The development trend of balloon

The development trend of balloon in the field of vascular intervention

Interventional therapy is a treatment method between surgery and internal medicine. It is to make tiny channels with a diameter of several millimeters in blood vessels and skin without surgery to expose the lesions, or through the original pipelines of the human body, in imaging equipment (Angiography machine, fluoroscopy machine, CT, MR, B-ultrasound) guide the treatment of local lesions with minimal trauma. Following traditional medical treatment and surgical thoracotomy treatment, interventional therapy has created a new field of modern medical treatment with its advantages of small interventional trauma, low surgical risk, and obvious curative effect.

Vascular intervention is a medical field that we all often come into contact with. Commonly used equipment mainly includes: catheters, guide wires, balloons, stents and stent grafts, filters, and various puncture devices, etc. Today, Shunhao will take you to understand Under the current vascular intervention field, the application situation of balloon products and the development direction of the future market.

Coronary balloon

PCI surgery is currently the mainstream therapy for coronary heart disease, and the technology and products are also very mature after long-term development. At present, the number of patients with coronary heart disease in the country is estimated to exceed 10 million, and the number of PCI operations is growing rapidly. Compared with the number of PCI operations per million people in China and developed countries, there is still more than twice the market development space in China.

Coronary interventional therapy has undergone 4 technological innovations: the first generation of balloon expansion (POBA), which uses balloons to inflate the coronary artery stenosis to improve blood circulation. However, restenosis is prone to occur after balloon expansion, and the balloon Balloon expansion can easily lead to vascular tears; the second-generation bare metal stent (BMS) uses a balloon to expand the coronary artery while placing a bare metal stent to provide mechanical support. However, as a foreign body, metal stents can stimulate blood vessels. In addition, the placement process can easily cause damage to the blood vessel wall. The third-generation drug-eluting stent (DES) is the current mainstream coronary stent, and the drug coating on the surface of the stent will be slowly released. , In order to inhibit the proliferation of intravascular tissue, thereby preventing the occurrence of restenosis in the stent; the fourth-generation biodegradable stent (BRS), the biodegradable stent is implanted for a period of time to mechanically support the narrow coronary blood vessels, At the same time, drugs are released to prevent blood vessel restenosis, and eventually the stent will be absorbed by the body, achieving the effect of “intervention without implantation”.

Regarding the choice of coronary balloons, semi-compliant balloons are usually referred to as pre-expanded balloons in clinical practice, which are mainly used for pretreatment of lesions; non-compliant balloons are called post-expandable balloons, which are mainly used as stents. Post-expansion treatment after implantation. However, if the lesion is hard and low pressure is not easy to fully expand, you can consider using non-compliant balloons for lesion pretreatment to avoid the “dog bone effect” of semi-compliant balloons during high pressure expansion (below). Cause excessive damage to normal blood vessels. When the non-compliant balloon cannot fully expand the lesion, it is necessary to consider the use of a special balloon. The common feature of these types of balloons is that the plaque is formed locally by the blade, nylon wire or guide wire protruding from the surface of the balloon. Cracks make it easier for the plaque to be fully expanded.

In the medium and long term, the drug eluting balloon (DCB) may become a key breakthrough for domestic enterprises. The drug-eluting balloon is an emerging technology product. It expands the blood vessel through a special balloon coated with a drug on the surface, and evenly spreads the drug on the blood vessel wall, so as to solve the patient’s vascular stenosis problem without implanting a stent. Compared with DES, drug balloons have many advantages, such as strong vascular adaptability, low thrombosis risk, and ability to cope with in-stent restenosis. Due to the high technical barriers to drug balloons, currently only SeQuent Please from Braun, Pantera Lux from Bristol and DIOR from Eurocor in Germany have obtained CE certification for drug-coated balloons worldwide, while domestic brands have Dalian Yinyi and Shanghai Shenqi have been approved for listing. In addition, Lepu Medical’s Vesselin has been approved in July. It is expected that the penetration rate of drug balloons in PCI is expected to increase rapidly. At present, drug-eluting balloons have become a key research and development direction of domestic enterprises.

At present, the drugs contained in the currently marketed coronary drug balloons are paclitaxel. However, due to the large initial drug release rate of the fat-soluble paclitaxel, the small late stage drug release rate, and poor performance in calcified blood vessels, rapamycin can be more effective than paclitaxel. It promotes the repair of damaged blood vessels, and the drug release rate is stable. At present, various manufacturers have begun to develop rapamycin-containing drug balloons. Lanfan Medical’s rapamycin drug balloon has been clinically enrolled in March 2020 and is expected to be approved in mid-2021; Lepu’s third-generation rapamycin drug balloon has also entered the development stage.

Peripheral balloon

Peripheral arterial disease is a disease symptom that affects the blood supply to the body in the distal arteries of the limbs. The arteries transport blood from the heart to various parts of the body. As the cholesterol level in the arteries rises and scar tissue is formed, the peripheral arteries will be narrowed and the limbs will be insufficiently supplied with blood.

Currently, the two main non-surgical treatments for peripheral arterial occlusion are balloon angioplasty and peripheral arterial stent placement. Percutaneous angioplasty selects balloons of different sizes, shapes, and delivery system lengths according to the patient’s condition. Peripheral arterial stents are divided into ball-expandable stents and self-expanding stents. Ball-expandable stents are mainly used in blood vessels that do not have obvious deformation (such as renal artery); self-expanding stents are currently the most commonly used stents in peripheral interventional therapy. Generally, laser engraving of nickel-titanium super-elastic alloy tubes is used, and plastic deformation will not occur in a small sheath.

Peripheral arterial balloons are usually used for pre-expansion, and the marketed drug balloons partially replace the role of stents, which can avoid postoperative vascular elastic retraction, stent fracture, intrastent restenosis and other clinical complications, and the growth rate is increasing. In the peripheral arterial intervention balloon market, imported products account for more than 95% of the overall market share. In the market segment, Medtronic still occupies the leading position in the industry, and the number of Bard surgeries ranks second, in addition to Abbott and Boston Scientific.

In 2016, Senrida’s paclitaxel drug-coated balloon dilatation catheter was approved, becoming the first peripheral drug balloon to be marketed. Multinational companies such as Medtronic, Abbott, and Bard are also actively deploying drug-coated balloons. The minimally invasive heart and vein drug-coated balloon has become the second marketed product in China. In the future, competition in this field will become increasingly fierce. In addition, Xinmai Medical’s high-pressure balloon dilatation catheter has also entered the sample verification stage, and the product performance directly matches the benchmark product in the standard market.

Nerve intervention balloon

Neural intervention is an important part of interventional medicine. It is used for the diagnosis and treatment of cerebral blood vessels. It has the characteristics of great difficulty and wide range. According to different functions and indications, neurointerventional devices can be divided into access type, hemorrhage type and ischemia type. With the continuous development of the aging population, policy support, enriched promotion paths and other factors, the neurointervention industry continues to develop rapidly, with a compound growth rate of 29.70% from 2015 to 2018. We expect the market size to exceed 30 billion yuan in 2025. .

Intracranial atherosclerotic stenosis is an important pathological basis for ischemic stroke. For the interventional treatment of intracranial atherosclerotic stenosis, the arterial stent is generally delivered to the vascular stenosis through a balloon dilatation catheter or directly processed by a drug-eluting balloon. It is suitable for symptoms of ischemia and the degree of stenosis is greater than 50%. Of patients or patients who have no obvious symptoms but the degree of stenosis is greater than 70%.

At present, in the balloon market, foreign-funded products are dominated by Boston Scientific and Abbott, and their products have their own characteristics. It can be selected for different types of lesions according to the outer radius, flexibility, tracking, pushability, and compliance of the balloon product. The imported products are mainly Boston Scientific and Abbott, and their products have their own characteristics. Cordis’s balloon dilatation catheter has an ultra-small outer diameter, which is more conducive to passing through the tortuous blood vessels in the skull and is convenient for interventional treatment. Boston Scientific’s PTA balloon dilatation catheter has two radiopaque marker strips on the balloon, which can be used to assist the precise positioning of the balloon before expansion; Abbott’s balloon material has a 14atm burst pressure that can be flexibly adjusted in size. In terms of domestically-produced products, Sinoe has grown rapidly. Sino is the first rapid exchange balloon approved by CFDA for intracranial stenosis. It has a unique balloon necking technology that can reduce the damage to the blood vessels at both ends of the balloon.

Medtronic has a wide range of neurointerventional products. HyperGlide occlusion balloon catheter, a representative single product of the balloon, is suitable for peripheral blood vessels and nerve vessels that need to be temporarily blocked. These catheters provide a technique for selecting vessels for temporary vascular occlusion, and can also be used for balloon-assisted embolization of intracranial aneurysms.

Summary

The R&D and production of medical devices requires interweaving of various disciplines, low product homogeneity, complex treatment fields, and products with higher industry thresholds and longer life cycles. With the aging of the population and the prevalence of cardiovascular and cerebrovascular diseases, the number of vascular interventions will continue to increase in the future, and the clinical advantages of balloons will continue to be highlighted. We also look forward to making domestic high-quality enterprises bigger and stronger, bringing more high-quality and low-cost products to the majority of patients, and realizing the domestic replacement of interventional balloons.

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