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About coronary stents

2023/08/25

Introduction to coronary stents

Coronary stents are mainly used in coronary angioplasty, also known as percutaneous coronary intervention, which is a procedure used to open blocked arteries in the heart. The stent looks like a tiny wire mesh ring that supports the artery wall and helps prevent it from narrowing again after angioplasty.

(Data source: CNKI)

Stand placement steps:

The first step is to disinfect the inside of the patient's wrist and then local anesthesia.

The second step is to carry out extensive disinfection of the entire forearm after anesthesia, spread a towel and other preoperative preparations.

The third step, the injection on the inside of the patient's wrist, generally selected puncture site is the radial artery, the needle will be slightly thicker than the needle of the infusion, mainly in order to successfully put the sheath and guidewire in the blood vessel, the sheath has two ends, one end in the blood vessel, one end in the blood vessel.

In the fourth step, the finger guide wire and a thin guide wire are sent through the outside of the sheath to the coronary opening of the heart, and then the balloon and stent are placed to the location where the designed blood vessel needs to be dilated.

The fifth step is to inflate the balloon, and immediately after the inflated balloon opens the stent, the gas in the balloon is withdrawn to deflated the balloon, at this time, the stent will still stick to the blood vessel wall like an umbrella to support the narrow blood vessel.

(Source: CNKI)

Classification of coronary stents:

1. Ordinary metal bare bracket: it is divided into stainless steel bracket, nickel bracket, titanium bracket, tantalum bracket and cobalt-chromium alloy bracket. Bare metal stents are stents that are not drug-coated. The advantage is that patients take dual antiplatelet drugs for a short time after surgery, and the disadvantage is that the incidence of restenosis is higher.

2. Drug-coated stents: The drug in them is released slowly to help prevent plaque buildup and narrowing of blood vessels again in the future. After the stent is placed, the doctor will prescribe medication to reduce the chance of blood clots forming on the stent.

3. Bioresorbable degradable scaffold: It is made of materials that can be dissolved in the human body, and after being put into the body, it can be absorbed by the human body. However, studies have shown an increased risk of device-related thrombosis in patients with bioresorbable vascular stents, limiting its clinical use.

(Source: Essence Securities)

Coronary stent market

In 2022, the global coronary stent market size reached 591.87 billion yuan (RMB), according to the forecast of Begers Consulting, the global coronary stent market size will grow to 2028.1029 billion yuan in 29, and the CAGR will reach 2022.2028% during the forecast period of 9-64.

From the perspective of market size, China's coronary stent market size reached 2017 billion yuan in 130, CAGR = 2013% from 2017 to 15, according to a rough estimate of 15% growth rate, China's PCI stent market size is expected to reach 2022 billion yuan by 250.

In terms of degradable stents, although affected by the withdrawal of Abbott degradable stents, degradable stents are still being developed by many companies as the next development direction of coronary stents; We expect that in the future, degradable stents will not completely replace metal brackets, but they will occupy a large market share.

(Global biodegradable scaffolds potential market size)

Coronary stent main player

(Source: Sino Medical Prospectus)

Minimally Invasive Medical (00853) – Firehawk

The Firehawk Coronary Rapamycin Targeted Elution Stent System (TES) is the world's first and only targeted eluting stent system. This product is a new generation of minimally invasive products after Firebird and Firebird2 for the treatment of lesions such as coronary artery stenosis or obstruction. Using the TES Technology platform, the coating exposure area is only 20% of the surface area of the stent, the drug release time in vivo exceeds 90 days, the polymer coating is completely degraded within 9 months, and the average metal coverage is 14.0-16.1%. This stent is the world's lowest drug load stent, which is 1/3 of the drug volume of similar products, and can achieve the same effectiveness.

（来源：官网截图）

Lepu Medical (300003. SZ）——NeoVas

NeoVas is the first bioresorbable stent approved for marketing in China, after implantation in the human body, after three stages of revascularization, stent degradation and absorption and vascular repair, it is finally completely degraded, and the structure and function of blood vessels are restored. It can avoid the very advanced safety risks caused by the permanent retention of metal stents in the body, restore the elastic and contractile function of blood vessels, realize the leap from "vascular recanalization" to "vascular reconstruction", and enable patients to get greater and more benefits throughout the life cycle. The bracket adopts a stainless steel platform with a thickness of about 91 μm, and there is no polymer coating, but a large number of nanoscale holes are made in the wall of the bracket to fill 2.2 μg/mm2 of rapamycin. In real-world registry studies, the incidence of TLF 1 year after Nano+ stenting was 3.1%, with stent thrombosis occurring in only 0.4% of patients. No data were found for longer follow-up.

(Source: Official website screenshot)

Gateway Medical (a subsidiary of Parksun International acquired by Bluesail Medical) - Excrossal

Jiwei is the third domestic brand independently developed coronary stent listed, followed by Lepu and MicroPort at the end of 2005 to obtain the registration certificate of Excel stent, stainless steel skeleton (120μm thick) with degradable coating, occupying about 20% of the market share, in the real world, the incidence of postoperative MACE is also low, 1.2% in 7 year, 18.3% in 1 months after surgery. SUBSEQUENTLY, JIWEI MADE DESIGN IMPROVEMENTS ON THE BASIS OF EXCEL, WHICH IS NOW THE EXCROSSAL BRACKET THAT HAS ENTERED THE CENTRALIZED PROCUREMENT, COMPARED WITH THE GENERATION OF EXCEL BRACKET, THE EXCROSSAL HEART LEAP BRACKET HAS BEEN UPGRADED IN TERMS OF MATERIALS, STRUCTURE, DOSAGE AND MANUFACTURING PROCESS. RESULTS OF FOUR YEARS OF FOLLOW-UP SHOWED THAT THE EXCROSSAL HEARTBEAT STENT HAD A LOWER TARGET LESION FAILURE RATE (TLF) AND A PATIENT-DRIVEN COMPOSITE ENDPOINT EVENT (POCE) RATE, AND A BETTER SAFETY PROFILE. EXCROSSAL ALSO HAS SIGNIFICANT ADVANTAGES IN REVASCULARIZATION AND ISCHEMIA-DRIVEN TVR.

(Source: Official website screenshot)

Sino Medical – BuMA

BuMA drug-eluting scaffolds (DES) have an eG coating and a biodegradable PLGA drug carrier. The design of the double membrane coating can not only inhibit the proliferation and migration of smooth muscle cells to the greatest extent, but also minimize the impact on endothelial cell structure and function repair. This early functional healing allows for BuMA stents; At the same time, the company has a fully degradable magnesium alloy coronary drug-eluting stent system under development, which has entered exploratory human clinical research in 2021.

(Source: Official website screenshot)

The investment research team of XinValue believes that coronary stent is the most important segment of implantable stents, accounting for more than half of China's implantable stent market. The localization rate of the most mature coronary stent in domestic stents has reached about 80%, basically completed import substitution, the domestic market competition pattern is relatively stable, the current research in the field of stents is mainly focused on the fourth generation of fully degradable stents. In the future coronary stent market, only products with a wide range of indications, safety, efficacy and controllability, and even filling the gap in the world can stand out.

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