Special balloons, as an important vascular interventional medical device, can better focus the inflation and extrusion stress of the balloon by attaching metal or other material cutting pieces to the working surface of conventional balloon dilation catheters. This not only effectively dilates narrow blood vessels but also reduces risks such as residual stenosis and vascular dissection. China's research and development strength in special balloons has rapidly increased in recent years, and the speed of product launch has accelerated, promoting the process of domestic substitution for imports. As of January 2024, among the more than 30 special balloon products approved for marketing by the NMPA, domestic special balloon products account for about 50%, including cutting balloons, directional embossed balloons, guide wire embossed balloons, spiculated balloons, mastoid balloons, peripheral constraining balloons, embossed drug-coated balloons, etc., covering the fields of coronary and peripheral vascular interventional treatment. Special balloons have gradually developed from adjuvant treatment to the main treatment method in multiple indications due to their excellent capabilities, providing better options for more patients with vascular stenosis diseases.
On March 5th, Frost & Sullivan (hereinafter referred to as 'Frost & Sullivan') officially released the 'Blue Book on the Current Situation and Development Trends of the Vascular Interventional Special Balloon Industry' (hereinafter referred to as the 'Blue Book'). The report analyzes the current situation of the vascular interventional special balloon industry, providing a comprehensive exposition from dimensions such as technological development, application areas, marketed products, and capital interest. It tracks the development context of the industry and technology, explores the huge potential for industry development, analyzes market development trends, and aims to provide a reference for participants and stakeholders in the field of vascular interventional special balloons.
1
Overview of the Vascular Interventional Medical Device Industry
1.1
Overview of Vascular Diseases
Vascular disease is a series of circulatory system disorders characterized by vascular pathology, involving arteries, veins, and lymphatic vessels. Vascular diseases affect blood flow by blocking, thinning the vessel wall, and destroying venous valves, which can endanger important organs such as the heart, brain, kidneys, limbs, and large arteries. The main risk factors for arterial disease include hypertension, diabetes, hyperlipidemia, smoking, obesity, etc. The main pathological change is atherosclerosis, which occurs due to the formation of lipid streaks, fibrous plaques, or atherosclerotic plaques in the vascular intima, leading to secondary plaque hemorrhage, rupture, thrombosis formation, aneurysm rupture, and sclerotic stenosis of the affected large arteries and medium arteries.
Source: Analysis by Frost & Sullivan
1.2
Overview of Epidemiology of Vascular Diseases in China
The prevalence of cardiovascular diseases in our country is on the rise, and the disease burden continues to grow. Data from the 'China Health Statistics Yearbook 2022' show that in 2021, the mortality rate from heart disease among urban residents was 165.37 per 100,000, while that among rural residents was 188.58 per 100,000, both ranking first among all causes of death; in 2021, the mortality rate from cerebrovascular disease among urban residents was 140.02 per 100,000, ranking third among causes of death, while that among rural residents was 175.58 per 100,000, ranking second.
The 'China Cardiovascular Health and Disease Report 2022' indicates that, according to calculations, the number of people suffering from cardiovascular diseases (CVDs) in China in 2019 was 330 million, including 11.39 million with coronary heart disease, 45.3 million with peripheral arterial disease, and 13 million with stroke. At the same time, the report points out that the number of deaths from atherosclerotic cardiovascular diseases (ASCVDs) in China has shown rapid growth. From about 1 million in 1990, which accounted for 40% and 11% of CVD-related deaths and total deaths respectively, it increased to 2.4 million in 2016, increasing the proportion of CVD-related deaths to 61% and total deaths to 25%.
1.3
Advantages of interventional therapy
Interventional therapy has developed rapidly and is listed alongside traditional internal medicine and surgery as one of the three major clinical techniques. Vascular interventional therapy has significant advantages, combining the strengths of imaging diagnosis with minimally invasive treatment. It features minimal trauma, accurate positioning, high efficacy, quick results, a wide range of indications, few complications, and rapid postoperative recovery. It is an important treatment method for vascular diseases; compared to surgical operations, it does not require incision to expose the lesion, has a lower risk of postoperative infection, and shorter hospital stay. It mainly uses local anesthesia or intravenous anesthesia, with low anesthesia risks.
Park et al. published a literature article in the journal Circulation titled 'A 10-year follow-up study of 600 patients with left main coronary artery disease without three-vessel disease' (PRECOMBAT). They found that patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents did not show significant differences in all-cause mortality, myocardial infarction, and stroke compared to patients undergoing coronary artery bypass grafting (CABG).
A meta-analysis published by Yousif et al. in the European Heart Journal on PCI and CABG showed that for left main coronary artery lesions, there was no significant difference between PCI and CABG in terms of all-cause mortality risk (P=0.779), cardiac mortality risk (P=0.817), stroke risk (P=0.400), or myocardial infarction (P=0.110).
The 'Blue Book' sorts out the definition and classification of vascular diseases, the global and Chinese cardiovascular disease burden, the advantages of interventional treatment and its annual volume of surgeries over the years, as well as relevant policies on vascular interventional medical devices. For more detailed content, please refer to the full report.
2
Special Balloon Treatment Industry Overview
2.1
Definition and Function of Balloon Dilation Catheter
Balloon dilatation catheters, commonly referred to as balloons, are a commonly used vascular interventional treatment consumable. After reaching the vascular lesion, they can be inflated and expanded through the balloon to squeeze the blood vessel and achieve the purpose of dilating the narrowed blood vessel. Balloon dilatation catheters are of significant value in clinical vascular interventional treatment, including dilating narrowed blood vessels, delivering stents and expanding stents, and occluding blood vessels.
2.2
Introduction to Special Balloons
Special balloons are based on conventional balloon catheters, with additional cutting elements attached to the surface of the balloon or protrusions made on the working surface. When the balloon is inflated and expanded, the cutting elements or protrusions that project from the surface of the balloon focus and transmit pressure to the inner wall of the blood vessel, achieving the purpose of cutting the vascular endothelium and dilating stenotic blood vessels. Special balloons use cutting elements or protrusions to obtain greater cutting force and a more uniform cutting surface, thereby more effectively dilating stenotic blood vessels, reducing irregular tearing of blood vessels, and lowering the risk of dissection.
Ordinary balloon dilation catheters cause uneven stress on the vessel wall during blood vessel dilation, leading to plaque extrusion and tearing, as well as risks of vascular injury such as dissection. They are difficult to handle in cases of calcification or fibrosis, and are prone to elastic recoil. Special balloons equipped with cutting pieces or protrusions gather the extrusion force generated by balloon dilation and transmit it to the inner wall of the contact vessel, enabling enhanced cutting force and directional uniform incision of plaques. This achieves effective blood vessel dilation, reduces elastic recoil, plaque migration, and vessel stretching.
Source: Analysis by Frost & Sullivan
2.3
Analysis of Cutting Parts for Special Balloons
Special balloon cutting pieces include blades, guide wires, spurs, and coil springs. The material, shape, height, and quantity of the cutting pieces can all affect the vasodilation effect. Generally speaking, metal cutting pieces are harder and more likely to cut through calcified vascular lesions; sharp cutting pieces generate greater stress than blunt ones, making them easier to penetrate the intima and achieve uniform tearing; the higher the cutting piece's height, the deeper it cuts into the tissue, resulting in better dilation effects; carrying too few cutting pieces is not conducive to uniform and effective vasodilation.
Source: Public information, Frost & Sullivan analysis
The 'Blue Book' analyzes dimensions such as balloon-expandable catheters, definitions and classifications of special balloons, analysis of special balloon parameters and performance evaluation, and the development history of special balloon technology. For more detailed content, please refer to the full report.
3
Special coronary balloon
3.1
Percutaneous coronary intervention (PCI)
PCI is a minimally invasive procedure for treating coronary artery disease. It uses a PTCA catheter to enter the coronary arteries through peripheral blood vessels in the arm or leg, and then inflates and dilates the blood vessels at the site of coronary stenosis or blockage with a balloon. PCI technology is applicable in many clinical scenarios, including: 1) Patients with stable angina who do not respond well to drug therapy; 2) Patients with unstable angina or asymptomatic ischemia but at high risk of heart disease; 3) Acute coronary syndrome, including unstable angina, non-ST-segment elevation myocardial infarction (NSTEMI), or ST-segment elevation myocardial infarction (STEMI). PCI surgical treatments mainly include percutaneous transluminal coronary angioplasty (PTCA) and stent implantation (CSI).
3.2
Special coronary balloon and indications
Special coronary balloons are based on conventional coronary balloons and usually carry 1-4 cutting elements. Special coronary balloons, with their attached cutting elements, can significantly increase the extrusion stress at the contact area between plaque and cutting elements, thereby tearing the plaque evenly and directionally. They can open hard lesions such as severe calcified lesions, offering better dilation effects and a lower incidence of vascular risk events. According to the 'SCAI Position Statement on Optimal Percutaneous Coronary Interventional Therapy for Complex Coronary Artery Disease', scarred balloons and cutting balloons are recommended for in-stent restenosis lesions (caused by intimal hyperplasia), calcified lesions, etc. In addition, open and bifurcated lesions, small vessels, and fibrotic plaques are also important indications for special balloons.
3.3
Approval status of special coronary balloons in China
The market for special coronary balloons in China has developed rapidly. After 2020, several domestic special balloon products were successively approved. As of January 2024, there were a total of 14 special balloon products approved for marketing by the NMPA (counted by registration approval number), including 8 domestic and 6 imported coronary balloons. The currently approved special coronary balloons include cutting balloons, spiculated balloons, emboic balloons, directional scoring balloons, and guidewire scoring balloons.
The 'Blue Book' focuses on the special balloon segment of coronary artery intervention, analyzing the basic characteristics of coronary diseases, unmet treatment needs, and the iterative development of coronary interventional treatment technologies. It introduces special coronary balloons and elaborates on their advantageous features and potential clinical challenges that can be overcome. The 'Blue Book' sorts out the already marketed special coronary balloon products in China, introduces different types of special coronary balloon products and their clinical data, and analyzes their future development trends. For more detailed content, please refer to the full report.
4
Peripheral vascular special balloon
4.1
Balloon-expandable catheter treatment of peripheral vascular diseases
Peripheral arterial balloon dilation catheters can be used for peripheral artery diseases such as iliac arteries, femoral arteries, iliofemoral arteries, popliteal arteries, infrapatellar arteries, renal arteries, carotid arteries, and other peripheral arteries. They are also indicated for venous diseases such as iliac veins and portal veins, as well as obstructive lesions of autologous or artificial arteriovenous dialysis fistulas. They have become an important treatment method for peripheral vascular diseases.
Source: Public information, Frost & Sullivan analysis
4.2
Indications for peripheral special balloons
Peripheral special balloons are similar to coronary special balloons, also focusing extrusion stress by attaching cutting pieces to the balloon surface to achieve better dilation of narrowed peripheral blood vessels. Compared to coronary special balloons, peripheral special balloons typically have a diameter of 2-8 mm and a length of 15-300 mm, offering more specification options to better adapt to complex peripheral vascular stenosis conditions. Special balloons have been recommended by multiple expert consensus or guidelines for the treatment or adjunctive therapy of peripheral vascular stenosis lesions:
"Expert Consensus on Vascular Access for Hemodialysis in China (2nd Edition)":It is recommended to choose special balloon treatment for the stenosis of autologous arteriovenous fistulas;
SCAI consensus guidelines for device selection in femoral-popliteal arterial interventionsIt is noted that the special balloon is an adjunctive treatment device for femoropopliteal artery disease and can be used as an adjunct in total femoral artery, supracondylar popliteal artery, superficial femoral artery, and in-stent restenosis lesions. It is particularly recommended for moderate to severe calcified, non-expandable focal/medium/severely diffuse lesions; the guideline recommendation level is IIA;
"Chinese Expert Consensus on the Diagnosis and Management of Renal Artery Stenosis":For patients with non-atherosclerotic renal artery stenosis (RAS) caused by Takayasu arteritis, if PTA is unsuccessful (the lesion immediately recovers elastic recoil or dissection after balloon dilation, and the lesion is hard and difficult to fully dilate), a cutting balloon can be selected for treatment. For atherosclerotic RAS, a stented cutting balloon can be used as a pretreatment device before stent implantation.
4.3
Approval status of Chinese peripheral special balloons
As of January 2024, there are a total of 17 peripheral special balloon products approved for marketing by the NMPA (counted by registration approval number), including 8 domestic and 9 imported peripheral special balloon products. The currently approved peripheral special balloons include cutting balloons, directional incised balloons, guidewire-incised balloons, incised drug-coated balloons, and peripheral constraining balloons.
The 'Blue Book' focuses on the field of peripheral special balloons, analyzing the types, basic characteristics, main treatment methods, market size, and volume of interventional surgeries for peripheral vascular diseases. It conducts an analysis centered around peripheral special balloons, covering aspects such as product types and features, approval status in China, clinical data, and future development trends. For more detailed content, please refer to the full report.
5
Special Balloon Industry Capital Market Performance
The 'Blue Book' sorts out the performance of medical device R&D companies in the primary market that are deploying vascular interventional balloon portfolios, as well as collaborative R&D or commercialization events disclosed in recent years. For more detailed content, please refer to the full report.
