Pinchi Medical has a special approval for domestically produced devices. Medtronic is crying!

2023-09-12 03:08:29

Pin Chi Medical has a special approval for domestic equipment. Medtronic is crying!

The CFDA Medical Device Technology Review Center issued the "Innovation Medical Device Special Approval Application Review Results (No. 6 of 2016)", and agreed to enter a special approval process for a product of Beijing Pinchi Medical Equipment Co., Ltd. (referred to as Pin Chi Medical).

Product Name: Radial nerve stimulation system

Applicant: Beijing Pinchi Medical Equipment Co., Ltd.

Publicity time: June 17, 2016 to June 30, 2016

Just on the 23rd of last month, the CFDA issued an announcement stating that the “implanted vagus nerve stimulation pulse generator kit” and the “implanted vagus nerve stimulation electrode lead kit” produced by Pin Chi Medical were approved on May 16. Two products are on the market.

These two approved products are the first domestically produced products of vagus nerve stimulation for epilepsy, breaking the monopoly of US and Australian companies in China. To this end, it was approved for listing announcement, CFDA is specifically issued separately, and is also recommended in important positions on the official website.

It is these two vagus nerve stimulation products that also set a rapid record of CFDA approval for innovative medical devices. From the announcement of the end of December last year, it was announced that it would agree to enter the special approval process. By approving the product launch in May this year, CFDA only spent more than five months!

Back in the early years, the first product launched by Pinchi Medical, which is the brain pacemaker that got the registration certificate in May 2013, is also the first domestically produced product independently researched and researched by the Ministry of Science and Technology. The eleventh five-year premiere in the field of people's livelihood.

At that time, CFDA has not yet introduced an innovative review method for special medical devices, otherwise it is afraid that his family will be able to enter the fast-passing channel from the first product and get super preferential treatment.

As a well-received “national product” manufacturer, who is the direct competitor of Pin Chi Medical?

Medtronic.

The first self-developed Chinese-made brain pacemaker was originally dominated by Medtronic, but the brain pacemaker of Pinchi Medical was chased as a latecomer, and now it can't keep up with the total amount of surgery, but the growth rate is more than Medtronic. According to relevant data, the amount of Medtronic brain pacemaker surgery has increased by more than 1,000 cases a year, and Pinchi Medical's brain pacemaker can increase 1000 cases in half a year.

The brain pacemaker plus the approved vagus nerve stimulation products, together with the latest sacral nerve stimulation system entering the CFDA rapid approval channel, Pinchi Medical relies on national laboratories, in the development and production of neuromodulation products, the more The faster you go, the more products you roll out.

For Medtronic, which has a monopoly position in the field of implantable neuromodulation products, it is not good news for Pinchi Medical to push new products.

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