Pacemakers are imported at higher prices, and domestic production needs to be expanded to improve quality.

"The number of implanted pacemakers in China accounts for only 10% of the total number of implanted patients. This proportion is far lower than in developed countries such as Europe and the United States. Ventricular fibrillation is a dangerous disease that can lead to sudden death. Only the heart is installed. Pacemakers can prevent the sudden death of the patients to the maximum extent, and the number of people who implant pacemakers in China only accounts for 1/500 of the world.” January 9, First Department of Cardiology, First People's Hospital of Guangzhou, 2012 On the day of the event, Luo Yiru, director of the Department of Cardiology, was introduced.

"I can't afford" to hinder

In the past 20 years, due to the continuous improvement of the living standards of our country and the dramatic changes in the dietary structure, the intake of high-fat, high-protein and high-calorie foods has become one of the major factors affecting the change of national disease. Long-term intake of high-fat foods is a major factor in the induction of heart disease.

According to the sample survey results of relevant departments in rural and urban areas of several populous provinces in China, it is estimated that there are approximately 540,000 newly-increased atrial fibrillation patients or heart failure patients every year in China. At least one half of them need to install pacemakers. However, in fact, in the past few years, only an average of 20,000 to 30,000 cardiac patients each year installed cardiac pacemakers, which is 1/9 of the total number of people who need to install pacemakers. In recent years, sales of cardiac pacemakers have doubled from previous years as national incomes have increased and economic conditions have improved. According to the statistics of China's pharmaceutical business sector, in 2009, a total of 48,992 cardiac pacemaker products were sold in China, of which only 5,000 were domestic-made pacemakers, and imported products still dominated the market.

The installation rate of pacemakers in our country is so low, according to Luo Yi, on the one hand, due to insufficient coverage of economic factors and medical insurance. Since most cardiac pacemakers are currently imported products, the price is relatively high for most patients. The more important reason is that patients lack medical basic knowledge and lack of trust between doctors and patients. The majority of heart disease people in China mistakenly believe that if they take drugs like amiodarone can prevent heart attacks, installing a pacemaker is difficult for them to accept, and some heart patients are worried about pacing. The device will be harmful to the body and refuse to install. The Department of Cardiology of the First People's Hospital of Guangzhou City often suffers from instances in which heart patients and their families refuse to install a pacemaker.

Luo Yi pointed out that the main indications for cardiac pacemakers are sick sinus syndrome and atrioventricular block. In most cases, pacemakers are prepared for people who have a slow heart rate and cause discomfort. Cardiac pacemakers should be implanted when the heart is stopped for more than 3 seconds or the heart rate is often less than 40, especially in patients with black eyes and sudden fainting. This is the main and initial treatment of pacemakers. At the same time, some diseases can cause cardiac arrest or fatal malignant ventricular arrhythmias (such as rapid ventricular tachycardia, ventricular fibrillation), can install defibrillator function pacemakers, restore the heart regular beating. In addition, pacemakers are used in certain cardiac therapies (carotid sinus hypersensitivity syndrome, vasovagal syncope, idiopathic Q-T prolongation syndrome, prevention of rapid atrial arrhythmias, etc.) Indispensable and even the only treatment.

According to industry sources, in developed countries in Europe and America, the current average price of each pacemaker is between 2,000 and 2,500 US dollars (including implant surgery costs), and many European welfare countries such as Sweden, the United Kingdom, Switzerland, Denmark In Germany, Finland, the Netherlands, Germany, and other implanted pacemakers can reimburse all (or part of) costs, so in developed countries, basically all heart patients who should have pacemakers have pacemakers installed.

Relevant departments estimate that there are 700,000 types of pacemaker products sold in the international market at present. Although China is the world’s most populous country, and there are so many patients died of cardiac diseases every year, the pacemakers are actually installed. There are only tens of thousands of people in the district. Last year, the actual sales of pacemakers in China were only 1/14 of the total global sales.

At present, Shaanxi Qinming Medical Instrument Co., Ltd., the only manufacturer of cardiac pacemakers in China, has made rough statistics. At present, about 200,000 people in China are wearing cardiac pacemakers. 99% of the 200,000 people are born abroad. The pacemakers are mainly pacemakers developed by the United States and Germany. Even so, 200,000 people only account for 3% to 5% of the population in China who need to wear pacemakers. Most patients who are not wearing are mainly affected. The constraints of economic factors. According to data analysis, the demand for pacemakers in China is still growing at a rate of 15% per year. By 2020, as China's aging population accelerates, the demand for pacemakers will increase.

The chairman of the company, Zhang Yijing, told reporters that for the development of cardiac pacemakers, the domestic market has not yet been fully developed and has great potential. According to the proportion of foreign patients implanted products, China annually The demand for products should be about 600,000, but currently it is only about 20,000. There are three reasons for such a large gap. One is that the concept is backward, many people do not understand the product, and they cannot even correctly understand the purpose and role of the product; second, there is not enough publicity, especially in remote rural areas; The constraints, many people do not have enough family economic support.

According to Luo Yi, with the development of the economy and the government’s emphasis on people's livelihood and health care, medical insurance now supports more and more pacemakers. The proportion of reimbursement has risen from 50% to 60% or even 70%. Some areas with good economic conditions can even reach 80% to 90%. The coverage of medical insurance is gradually expanding, which undoubtedly provides the impetus for the pacemaker market to break out.

Domestic need to break through

Looking back at the history of pacemaker development, from the invention of the world's first implantable pacemaker in 1960, it has been nearly 50 years. On September 27, 2011, Wilson Greatbatch, an inventor of an implantable cardiac pacemaker, died at 92 years old in Buffalo, New York. In this short 50 years, the pacemaker technology has developed rapidly. From the initial resolution of bradycardia to the current anti-arrhythmia (ICD) and corrected heart failure (CRT), the concept of pacemaker has been completely renewed.

Although cardiac pacemakers are indispensable products for patients with bradycardia, due to higher technical barriers to product technology, according to the reporter’s knowledge, the market space for domestic pacemakers is currently about 2 billion yuan, which is completely monopolized by foreign products. With the increase in the proportion of Medicare reimbursement, it is expected that the market demand in 2015 will reach 400,000, and the market space is expected to expand to 12 billion yuan.

According to data from the China Business Intelligence Network, from January to November 2011, the import volume of cardiac pacemakers in China was 60,800, an increase of 2.5% year-on-year; the import amount was US$83.98 million, an increase of 12.9% year-on-year. From this calculation, from January to November 2011, the average import price of cardiac pacemakers in China was 1380.58 US dollars/a.

In other words, while the number of imported cardiac pacemakers in China is steadily increasing, the price growth rate is significantly higher than the number growth rate. This calls for domestic pacemakers to rapidly expand production scale and improve product quality.

"A lot of patients may be worried about installing pacemakers. In fact, it is safe to install pacemakers. The Department of Cardiology of the First People's Hospital of Guangzhou began to perform pacemaker surgery in 1981. The number of installations per year is more than 50, and the technology is very mature. Luo Yi said.

According to Luo Yi, implanting pacemakers is a very common minor surgery today. In most domestic top-three hospitals, trained doctors can perform in the operating room or cardiac catheterization room, which takes about 1 hour. This process requires very little local anesthesia, which means that the patient will be awake and can be relaxed for surgery.

The pacemaker is mainly composed of two parts, the pulse generator and the electrode lead. The pulse generator periodically emits stimulation pulses at the frequency set by the doctor instead of the sinus node. The electrode lead is sent through the vein into the right ventricle and the other end is connected with the pulse generator, so that the pacemaker always knows whether the ventricle has its own electrical activity (medically known as sensing function). Surgery usually involves cutting a transverse incision in the upper chest below the clavicle and passing the pacemaker's electrode lead through the subclavian vein into the heart. The doctor fixes the front end of the pacemaker electrode to a specific part of the heart chamber through the indication of a television screen (an X-ray monitor). The next step is to connect a compact pulse generator (ie pacemaker) to the electrode lead, place the pacemaker under the skin in the incision, and finally suture the skin and close the incision. At the time of treatment, the doctor will choose the appropriate pacemaker to install according to the patient's specific conditions. The service life of a single heart chamber pacemaker is 8 to 10 years, and the service life of a double heart chamber is 6 to 8 years.

There are many types of pacemakers. At present, there are also many companies selling in the country. The most famous are pacemakers produced by Medtronic, St. Jude, and Hundred. At present, single-chamber pacemakers need about 25,000 yuan to install, dual-chamber pacemakers are about 45,000 yuan, and more advanced features require 60,000 to 70,000 yuan or 100,000 to 200,000 yuan.

It cannot be denied that the price is expensive because of the backwardness of domestic products. Shaanxi Qinming Medical Instrument Co., Ltd. was established in 1986. The joint venture introduced foreign technology to start assembling foreign products. Compared with foreign research and development of related products in 1959, the gap between domestic and international products is still very large. According to the latest foreign news, the latest wireless pacemaker developed abroad is already brewing into the clinical stage.

It is reported that a few years ago, several companies in Shanghai, Beijing, and other large cities used imported components to assemble cardiac pacemakers. However, due to factors such as poor sales, these pacemaker manufacturers have now stopped production. At present, only Shaanxi Qinming Medical Instrument Company is in production, and another Hangzhou Nengxinxin Medical Devices Co., Ltd. product is still in the research and development stage and it is not listed.

On the other hand, the price of domestically produced products should be at least 1/3 lower than that of imported products. According to the reporter’s understanding, electronic technology researchers from universities such as Xi’an Jiaotong University and China’s University of Science and Technology have successfully developed localized ASIC microprocessor integrated circuit products several years ago. They can be corrected by installing them on pacemakers. The effect of abnormal heart rate. It is said that the cost of such a localized ASIC integrated block is only 500 yuan, if all domestically implemented (provided that the need for large-scale production), coupled with the pacemaker's hardware and long-lived batteries and other supporting components, it is estimated that The cost of each domestic pacemaker can be controlled within 2,000 yuan and the selling price can be between 3,000 and 4,000 yuan. This kind of price pacemaker product certainly has the enormous development space in the market.

Although the market prospects are promising, due to the backwardness of technology and the immature sales network, and the public’s understanding of the “imported” high-end medical products, it is still a big challenge for domestic cardiac pacemakers to be able to break through the market. However, with more powerful capital and business entry, this situation may have improved.