Ltd. is responsible for industrialization.

The leader of the R&D team, the director of the National Engineering Laboratory of Neuromodulation Technology, is a professor at Tsinghua University, Li Luming. In addition to Tsinghua University, Beijing Labus Medical Equipment Co., Ltd. (hereinafter referred to as Pinchi) and Beijing's well-known top three hospitals, Tiantan Hospital, participated in the joint construction.

The so-called national project, "production-study-research-medicine" is closely combined, and the two products approved by CFDA are the same.

Target patients with 2 million people for major diseases

According to the World Health Organization, the prevalence of epilepsy ranges from 5‰ to 11.2‰. There are about 50 million people with epilepsy in the world. There are 9 million epilepsy patients in China, including about 6 million active epilepsy. 25% of patients cannot be controlled by systemic drugs, so they are called refractory epilepsy.

At the same time, there are 400,000 to 600,000 new cases in China every year. Epilepsy has become the second most common disease in neurology after headache.

Based on this calculation, about 2 million people with epilepsy in China need surgery.

Vagusnervestimulation (VNS) is a patient with epilepsy who is specifically used for drug-refractory epilepsy, can not perform craniotomy for various reasons, or undergoes craniotomy, especially in children with refractory epilepsy. .

It is reported that VNS technology as an "electronic drug" for the treatment of epilepsy, the number of patients implanted worldwide has exceeded 130,000, and the annual operation volume is about 20,000. But in China, because the price of imported vagus nerve stimulator is very expensive, the annual amount of surgery is less than 200 people.

In other words, the two vagus nerve stimulation products approved by Pinchi can benefit many patients.

According to Li Luming, a professor at Tsinghua University, their self-developed vagus nerve stimulator is not only small in size, light in weight, but also has precise stimulation parameters and a service life of more than 10 years, which is superior to foreign products.

The products are not inferior, coupled with the obvious advantages of the price, but also the domestic exclusive, the market prospects of these two products is simply a lever.

Production enterprise: "new", but that is quite "high"

Looking at the introduction of Pinchi's official website, you will find that this is a true "high-new" company.

The company was established in December 2008. One year later, the brain pacemaker project of the Institute of Human Machine Environment and Medical Engineering of Tsinghua University landed in Beijing, and the first clinical operation of the domestic brain pacemaker was completed at Beijing Tiantan Hospital. At the beginning of 2011, I got a production license and got GMP certification in July. From the perspective of the founding time, Pinchi is really a new company.

However, the starting point is high. The first product is a domestic brain pacemaker, including a single-sided brain pacemaker, a dual-channel brain pacemaker, a rechargeable computer pacemaker, etc., and all of which are self-developed, the first domestically produced product.

In May 2013, the brain pacemaker received a registration certificate issued by the CFDA, which was the first domestic implantable neuromodulation product. In 2014, several products received the registration certificate issued by CFDA and Beijing Food and Drug Administration. On August 13, the same year, the clinical trial of implantable vagus nerve stimulation for epilepsy was successfully initiated.

Look at the world's first bright eye data:

In May 2015, the world's first 3T MRI-compatible brain pacemaker electrode implantation performed by Tsinghua University and developed by Pinchi Medical was completed at Beijing Tiantan Hospital;

In September 2015, the world's first clinical implant test was carried out by a brain pacemaker with Tactus function developed by Tsinghua University and produced by Pinzhi Medical.

The secondary product is the first implanted vagus nerve stimulator in China.

There are also various countries that value

In March 2012, the Ministry of Science and Technology hailed the domestically produced brain pacemaker produced by the company as the primary achievement in the “11th Five-Year Plan”.

In May 2012, CCTV Science and Education Channel's major scientific and technological achievements tour "Close to Science" column, reported the domestic brain pacemaker independently developed by the company;

In December 2013, Guo Jinlong, member of the Political Bureau of the Central Committee and secretary of the Beijing Municipal Committee, visited the company to evaluate the results of brain pacemakers.

In December 2013, CCTV News reported on the results of Tsinghua brain pacemaker;

In the spring of 2014, Jiao Hong, Director of Food and Drug Safety of CFDA, Deputy Director Yang Zhe of the Social Development Department of the Ministry of Science and Technology, and the Central Inspection Team of the Central Committee visited the company;

In October 2015, he participated in the first National Volkswagen Entrepreneurship Innovation Week, and Premier Li Keqiang and Vice Premier Liu Yandong specially visited the brain pacemaker booth.

Target audience: American companies such as Medtronic?

In the introduction of Pinchi, it clearly stated that the company “specializes in the research, development, production and sales of serial neuromodulation products such as brain pacemakers”, and is also the only national-level research and development base in this field. Room" unit.

The company is to build "the world's second neuro-regulatory industry." Who is the first one? United States.

In the case of implantable neuromodulation products, the world is also dominated by several US companies, including the current global device leader Medtronic.

After reviewing the data on the CFDA website, it will be found that the products that have been approved by the CFDA to date for "implantable nerve stimulation" are all from Medtronic. These include implantable neurostimulators, implantable neurostimulation electrodes, implantable neurostimulation system extension leads, implantable neurostimulation system adapters, and implantable neurostimulation systems.

Named after the "vagus nerve stimulation", there is only one American company's product. The vagus nerve stimulator, vagus nerve stimulator - program controller and software from the American CYBERONICS, INC. company, implanted vagus nerve stimulation electrode lead. This is a small “bovine” company in the United States. Its product range is to control epileptic seizures by stimulating the vagus nerve, exactly the same as the latest approved products of Pinchi.

The vagus nerve stimulator is aimed at patients with epilepsy, while the brain pacemaker is mainly targeted at functional brain diseases represented by Parkinson's disease. For the former, Xiaobian has not yet found the market data of American companies. But Medtronic's brain pacemaker, a data from last November, is that more than 8,000 cases of Medtronic brain pacemaker surgery have been completed in China. The data for November 2014 was more than 6,700, with an increase of more than 1,000 cases in a year.

What about Pinchi? According to its official website data, in June 2015, the total implant volume of Pinchi brain pacemaker exceeded 2,000 cases, and in January 2016 it broke through 3,000 times. In the first half of the year, it increased by 1000 cases, and its growth rate exceeded that of Medtronic.

From the background of the establishment of Pinchi and the support of the state, it is another typical example of domestic consumption against imports and squeezed prices. Before the joint film in the field of equipment against GPS, and Pinchi in the field of high-value consumables against Medtronic, what will the foreign giants do in China?

Source: Beijing Morning News

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