Frost & Sullivan releases the 'White Paper on the Current Industry Situation and Future Development of the Neurointerventional Industry in China' (with full text available for download)

Interventional medicine is a discipline based on imaging diagnosis, using puncture needles, catheters, and other interventional equipment to treat diseases or collect histological, bacteriological, physiological, and biochemical data for diagnosis.

In terms of treatment areas, interventional medicine can be divided into vascular system interventional medicine and non-vascular system interventional medicine.

The Report details the definition, importance of interventional medicine, and the detailed treatment methods for vascular system interventional medicine and non-vascular system interventional medicine. For more detailed content, please refer to the full report.

Neurointerventional technology, also known as neurovascular interventional technology, refers to the technique of diagnosing or treating lesions in the head and neck and spinal cord through vascular or percutaneous puncture routes, supported by medical imaging equipment such as digital subtraction angiography (DSA) systems. Neurointerventional technology has a development history of nearly a hundred years, which can be roughly divided into three stages: early germination, rapid development, and innovative optimization.

Source: 'A Brief Overview of the Development of Neurointervention in China', Frost & Sullivan analysis

In recent years, the state has successively introduced relevant policies, starting from three aspects: medical device innovation, stroke diagnosis and treatment and prevention, as well as technical specifications and supervision, to encourage and support the development of the neurointerventional industry.

The Report details the definition, classification, operational procedures, development history, and favorable industrial policies of neurointerventional technology. For more detailed content, please refer to the full version of the report.

Cerebrovascular disease has currently become the leading cause of health and life-threatening conditions among middle-aged and elderly people in China. From 2017 to 2021, the number of stroke patients in China increased from 4.564 million to 5.173 million, with a compound annual growth rate of 3.2%. It is estimated that by 2026 and 2032, the number of stroke patients in China will grow to about 6.047 million and 7.238 million respectively.

Source: Analysis by Frost & Sullivan

Cerebrovascular diseases can be divided into two main categories based on the cause: hemorrhagic and ischemic. The causes of ischemic stroke are generally intracranial artery stenosis; common causes of hemorrhagic stroke are intracranial aneurysms and cerebral arteriovenous malformations. Among them, intracranial aneurysm is one of the most serious types of hemorrhagic cerebrovascular disease. From 2017 to 2021, the number of people with intracranial aneurysms in China increased from 80.17 million to 84.02 million, with a compound annual growth rate of 1.2%. It is estimated that by 2026 and 2032, the number of people with intracranial aneurysms in China will increase to about 88.2 million and 92.75 million, respectively. After an aneurysm ruptures, the condition is dangerous and develops rapidly, with extremely high mortality and disability rates. Therefore, health management education and early intervention treatment for unruptured intracranial aneurysms are very important.

Source: Analysis by Frost & Sullivan

The Report details the definitions, classifications, disease burden analysis of cerebrovascular diseases and stroke, the clinical manifestations and treatment plans for ischemic and hemorrhagic stroke, as well as the disease burden analysis of intracranial aneurysms. For more detailed content, please refer to the full report.

Neurointerventional devices refer to a collective term for a series of medical consumables used in the diagnosis and treatment of cerebrovascular diseases, centered around neurointerventional procedures. Currently, neurointerventional devices are mainly applied for the diagnosis and treatment of cerebrovascular diseases. According to different functions and indications, neurointerventional devices can be divided into three categories: ischemic, access, and hemorrhagic.

Source: Public information compilation, Frost & Sullivan analysis

Intracranial aneurysm is a typical hemorrhagic cerebrovascular disease, with the incidence ranking third among cerebrovascular diseases. Based on the different stages of aneurysm development, intracranial aneurysms can be divided into unruptured intracranial aneurysms and ruptured intracranial aneurysms. The main treatment options for intracranial aneurysms include open surgery, interventional therapy, and drug therapy.

Before interventional development, open surgery was the main treatment for intracranial aneurysms. However, open surgery is prone to intracranial infection, has many complications, and carries certain risks. The results of the ISAT study have proven that endovascular embolization is more effective than open surgery in treating intracranial aneurysms; the BRAT study also indicates that endovascular coil embolization is superior to open surgery.

Currently, the main methods of endovascular interventional therapy are coil embolization and flow-directed dense network stent (FD) implantation.

Coil embolization is a procedure that uses microcatheter technology to deliver coils into the aneurysm lumen. The coils create vortices when blood flows into the aneurysm, continuously slowing down the flow velocity. Eventually, the flow velocity becomes essentially stagnant, forming a thrombus. As a result, the pressure inside the aneurysm decreases significantly, reducing the likelihood of rupture and avoiding life-threatening situations.

Source: Analysis by Frost & Sullivan

Saccular embolization is suitable for intracranial aneurysms at risk of rupture, with immediate postoperative effects but a high recurrence rate.

Flow-guided dense network stents are designed with a high metal coverage rate and high porosity to reshape local blood flow. They direct the impact flow from the tumor-bearing artery into the aneurysm towards the distal normal blood vessels, thereby reducing the impact of local blood flow on the aneurysm, improving the hemodynamic conditions within the aneurysm, and ultimately forming a thrombus within the aneurysm, leading to its occlusion.

Source: Analysis by Frost & Sullivan

Flow-directed compact mesh stent (FD) implantation is suitable for various aneurysms, especially large or giant ones with wide necks and some complex aneurysms. It has a high complete occlusion rate and significant long-term efficacy, but it cannot completely prevent aneurysm rupture and bleeding.

The Report details the scope of application, treatment indications, involved devices, operating procedures, and clinical research analysis of coil embolization and flow diverter mesh embolization (FD) implantation. For more detailed content, please refer to the full report.

The Report provides a detailed analysis of coil embolization and flow diverter mesh embolization (FD) from the perspectives of technical applicability, application scenarios, advantages and disadvantages, and future development trends. For more detailed content, please refer to the full report.

Currently, there are five types of flow-guided mesh stents listed on the Chinese market. Domestic products include only Shanghai MicroPort's Tubridge and Aikex Medical's LATTICE. Flow-guided mesh stent products from different companies have varying parameter specifications and clinical efficacy.

The Report conducts a comparative analysis of Flow-Directed Dense Network Stents from Medtronic, Stryker, MicroPort Neurosurgery, MECO MicroPre, and Aikang Medical from the perspectives of delivery catheter size, number of braided wires, material of braided wires, metal coverage rate, clinical effectiveness, and safety. It also sorts out the future development trends of Flow-Directed Dense Network Stents. For more detailed content, please refer to the full report.

Currently, the treatment options for ischemic cerebrovascular diseases can be divided into pharmacological and non-pharmacological treatments. Pharmacological treatment mainly includes antiplatelet therapy and anticoagulation therapy. Available antiplatelet drugs include aspirin, clopidogrel, etc., while oral warfarin is recommended for anticoagulation therapy. Non-pharmacological treatments, depending on the patient's condition, may involve endovascular intervention, surgical treatment, etc.

Currently, the treatment options for acute ischemic stroke can be divided into intravenous thrombolysis and antithrombotic therapy, drug therapy, and endovascular intervention. Among these, endovascular intervention can be used for patients who are not suitable for thrombolysis or whose blood vessels have not been effectively opened.

Mechanical thrombectomy is divided into two main categories: stent thrombectomy and direct aspiration thrombectomy. Stent thrombectomy involves approaching the thrombus through a microcatheter, then introducing a stent thrombectomy device into the microcatheter for thrombectomy. Direct aspiration thrombectomy utilizes the principle of negative pressure aspiration, reaching the proximal end of the blood vessel occluded by a thrombus through an aspiration catheter or recanalization catheter to remove the thrombus. Currently, stent thrombectomy is the most conventional method of mechanical thrombectomy.

Stent thrombectomy utilizes microcatheter technology to transport a stent thrombectomy device through an internal arterial pathway in the lower limb to reach the intracranial artery. The thrombectomy device at the front section of the catheter actively 'grabs' and blocks the blood clot in the vessel, restoring vascular patency.

Source: Analysis by Frost & Sullivan

Direct thrombectomy is a rapid, safe, and efficient thrombectomy technique that primarily involves guiding a large-caliber catheter to the surface of the clot and starting strong suctioning. This can reduce the use of medical devices and the time required for vascular recanalization. Direct thrombectomy is performed through an femoral artery approach, where a large inner diameter catheter is pushed proximal to the blocked cerebral artery with the help of a guide wire. An external suction pump is used for automatic suctioning or manual operation with a syringe to create sufficient negative pressure and suction force inside the catheter to remove the thrombus.

Source: Analysis by Frost & Sullivan

Thrombectomy with aspiration and thrombectomy with stenting are not mutually substitutable. The combined effect of both is usually better, and currently, a combination of stenting + aspiration thrombectomy is also used clinically. Multiple different techniques have been developed, including Solumbra, SAVE, SWIM, ADVANCE, and others. Among them, SWIM is currently the most advanced intracranial artery thrombectomy technique, characterized by high efficiency, safety, and speed, greatly improving thrombectomy efficiency. SWIM technology thrombectomy is a comprehensive technique that takes stenting thrombectomy as the cornerstone and combines intermediate catheter contact aspiration to achieve a dual mechanism of 'stent capture' and 'catheter aspiration'.

Source: Analysis by Frost & Sullivan

The Report details the scope of application, treatment range, involved instruments, operating procedures, and clinical research analysis of stent thrombectomy, direct aspiration thrombectomy, and stent + aspiration combination thrombectomy. For more detailed content, please refer to the full report.

The Report provides a detailed analysis of stent thrombectomy, direct aspiration thrombectomy, and combined thrombectomy from the perspectives of the general situation of mechanical thrombectomy treatment plans, applicability, advantages and disadvantages, and future development directions. For more detailed content, please refer to the full report.

Source: NMPA, public data compilation, Frost & Sullivan analysis

Thrombectomy stents have undergone multiple generations of development and are now gradually replacing intravenous thrombolysis. Research shows that the longer the effective thrombectomy length of the stent, the higher the success rate of thrombectomy; the stronger the stent's visualization ability, the better the thrombectomy effect; a dual-layer thrombectomy structure can improve the thrombus capture rate.

The Report analyzes the driving forces for the development of neurointervention in China, future development trends, and the significant importance of intelligent diagnosis and treatment of cerebrovascular diseases. For more detailed content, please refer to the full report.

The Report details the layout of three categories of medical devices in the field of ischemic cerebrovascular diseases by companies such as Minimally Invasive Brain Science, Xinwei Medical, Guichuang Tongqiao, Saino Medical, Peijia Medical, and Aike Medical. It also covers the characteristics of thrombectomy stent products over the years and an analysis of their parameters. For more detailed content, please refer to the full report.

Medtronic was founded in 1949 and went public in 2015. It is headquartered in Dublin, Ireland, and is one of the world's largest medical technology, services, and solutions companies, providing healthcare systems, doctors, clinicians, and patients in more than 150 countries around the globe. Medtronic products cover areas such as cardiovascular care, medical surgery, neuroscience, and diabetes. Among them, products in the cardiovascular field include implantable cardiac pacemakers, aortic valves, and drug-eluting stents; those in the medical surgery field include surgical artificial intelligence and endoscopes; those in the neuroscience field include cranial robot-guided platforms and neuroablation systems; and those in the diabetes field include insulin pumps and continuous glucose monitoring systems.

Stryker was founded in 1946 and went public in 1997. It is headquartered in Michigan, USA and is one of the world's leading medical technology companies. Stryker's products cover areas such as orthopedics, medical and surgical, neurotechnology, and spinal care. Representative products include surgical equipment and navigation systems, endoscopes and communication systems, emergency medical equipment and critical care disposable products, neurosurgery and neurovascular devices, implants for joint replacement and trauma surgery, Mako robotic arm-assisted technology, spinal devices, and other products for various medical specialties.

Meike Micro was established in 1997, with its headquarters located in California, USA. The company has been aiming to improve the treatment of small vessel diseases since its inception. After developing some early concepts and prototypes, the focus shifted to aneurysm treatment. In 2006, the company was acquired by Japan's Terumo Corporation. Currently, the company has launched over 30 products, expanding its therapeutic scope beyond cerebral aneurysms to include ischemic stroke, carotid artery disease, and neurovascular malformations, among others.

Minimally Invasive Brain Science was established in 2012, formerly known as Minimally Invasive Shen Tong. It is one of the earliest medical device platform companies to enter the field of neurointervention in China, located in Zhangjiang Science City, Shanghai. The company focuses on exploring neurointerventional treatment technologies and product research and development, possessing a complete R&D-production-sales pipeline and mastering the key technologies for precise design and manufacturing of neurointerventional devices. Currently, the company has established a comprehensive portfolio of approved therapeutic products, covering three major areas of neurological vascular diseases: hemorrhagic stroke, cerebral atherosclerotic stenosis, and acute ischemic stroke.

Hemu Biotech was established in 2016, and the company has developed a full range of interventional medical devices for peripheral and neurovascular diseases, which are a focus of the company's attention. Hemu Biotech's peripheral interventional medical devices cover both vascular and non-vascular interventions.