Six among the top ten major weapon companies in the world, ultrasound in the heart cavity is destined to fire?
Author:Arterial network Time:2022.09.19
From a global perspective, well -known multinational companies such as Johnson & Johnson, Abbott, Siemens, Philips, GE Medical, Boston Science have all lay out an internal ultrasound (ICE).
For example, Johnson's Biosense Webster launched Soundstar, an ultrasonic catheter in the three -dimensional cardiac cavity; San Yuda, a subsidiary of Abbott, launched the ViewFlex Xtra Ice catheter; Siemens Medical has launched the Acunav Volume Ice catheter; Philips has launched Verismt Pro 3D Ice catheter; Ultra Ice catheter ...
According to the data, the internal ultrasound (ICE) is an innovative ultrasonic cardiac percentage diagnostic technology that places the ultrasonic probe inside the cardiac cavity and transmits and receives the ultrasound signal Real -time imaging of functions such as function.
As of now, ultrasound in the heart cavity has been applied to various operations such as atrial fibrillation, left -hearted ear blocking, room septal blockage, two -pointed valve deformities, and endometrial myocardial surgery.
Clinical data shows that surgical such as ultrasound in the heart cavity, atrial fibrillation frequency discharge, left -ear sealing surgery improved accuracy and safety, reduced surgery risks, reduced complications, reduced surgical costs, and increased patients at the same time. Comfort and surgical efficiency. In addition, ultrasound in the heart cavity can also effectively reduce the amount of X -ray and reduce radiation to patients and doctors.
For example, clinical studies have shown that using ACUNAV Volume ICE catheter to carry out left -hearted ear blocking can shorten about 57%of surgical processes and recovery time, saving about 33%of potential costs.
Based on the obvious clinical advantages of ultrasound in the cardiac cavity, we expect it to be one of the biggest winners behind the rapid development of the heart electrical and structural heart disease industry.
70 years of exploration and innovation, the internal ultrasound of the heart cavity moves from 2D to 3D
As early as 1956, some researchers explored the "catheter+ultrasound technology" to the heart composition of the heart. However, based on technical restrictions, the exploration at that time was not successful.
Until 1980, ultrasound imaging technology and catheter intervention technology achieved breakthroughs, the ultrasound in the heart cavity was first applied. However, the first ultrasound of the heart cavity of the first application has a high frequency of transducers. It is 20-40MHz. The tissue penetration capacity is limited, making it unable to obtain an anatomical diagram in the heart. Nevertheless, the application of ultrasound in the cardiac cavity has greatly increased the confidence of researchers, and also laid the foundation for the subsequent research and development and innovation of the product.
Since then, some researchers have developed a low -frequency conversion (9MHz) to make it imagine the internal structure. However, these systems still have pain points such as low catheter flexibility, low imaging depth, and cannot be fully observed.
In 1990, innovative enterprises used lower frequencies (5MHz) to optimize the depth of imaging in the heart cavity. It is a pity that the corresponding converter limits the clinical application of the product due to large size.
With the innovative development of ultrasound phase control arrays, ultrasound in the heart cavity ushered in development opportunities. The phase control array technology is applied to the internal ultrasound field, which not only solves the problem of large transducers size, but also expands the scope of clinical applications in the intrapicpense system in the cardiac cavity. In simple terms, based on ultrasound phase control arrays, the imaging of the ultrasound in the heart cavity is deeper and the image is clearer. At the same time, ultrasound in the heart cavity can also provide a variety of imaging information, such as color blood flow, tissue Doppler, and spectrum Doppler.
In addition, ultrasonic converters also realize miniaturization, so that the rotating heart cavity ultrasound can also be widely used in clinical clinical. The rotating heart cavity intraocular ultrasound and phase control array of the heart cavity cavity in the heart cavity cavity cavity cavity cavity. The two have their own advantages and their own characteristics. Provide a variety of information such as anatomical structure, color blood flow Doppler, and spectrum Doppler. At present, the application of phase control arranges in the heart cavity is more widely used, occupying a dominant position.
At the beginning of the 21st century, Siemens Medical launched the first two -dimensional intraocular intraocular ultrasonic catheter ACUSON ACUNAV, which was initially used to guide rooms to puncture. Through the ultrasound in the heart cavity, doctors can obtain room interval images and measure the size of the room septal defect; it can be judged that the room septal defects and the position relationship of the aorta, two -pointed, valve, upper and lower cavity veins and other structures can be judged. Division puncture and other surgery are more accurate and safe.
Based on the advantages of structural heart disease in this product, it was subsequently expanded to use a variety of operations such as room septal blockage and left -hearted ear sealing.
With the widespread application of ultrasound in the heart cavity, its performance is gradually optimizing. In the past, ultrasound in the heart cavity has changed from two -dimensional imaging to three -dimensional imaging, which greatly enhances the ability to guide and visualization. The two -dimensional intraocular ultrasound supports dual or three -plane imaging, which can display two or three different plane views, but doctors need to rebuild these images into a three -dimensional anatomical structure in their minds. The three -dimensional intraocular ultrasound can directly present a three -dimensional anatomical structure, which is convenient for doctors to perform surgery easier.
In recent years, Siemens, Johnson & Johnson and other companies have innovated real -time three -dimensional heart cavity ultrasound system. If the two -dimensional heart cavity is used as a black and white TV, then the real -time three -dimensional heart cavity ultrasound is a 3D IMAX movie. Compared with the two -dimensional heart cavity ultrasound, the newly launched real -time three -dimensional heart cavity in the heart cavity can not only imagine real -time imaging, but also show information such as three -dimensional structure and blood flow of the heart, and the images presented are clearer and more accurate. According to the direction of product development, we expect more and more intra -hearty ultrasound systems to develop from two -dimensional development to three -dimensional real -time real -time imaging. At the same time, ultrasound in the heart cavity will also develop in clearer, accurate, multi -function and other directions.
The domestic market exceeds 10 billion, the annual usage of ICE will surge rapidly
From the perspective of application scenarios, ultrasound ultrasound can be used for atrial fibrillation, left heart -seal blocking, room septal defect blockage, two -pointed valve formal surgery, and endometrial myocardial biopsy. Fresh fiber, congenital heart disease, heart -derived stroke, room septal defect, two -pointed valve stenosis, triple valve narrowing, aortic valve stenosis, etc.
According to the Fifrrishalvan report, in 2021, there were about 133,400 patients with congenital heart disease in my country, about 4.5 million patients with heart -derived stroke, about 3.9 million patients with aortic valve reflux, and about 4.4 million patients with aortic valve stenosis About 5.9 million patients with two -pointed stenosis, and about 10.8 million patients with valve reflux. At the same time, a epidemic survey completed by the People's Hospital of Wuhan University found that there were nearly 20 million patients with atrial fibrillation in my country. From a global perspective, there are about 1.7 million patients with psychological diseases around the world, about 19.7 million patients with heart -based stroke, and about 220 million patients with valve diseases worldwide.
It can be seen that the patients with ultrasound associated with the heart cavity are extremely large, and huge demand will bred a huge market. At present, the ultrasonic catheter in the market is about 20,000 yuan/root. If it is calculated at a 10%penetration rate, the market space of the intraocular cavity in my country will exceed 10 billion yuan. About 1 million per unit system in the heart cavity is about 1 million/units. If only one three -level hospital is equipped with a host (not included in non -triple hospitals), the market space of the ultrasound host in the heart cavity will exceed 1.4 billion yuan.
Although the ultrasound in the heart cavity has broad prospects, it is still in the early stages of development.
According to the latest "China Structural Heart disease Industry Report 2021", in 2021, more than 6,500 cases (excluding clinical studies) of the aortic valve (excluding) of my country's reciprocal pipelines (excluding clinical studies), and the two -pointed valve edge of the Conduct For 350 cases, about 14,000 left -hearted ear sealing, about 75,000 cases of concentrated heart disease intervention surgery. "China Cardiovascular Health and Disease Report 2021" shows that the amount of Fangbi radio frequency melting surgery in my country in 2020 was about 35,000 cases.
As of now, the penetration rate of structural heart disease intervention in my country is still at a lower level, which has also made the internal ultrasound product used for structural heart disease intervention surgery less use.
However, experts believe that the intervention treatment of structural heart disease is far from reaching the platform period, and it will be rapidly popularized and promoted to increase the penetration rate. This is because the two -pointed valve circulation of domestic innovation enterprises, the three -pointed valve forming ring, the catheter intervention of the valve replacement product, the vein three valve triple valve repair equipment and other treatment of structural heart disease have been approved. Related enterprises are increasing market education and academic promotion.
According to the Fifrrishalvan report, the size of my country's structural heart disease intervention instruments has increased from 400 million yuan in 2017 to 2 billion yuan in 2021, with a compound annual growth rate of 48.3%. 10.4 billion yuan, a compound annual growth rate of 51%.
Based on the compound annual growth rate of nearly 50%of structural heart disease intervention in the market, ultrasound in the cardiac cavity is expected to grow at high speed. At the same time, the ultrasound market in the heart cavity will continue to expand with the rapid application of atrial fibrillation.
Solving clinical unreasonable needs,
ICE guidance surgery is more accurate
With the improvement of residents 'economic level and the improvement of patients' demand for precise treatment, ultrasound in the heart cavity will gradually become a need for just needed products.
Earlier, there were esophageal ultrasound (Tee) and ethical echocooth (TTE) clinically. Compared with the Tee, the ultrasound operation of the heart cavity can be flexible, which can be used to make it more accurately to check thrombus and guide surgery. TEE requires general anesthesia for special groups. Using ultrasound in the cardiac cavity only needs to be hemp. It also avoids the uncomfortable experience of esophageal intubation and the mechanical damage and heat damage of the Tee probe on the mucosa of the esophagus wall.
Compared with the mixture of the chest ultrasound (TTE), the ultrasound in the heart cavity is not affected by factors such as obesity, emphysema, and thoracic deformity, which can achieve shorter distance and higher precision imaging.
In addition, compared to traditional methods such as TEE, the intra -heart cavity ultrasound can monitor the risk of potential complications such as thrombosis and pericardial efficiency in the pericardium in real -time monitoring of the heart cavity to improve the safety of surgery. The department and anesthesiologist, the surgery arrangement is more flexible, and it can also reduce the cost of the personnel, improve the efficiency of surgery, and reduce all aspects of the surgery.
Clinically, TEE has always been a gold standard for the left atrium and left heart thrombus before the left -hearted duct discharge of atrial fibrillation or left -hearted ear seal. Some clinical data show that the intraocular cavity ultrasound and TEE evaluate the accuracy of left heart thrombus are equal, and the quality of the ICE's image is higher. In terms of diagnosing the effectiveness of the left cardius thrombosis, the intraocular cavity is better than Tee.
At the same time, the ultrasonic catheter in the heart cavity scan layer by layer from one end to the other end, which can fully display the maximum caliber of the axial direction of the left heart, the diameter of the landing area, and the effective work depth of work, so as to guide the choice of the blocking device more accurately. Multi -center studies have found that ICE's guidance of left -hearted ear sealing has less time and higher surgery efficiency, and the cost of anesthesia and ultrasound professionals has been significantly reduced. In terms of atrial fibrillation, the intra -heart cavity ultrasound has long been applied to atrial fibrillation catheter ablation. Compared with traditional X -ray images, an ultrasound in the heart cavity can replace or partial replacement X -ray images, reduce ray exposure, and can clearly and accurately identify the dirty situation of the center of the technique.
According to a statistical data for patients with nearly 300,000 cases of atrial fibrillation in 2020, for 14 years of statistical data, the atrial fibrillation catheter ablation can significantly reduce the inpatient mortality rate in the heart cavity. The incidence rate can be reduced by 52%, and the number of hospitalization days can also be significantly shortened (ICE is hospitalized for about 4 days, and ICE is hospitalized for about 2 days).
Based on the precision surgery of the heart cavity, the risk is low, the complications are small, the hospitalization time is short, and the recovery is fast. Therefore, we expect it to apply a larger scale to the clinic.
Global equipment giants are connected vertically. How can domestic innovative companies break through?
As of now, global equipment giants Siemens, Philips, GE Medical, Johnson & Johnson, Abbott, Boston Science, etc. have all -outdoor ultrasound in the heart. Among them, Siemens, Johnson & Johnson, Philips and other companies have launched or developed 3D and 4D internal ultrasound products.
For example, Siemens has the latest ACUNAV Volume 4D ICE catheter approved by the FDA in 2022 to provide 2D, 4D cardiac image imaging, 2D, 4D color Doppler blood flow, and spectrum Doppler. Clinical experts said that the ICE catheter opened up the application scope so that patients who could not have a structural heart intervention before were treated, such as patients with esophageal ultrasound contraindications, patients with general anesthesia, and patients with three valve reflux.
Johnson & Johnson has developed a 4D heart cavity ultrasonic catheter NUVISION, which is still in the registration stage. According to the data, the NUVISION intraocular ultrasonic catheter can perform real -time ultrasound imaging, with a 90 ° × 90 ° vision, a penetrating depth of about 15 cm, and 2D and 4D color Doppler blood flow. In addition to NUVISION, Johnson & Johnson also launched a Soundstar (3D) ultrasonic catheter that provides real -time ultrasonic heart -mounted imaging and navigation.
It is worth mentioning that Johnson & Johnson and GE Medical cooperation, its NUVISION intraocular ultrasound duct supports uses the Vivid Ultra Edition ultrasound system of GE Medical. At the same time, Johnson & Johnson also reached a cooperation with GE Medical in 2021 to jointly create the overall solution of the green catheter room, and each provides advantageous products, so that the atrial fibrillation of the audioxisa is safer and more accurate.
In addition, Philips also cooperates with Abbott. The ViewFlex Xtra ICE catheter launched by Abbott can be used with Philips's CX50 XMatrix ultrasound system.
In addition to these multinational weapons companies, innovative companies are also actively breaking through. For example, the innovative company, which incubated in medical research institutions, has been approved by the ForeSight ICE system in 2016, and the company cooperated with the Japanese listed company JAPAN LIFELINE in 2014 to distribute its ICE products exclusively in Japan by JAPAN LIFELINE; In 2017, he cooperated with the Chinese listed enterprise Yuanda Medicine to sell products such as ForeSight Ice exclusive in China. With the power of listed companies such as JAPAN LIFELINE and Yuanda Pharmaceutical, it is expected that the ForeSight ICE system of Conavi will be quickly applied.
In China, there are currently four main ICE products that have been listed, which are provided by Siemens, Boston Science, Johnson & Johnson, and Abbott. However, innovative companies such as Tingsheng Technology, Saihe Medical, Bingjing Intelligence, and Xinhuan Technology have also begun to actively develop ultrasound in the heart cavity, and have made breakthrough progress.
For example, Tingsheng's scientific and technological layout has developed a two -dimensional intraocular ultrasound and 4D ICE products. The former is mainly used for simple structural heart disease and electro -physiological surgery; the latter is mainly used for complex structural heart disease and electro -physiological surgery. The cooperation between the two will meet the needs of most structural heart disease and electrical physiology. In early March 2022, Tingsheng Technology successfully completed the first exploration of localized human clinical trials of the localization ICE, achieving a breakthrough in domestic ICE.
For innovative enterprises such as Tingsheng Technology and Saihe Medical, on the one hand, ultrasound, structural heart disease, and atrial fibrillation ablation in the heart cavity are in the early stage of development, the penetration rate is low, and there is still great room for development; however On the other hand, well -known world -renowned weapon companies actively deploy ultrasound in the heart cavity, which will bring huge competitive pressure to enterprises.
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