How will this "immature" track be rewritten after the 8-province joint mining?

On October 18, the Shaanxi Provincial Medical Insurance Bureau issued the "Implementation Plan for the Centralized Procurement of Pacemakers in the Provinces (Regions, Corps) of the Inter-provincial Alliance", and decided to use it in 8 provinces (districts, corps) including Shaanxi, Gansu, Ningxia, and Xinjiang.
, To carry out centralized procurement of dual-chamber pacemakers that have obtained the medical device registration certificate of the People’s Republic of China
.

In the aforementioned eight provinces (regions, and corps), all public medical institutions (including military hospitals) that carry out cardiac pacing operations participated, and medical insurance designated social medical institutions participated voluntarily
.

The agreed procurement volume is calculated by accumulating 80% of the total procurement requirements reported by the Union provinces (regions, corps)
.

This purchase will also explore the establishment of a province-wide coordinated medical insurance payment policy to determine the selected varieties
.

On the basis of the total budget, the medical insurance fund shall be prepaid to the medical institution in advance at not less than 30% of the total purchase amount of the selected varieties

"Infant" racetracks face collections, but this is nothing new
.

There is a precedent for bargaining

There is a precedent for bargaining

Prior to this (September 8), the Beijing-Tianjin-Hebei Pharmaceutical Joint Procurement Platform issued a notice to form a "3+N" alliance with the voluntarily joined regions such as Heiji, Liao, Meng, Jin, Lu, Sichuan, Guizhou, and Tibet to lead the purchase of coronary drug balls.
Capsules and pacemakers medical consumables
.

In addition to the alliance, there are also provinces that target pacemakers
.

According to incomplete statistics, since 2020, six provinces including Jiangsu, Anhui, Shandong, Fujian, Qinghai, and Yunnan have completed the centralized procurement of pacemakers
.

Zhejiang Province also issued the "Second Batch of Procurement Documents for the Concentrated Supply of Medical Consumables in Public Medical Institutions in Zhejiang Province (Draft for Comment)" on September 23, and the dual-chamber pacemaker was included in the list

The effect of squeezing out part of the price moisture by centralized mining is also very obvious
.

In June of this year, in the fifth round of procurement negotiations for the medical consumables alliance of public medical institutions in Jiangsu Province, pacemakers dropped by an average of 60%, and the highest drop was 69%, from the original price of 50,000 to 60,000 yuan to 20,000 yuan.
Around yuan
.

In the centralized procurement of other provinces, the drop of dual-chamber pacemakers ranged from 13% to 69%

Public information shows that in Shandong Province’s first centralized procurement of high-value medical consumables in December last year, the prices of 5 products of 5 cardiac pacemakers (dual-chamber) companies were reduced by an average of 51.
86%.
The price of 13 products with remote monitoring function and MRI-compatible products was negotiated with the enterprise.
The average price of 13 products was reduced by 16.
86%, and the largest drop was 31.
78%
.

Some companies even voluntarily cut prices.
A pacemaker from Abbott dropped from 65,400 yuan to 45,000 yuan, a drop of 31%; a pacemaker from Medtronic also dropped from 80,873 yuan to 69,000 yuan, a drop of 15%
.

The domestic demand for cardiac pacemakers is still increasing.
According to the data released by the National Interventional Cardiology Forum in 2019, the number of pacemaker implants increased from 39,000 in 2010 to 83,000 in 2018.
Compound growth of 9.
95%; but 95.
7% of the market is occupied by foreign businessmen, which has also formed a situation where prices remain high
.

According to reports, customs statistics in June 2021 show that the average import price of each pacemaker is about RMB 12,336
.

However, the actual price paid by the patient is more than three times the import price, and there is a lot of water in the middle

It seems inevitable to "encircle and hunt" foreign companies in centralized procurement, but the domestic industry has been developing slowly for a long time, and long-term follow-up maintenance is required after the implantation of cardiac pacemakers.
After centralized procurement, will the stability and safety performance of the products be guaranteed?

New products are launched iteratively, but the "old drawbacks" are difficult to overcome

New products are launched iteratively, but the "old drawbacks" are difficult to overcome

As the pacing point that controls the contraction of the atria and ventricles, if the sinus node cannot issue correct instructions, or the cardiac conduction system cannot transmit its electrical signals (conduction block), it will lead to bradycardia
.

Pacemakers are regarded as one of the most effective clinical methods that can cure bradycardia.
They are artificially implanted to stimulate the heart with pulsed currents of a specific frequency instead of the pace point to drive the heart
.

In 1952, Swedish doctor Senning and engineer Elmqvist developed the first pacemaker that could be implanted in the human body
.

In 1958, Senning completed the first human implantation of a cardiac pacemaker

Since then, cardiac pacemaker implantation has undergone three stages: open-chest implantation, transvenous lead implantation without thoracotomy, and implantation of a wireless cardiac pacemaker with a minimally invasive catheter
.

At present, intravenous lead implantation still occupies the mainstream at home and abroad
.

It is to make an incision under the clavicle, and the lead of the pacemaker is passed into the subclavian vein and spirals toward the heart until the right atrium; when the lead is placed correctly and the test is completed, it can be connected to the pacemaker, and then the pacemaker The pacemaker is implanted in a pocket made under the clavicle, and the incision is sutured
.

However, this method can also easily lead to a variety of potential complications, such as wire dislocation, wire breakage, venous thrombosis and obstruction of the superior vena cava branch, severe tricuspid regurgitation, etc.
; in addition, if the wire or capsular bag infection occurs, it is necessary If the entire pacing system is removed, the patient's case fatality rate will also be significantly increased
.

According to the Shell Society, there are only three domestic companies that can produce intravenous implant lead pacemakers, Lepu Medical, Chuangling Cardiac Rhythm Medical, and LifeTech.
However, the main market is still foreign manufacturers such as Biotory and Poco.

.

In July of this year, Boston Scientific voluntarily recalled its implantable cardiac pacemaker, implantable cardiac pacemaker and other two products
.

The domestic sales volume of the involved products was 6,463 .

Poco explained that it identified the release of a small amount of hydrogen in these products, which may lead to low-voltage capacitors and electrical damage, thereby accelerating battery loss, causing no stimulation pulses, and ultimately causing bradycardia
.

Based on the above factors, "wireless pacemakers" appear as more preferred
.

Currently, there are only 3 well-designed leadless pacemakers in the world, including Abbott’s NanoStim leadless pacemaker (renamed Aveir), Medtronic’s Micra VR and Micra AV leadless pacemakers
.

Among them, Micra VR received FDA approval in April 2016 and NMPA approval in June last year
.

Aveir has not yet been officially used in clinical practice due to two major recalls

It is understood that the Micra leadless pacemaker has a volume of only 0.
75 cm3 and a weight of about 1.
75g, but it has a strong battery life, with an expected life span of more than 12 years, and is compatible with 1.
5T/3.
0T MRI scans
.

During the operation, the doctor puts Micra into the vein of the patient’s thigh, and then manipulates the catheter to push it to the heart.
Compared with the traditional 1-2 hours of operation time, the catheter implantation is accurate and the entire operation takes no more than 40 minutes.
Minutes
.

The innovative leadless and capsular bag design also avoids the traces of the subcutaneous capsular bag and surgical trauma, electrode failure and infection complications caused by the implantation of traditional cardiac pacemakers

According to reports, in August this year, Medtronic announced the largest authenticity clinical study since Micra went on the market
.
Clinical data shows that compared with the traditional transvenous (TV-VVI) pacemaker, Micra reduces 38% of intervention after 2 years, and reduces chronic complications by 31%
.

However, the limited battery life and the risk of secondary operations caused by surgical replacement of the battery are still the main clinical problems of wireless cardiac pacemakers
.

If the original device terminates the service, a new device needs to be implanted again
.
According to a study in the Chinese Journal of Arrhythmia, although both Micra and Aveir have recyclable components at their ends, over time, the device will be wrapped in fibrous tissue in the right ventricle, and the speed at which the patient’s tissue will wrap Different, so the time available for retrieval and the success rate are also different
.

According to relevant reports, the current longest time for removal is 4 years after implantation
.
The aforementioned study stated that although each leadless pacemaker only occupies less than 1% of the right ventricular volume, and theoretically at least 3 devices can be implanted if necessary, too many devices in the right ventricular cavity affect the contraction and relaxation of the heart The functional impact is still unknown
.

At the same time, while the leadless pacemaker is well fixed in the atrium, it is also the key to reduce the incidence of perforation complications
.

Under various demands, the R&D end and the manufacturer are working together
.

In June of this year, Nature Portfoli reported that in a paper published by Nature Biotechnology, it described a temporary, implantable pacemaker that does not require leads or batteries to operate, and can be used after a period of time.
It is completely absorbed by the body
.
The device has been tested in a series of animal models
.

On October 18th, according to Med TF news, French Cairdac developed ALPS, the first wireless pacemaker implanted for life without worrying about battery drain
.

The device has a volume of less than 1 cubic centimeter, a large-capacity MEMS piezoelectric energy collector, and a pacemaker function.
So far, Cairdac has applied for 41 invention patents to break through technical barriers and protect product intellectual property rights
.

Although the new and old products are still in the growth stage in technology and clinical, but the centralized procurement and bargaining is undoubtedly a good thing for the medical insurance bureau and patients.
In the future, how the domestic industry will be rewritten will continue to be concerned
.

Note: The original text has been deleted

Reference materials:

Reference materials:

"Review | Leadless pacemaker, the future can be expected", Chinese Journal of Arrhythmia

"Review | Leadless pacemaker, the future can be expected", Chinese Journal of Arrhythmia

"Official Announcement | 8 Provincial Alliance, this kind of consumables may meet the lowest price in history", Cyber ​​Blue Equipment

"Official Announcement | 8 Provincial Alliance, this kind of consumables may meet the lowest price in history", Cyber ​​Blue Equipment

"Seven provinces joint procurement of cardiac pacemakers, the 5 billion market bargaining tide is coming", Health and Knowledge Bureau

"Seven provinces joint procurement of cardiac pacemakers, the 5 billion market bargaining tide is coming", Health and Knowledge Bureau