There is a large market for arterial hemangioma stent development potential of small products can not be underestimated

Business Society August 26 thorax abdominal aortic hemangiomas are clinically common diseases. One of the rare cases is Marfan's syndrome (congenital ascending aortic hemangiomas), and the most frequently occurring disease is senile abdominal aortic hemangiomas. According to statistics, the incidence of thoracic-abdominal aortic hemangioma is approximately 3 in 100,000 in the United States, which means that more than 100,000 people in the United States are diagnosed with thoracoabdominal aortic hemangioma every year.

The so-called "hemangioma" refers to a particularly thin blood vessel wall, under the influence of strong arterial blood flow, where the blood vessel wall expands slowly, such as a globular shape. Once subjected to external forces or self-caused factors, the intravascular pressure suddenly increases. Hemangiomas often rupture, resulting in hemorrhage in the chest and abdomen, and endanger the lives of patients.

In general, the main causes of thoracoabdominal aortic hemangiomas are: 1. Congenital factors (such as genetic factors); 2. Acquired factors (such as hypertension caused by arteriosclerosis, smoking, or other unclear reasons Wait). At present, doctors can clearly detect the incidence of hemangiomas in patients using conventional electronic diagnostic imaging devices such as CT and B ultrasound.

Treatment of hemangiomas in the clinical medical community generally takes two approaches: 1. Thoracic (abdominal) surgery to remove hemangiomas; 2. Implantation of an aortic aneurysm stent. In recent years, the installation of aneurysm stents has been adopted by more and more hospitals. Because the risk of surgical failure of aortic aneurysms is larger, the best surgical success rate for aortic aneurysms at home and abroad is generally only 80% to 85%. In other words, 15% to 20% of patients with hemangiomas still die during surgery. Operating table. Now, the medical profession in Europe and the United States is more inclined to adopt “conservative therapies” – instead of surgery, stents are installed directly for patients with hemangiomas. For patients with hemangiomas who have not yet reached a dangerous level, installing stents can extend the patient's life.

Research and development

Inspired by the success of medical devices such as cardiovascular stents and coronary interventional therapies, some medical device manufacturers in the United States began to develop new stents for hemangiomas 10 years ago. Their idea is: to install a stent in the aorta, so that blood flow directly from the lumen of the stent, so that can greatly reduce the impact of arterial blood flow on the wall of the weak tumor blood vessels, play a preventive hemangiomas Cracked effect.

Hemangioma stent products on the market today are generally hollow tubes woven from platinum and other ductile metal wires, and are wrapped with a thin layer of chemical fiber “skin”. Basically all stents on the market are listed. For the above structure. The doctor passes the patient's inguinal artery, and the compressed stent is precisely placed under the guidance of an electronic diagnostic imaging instrument such as a CT or MRI. The balloon is used to stretch the stent against the blood vessel wall to protect the blood vessel wall. effect. This is how the aneurysm stent works. The advantage of using a hemangioma stent is that it can make the strong blood flow in the arterial blood vessel no longer impact the weak hemangioma wall and prevent the latter from accidentally breaking.

In recent years, U.S. manufacturers have successively developed and marketed several new hemangioma stent products that can support the function of blood vessel walls, including:

1. Inul Trak intra-abdominal hemangiomas stent newly developed by Endologix, USA. The product has been approved by the FDA and was listed in June this year.

2. The United States Cook medical device company developed a ZenithTX2 hemangiomas stent. The product has entered Phase III clinical trials. According to the manufacturer, the product uses an inner liner made of a highly elastic wire braid, and is coated with a hydrophilic film material, which is suitable for the implantation of patients with elevated aortic aneurysms. It is expected that the product will be listed within 1 to 2 years.

3.Talent abdominal aortic aneurysm stent. The product was developed by Meditronic, one of the two largest medical device companies in the United States. In 2008, it was approved by the FDA. It is a new kind of stent made of a high-strength synthetic fiber film wrapped in a hollow tube made of metal wire.

4. AneuRx hemangiomas stent. The product belongs to a kind of "minimally invasive" vascular stent, which is a new product of the second generation hemangioma stent developed by Meditronic, USA. Its characteristics are durable and can work in the body for a long time. The materials used are also superior to those used for the first generation of hemangiomas. It is expected that the product will be listed in the United States during the year.

5. Anaconda hemangiomas stent. Developed by Terrmo Corporation of Arizona, USA. According to reports, the stent has been clinically tested in 20 US state hospitals.

There are several new products for hemangiomas stents under development, but the product structure is similar. According to foreign media reports, US manufacturers have recently launched a new type of hemangiomas stent CAAS (brain artery hemangiomas stent) that can prevent the rupture of cerebral aneurysms. The product has been approved for listing in many countries in the United States, Japan and Europe.

market expectation

According to U.S. media reports, the new medical reform plan passed by the U.S. Congress in March this year will significantly increase sales of medical device products including stents for hemangiomas. This is because the cost of performing an arterial angioplasty stent graft operation together with the stent needs about 15,000 to 18,000 U.S. dollars. Therefore, the number of patients undergoing hemangiomas stent implantation surgery is not that much, and the new medical reform plan states that this The cost of surgery can be reimbursed by the government in large part, and the patient himself only has to bear a small proportion of the cost. The new medical reform plan will greatly promote the increase in the use of stents for arterial hemangiomas in the United States. Sources said that the total number of patients with thoracic and abdominal arterial hemangiomas diagnosed so far in the United States has reached 1.2 million. This is an amazing number. According to reports from experts of the American Circulatory System Society, patients 65 to 75 years of age in the United States account for a large proportion of cases of abdominal arterial hemangioma. For example, according to the new medical reform plan passed by the US Congress, most of the cost of installing stents for patients with arterial hemangioma can be reimbursed. In the next few years, the annual growth rate of the aneurysm stent in the US market will reach 13%, which means that in 2011, the annual sales of American arterial hemangioma stent will jump to 550 million US dollars. In Europe and Japan, stents for interventional treatment of arterial hemangiomas will also have broad market prospects.

Small arterial hemangioma stents are expected to become new generation of best-selling interventional devices, and their development potential cannot be underestimated.