Neurovascular Health Screening

Rajesh Uppal March 21, 2023 BioScience, Industry Comments Off on Neurovascular Health Screening 116 Views

A neurovascular disorder is a condition that affects the blood supply in the brain or spinal cord. Neurovascular or cerebrovascular disease refers to all disorders in which an area of the brain is temporarily or permanently affected by bleeding or restricted blood flow.

Restrictions in blood flow may occur from vessel narrowing(stenosis), hardening, or abnormality of the blood vessels; a blockage caused by a clot or embolism; or hemorrhage, or bleeding from a ruptured blood vessel. Blood travels throughout your body via arteries and veins. Arteries are responsible for carrying oxygen-rich blood from the heart to the brain, kidneys, intestines, arms, and legs. Veins carry the blood back to the heart.

Problems that arise along this elaborate network of blood vessels, called the vascular system, can cause severe disability and/or death. While there is no clear cause of neurovascular disease, individuals with diabetes, a history of heart disease, high cholesterol level, and a history of smoking, may be at a greater risk of developing it.

Some neurovascular conditions do not cause symptoms in their early stages, but symptoms may begin to appear as the condition gets worse or changes. Other neurovascular conditions cause sudden, severe symptoms that require emergency treatment and may lead to disability or death. A stroke occurs when blood vessels in the brain are suddenly blocked or burst causing lack of blood and oxygen. Brain cells begin to die causing a wide variety of disabling symptoms and often permanent disability or death.

Symptoms may include sudden weakness on one side of the body, confusion, vision problems, and trouble walking. Assessment of neurovascular status is essential for the early recognition of neurovascular deterioration or compromise. Delays in recognising neurovascular compromise can lead to permanent deficits, loss of a limb and even death. Neurovascular deterioration can occur late after trauma, surgery or cast application.

According to the Southwestern Medical Center, about 795,000 people in the U.S. suffer from a stroke every year. Furthermore, according to the National Center for Biotechnology Information (NCBI), strokes occur more commonly in women than men, especially in elderly population (aged 55 to 65). According to the NHS England, around 1 in 12,500 people in England have ruptured brain aneurysm every year. Furthermore, around 3% of adults in the U.K. have a cerebral aneurysm.

Experts are not sure what causes neurovascular disease, but people who have a personal or family history of heart disease, diabetes, high cholesterol, or smoking may be at greater risk. Increasing prevalence of hypertension, alcohol consumption, and smoking results in brain aneurysm.

Diagnostic tests and procedures are vital tools that help physicians confirm or rule out a neurological disorder or other medical condition. Today, new instruments and techniques allow scientists to assess the living brain and monitor nervous system activity as it occurs. Doctors now have powerful and accurate tools to better diagnose disease and to test how well a particular therapy may be working.

Perhaps the most significant changes during the past 10 years have occurred in genetic testing and diagnostic imaging. Much has been learned from sequencing the human genome (the complete set of a person’s genes) and developing new technologies that detect genetic mutations. Improved imaging techniques provide high-resolution images that allow physicians to view the structure of the brain. Specialized imaging methods can visualize changes in brain activity or the amounts of particular brain chemicals. Scientists continue to improve these methods to provide more detailed diagnostic information.

Neurovascular assessment

A neurovascular assessment is a systematic test used by clinicians to assess neurovascular compromise, impaired blood flow to the extremities, and damage to the peripheral nerves. Assessment of neurovascular status is monitoring the 5 P’s: pain, pallor, pulse, paresthesia, and paralysis.

A neurovascular assessment is required for each affected limb and includes assessment of Pain, Sensation, Motor function, Perfusion (colour, temperature, capillary refill, swelling, pulses)

Pain: The most important indicator of neurovascular compromise is pain disproportionate to the injury. Pain associated with compartment syndrome is generally constant however worse with passive movement to extension and is not relieved with opioid analgesia. Indication of pain in non-verbal patients includes restlessness, grimacing, guarding, tachycardia, hypotension, tachypnoea or diaphoresis. If pain is disproportionate to injury notify medical team

Sensation & Motor function: If neurovascular status is compromised, patients may report decreased sensation, loss of sensation, dysesthesia, numbness, tingling or pins and needles. Altered sensation may be a result of a nerve block or epidural, this should be documented in the patient’s neurovascular assessment in the flowsheet in EMR.

Preventive Health Screenings

Diagnosis

Researchers and physicians use a variety of diagnostic imaging techniques and chemical and metabolic tests to detect, manage, and treat neurological diseases. To diagnose a neurovascular disorder, your doctor will review your medical history, evaluate your symptoms, and perform exams or order tests. Many tests can be performed in a physician’s office or at an outpatient testing facility, with little if any risk to the person. Some procedures are performed in specialized settings to determine particular disorders or abnormalities. Depending on the type of test, results may be immediate or may take time to process.

Physical exam. During your physical exam, your doctor will assess your balance, coordination, and mental alertness. Your doctor will also check for other symptoms, such as numbness, weakness, or paralysis in your legs, arms, or face.
Brain scans include several types of imaging techniques used to diagnose tumors, blood vessel malformations, stroke, injuries, abnormal brain development, and hemorrhage in the brain. Types of brain scans include computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), and single proton emission (SPECT) scans.

Computed tomography (CT) scan. Your doctor may order a CT scan of your brain to determine if there is bleeding, a blockage, or other abnormalities.
Magnetic resonance imaging (MRI). An MRI uses radio waves and magnetic fields to create detailed images of your body. An MRI of your brain may be ordered to determine if there are abnormalities in your brain.
Carotid ultrasound. Carotid ultrasound uses sound waves to create detailed images of your carotid arteries in your neck, which supply blood to your brain. A carotid ultrasound can show plaque buildup or blockage of your carotid arteries. This buildup, called atherosclerosis, is one of the leading causes of stroke.
Cerebral or carotid angiogram. Your doctor will make a small incision leading to one of your arteries, usually in your thigh. Your doctor will then insert a small hollow tube called a catheter into your artery and guide the catheter to the major arteries in your neck. Once in position, your doctor will inject a dye that makes the arteries in your neck and/or brain visible under x-ray imaging to check for signs of hemorrhaging or blockage.
Blood test. Your doctor may order blood tests to determine the time it takes your blood to clot, assess whether you have an infection, and monitor your blood sugar.
Peripheral Arterial Disease (PAD): an Ankle-Brachial Index (ABI) test is performed using blood pressure cuffs on the arms and legs. It is important to screen for PAD because it increases the risk of coronary artery disease, heart attack, or stroke.
Abdominal Aortic Aneurysm (AAA): an ultrasound is performed to screen the abdominal aorta for the presence of an enlargement or aneurysm. AAA can lead to a ruptured aortic artery, which is a serious medical emergency.
Atrial Fibrillation (AFib): an electrocardiogram (ECG) is performed by placing sensors on the arms and legs to screen for irregular heartbeat. AFib can lead to blood clots, stroke, and heart failure, and other heart-related complications.

Genetic testing

Genetic testing of people with a family history of a neurological disease can determine if they are carrying one of the genes known to cause the disorder. Genetic counseling may be recommended for patients, or parents of children being tested, to help them understand the purpose of the tests and what the results could mean. Genetic testing that is used for diagnosis or treatment should be done in a laboratory that has been certified for clinical testing. Clinical testing can look for mutations in specific genes or in certain regions of several genes. This testing may use a panel of genes for a specific type of disease (for example, infant-onset epilepsy) or a test known as whole exome sequencing. Exomes are the parts of the genome formed by exons, which code for proteins. Exome sequencing may take several months to analyze. Clinicians and researchers also sequence whole exomes or whole genomes to discover new genes that cause neurological disorders. Prenatal genetic testing can identify many neurological disorders and genetic abnormalities in utero (while the child is inside the mother’s womb).

Treatment

Your treatment will depend on the type of neurovascular disorder you have. Treatment may include:

Medication. Tissue plasminogen activator (tPA) breaks apart clots and restores blood flow to your brain. Depending on your condition, your healthcare provider may also prescribe anticoagulants (blood thinners), antiplatelet medicine, or other medications to control symptoms.
Intra-arterial thrombolysis. During this procedure, a long, flexible tube, or catheter, is inserted through an artery in your groin to deliver a clot-busting medicine directly to the area where a blood clot is located.
Mechanical clot removal in cerebral ischemia (MERCI). During MERCI, a catheter carrying a small device is threaded through a carotid artery to physically remove a blood clot and restore blood flow.
Carotid endarterectomy. Carotid endarterectomy is a surgical procedure to remove plaque from inside your carotid artery through an incision in your neck.
Carotid angioplasty and stenting. During this procedure, a catheter is threaded through an artery, usually in your groin, and guided to the site of the blockage in your carotid artery. Once in place, your doctor will inflate a balloon to widen your artery and restore blood flow. A small, hollow tube called a stent will then be placed to keep your artery open.
Cerebral artery bypass. Cerebral artery bypass is a surgical procedure that uses a small blood vessel from another part of your body to create a path around a blockage in an artery in your brain.
Stereotactic radiosurgery. Stereotactic radiosurgery delivers a single, high dose of radiation to close off blood vessels. It is often used to treat AVM and cavernous malformation.
Endovascular embolization (coiling). Endovascular coiling plugs or blocks a ruptured aneurysm using small metal coil. micro platinum is placed inside the vessel.
Embolization. Embolization involves the injection of a glue-like material to block abnormal arteries.
Surgical clipping. During this procedure, a clip is placed on an aneurysm ( an abnormal bulge or ballooning in the wall of a blood vessel) to stop blood flow.
Surgical AVM and cavernous malformation removal and repair. This procedure is used to remove AVM or cavernous malformations and fix the deformities in your blood vessels that caused the conditions to develop.
Surgical procedures for moyamoya. Our surgeons use the latest surgical methods to bypass blockages caused by moyamoya disease and promote the development of new blood vessels.

Neurovascular Devices Market

The global neurovascular devices market size was valued at USD 2.68 billion in 2021 and is anticipated to expand at a CAGR of 6.0% in the forecast period. As per DelveInsight estimates, the global Neurovascular Embolization Devices market was valued at USD 1.29 Billion in 2021, growing at a CAGR of 3.50% during the forecast period from 2022 to 2027, to reach USD 1.59 Billion by 2027.

The increasing prevalence of neurological disorders, technological advancements, and increasing demand for minimally invasive procedures are expected to drive the market. The major factors driving the demand for Neurovascular Embolization Devices are the rising cases of haemorrhage stroke, brain aneurysm, and cerebral arteriovenous malformations due to sedentary lifestyles such as excessive consumption of alcohol, serious head injuries, and others. In addition, the rising prevalence of high blood pressure, growing product approval, and increase in the ageing population are also expected to boost the Neurovascular Embolization Devices market. In addition, approval of embolization products would also contribute to Neurovascular Embolization Devices market growth. Furthermore, the ongoing expansion of the geriatric population would also contribute to the Neurovascular Embolization Devices market in the forthcoming years.

Interventional neurology devices are used for the diagnosis and treatment of vascular disease of the brain and central nervous system. Interventional neurology includes endovascular, catheter-based techniques, angiography, and fluoroscopy. Catheter angiography is one of the oldest primaries in-vivo brain vascular imaging modalities used for the diagnosis of several neurological conditions such as cerebral aneurysm, arteriovenous malformations, and intracranial stenosis, arteriovenous fistula, and vasculitis.

There is an increase in incidence of neurological disorders such as brain/ cerebral aneurysm, strokes, and epilepsy among many others in several countries is expected to drive the market growth. The innovative technologies will continue to broaden the range of neuroendovascular tools available for treating a wide range of aneurysm types with greater safety and efficacy. It is fair to say that intracranial aneurysm management is constantly evolving, with sophisticated technology at the forefront of innovation. Thereby, the availability of new treatment options will significantly increase demand for neurovascular devices in the years ahead.

Stroke is the most common cause of death, followed by heart and cancer diseases worldwide. For instance, according to CDC, in 2018, 15.2 million deaths of the 56.9 million deaths worldwide were due to stroke. Acute Ischemic Stroke (AIS) is the most common form of stroke, caused due to reduced blood supply to the brain, making brain cells to die. For instance, according to the U.S. CDC, 87.0% of strokes are classified as ischemic strokes, with the U.S. being the most affected country.

Therefore, such high prevalence of acute ischemic stroke is anticipated to boost the market growth over the forecast period.

According to the Brain Aneurysm Foundation, an estimated 6 million Americans are affected by cerebral aneurysms each year. Every year, the disease kills half a million people globally. Approximately 40% of ruptures result in death, and approximately 66% of those who survive have some permanent brain damage. Thus, the vast and rapidly growing patient population base for target diseases across the key markets is primarily responsible for the significant volume consumption of neurovascular devices, leading to market growth.

However, certain complications associated with the neurovascular embolization procedures, such as procedural aneurysmal perforations by the microcatheter, micro-guidewire, or coil, among others, are likely to impede the Neurovascular Embolization Devices market.

Device Insights

Based on device, neurovascular device market is segmented into cerebral angioplasty and stenting systems, cerebral embolization and aneurysm coiling devices, and support devices. Cerebral embolization and aneurysm coiling devices is further segmented into, flow diversion devices, embolic coils, and liquid embolic agents. Cerebral angioplasty and stenting systems are further segmented into embolic protection systems and carotid artery stents. Neurothrombectomy devices are further classified into clot retrieval devices, suction devices, and vascular snares.

In 2021, cerebral embolization and aneurysm coiling devices dominated the neurovascular device market with the share of 37.69%. Increasing prevalence of neurological conditions such as brain aneurysm, stroke, arteriovenous malformations (AVMs), rising healthcare expenditure, and increasing R&D investment are few factors contributing towards the market growth.

Neurothrombectomy devices segment is expected to grow at the highest CAGR of 7.0% during the forecast period owing to the rising prevalence of acute ischemic stroke and increasing number of product launches by the key market players. For instance, in 2019, Medtronic announced the launch of Solitaire X revascularization device used for the removal of blood clot in the brain. Furthermore, the use of clot retrievers has increased in elderly patients (aged 55 to 65) due to growing incidence of stroke.

Therapeutic Application Insights

In 2021, stroke segment dominated the market with the highest CAGR of 6.2% owing to the factors such as increasing prevalence of stroke, hypertension, and other neurological disorders. According to the CDC, 1 in 6 people worldwide will have a stroke in their lifetime and every year, more than 795,000 people in the United States have a stroke. Strokes are the second leading cause of death globally, and account for an approximate 140,000 deaths in the United States annually.

Increasing government and NGOs awareness initiatives worldwide, is further adding to the segment growth. For instance, in 2018, the Stroke Alliance for Europe (SAFE) with member from 12 countries, a non-profit organization joined Boehringer’s Ineglheim’s (BI) Angel’s Initiative for providing the critical information to the stroke patients. Advent of technologically advanced products are also powering the growth of the market.

The cerebral aneurysm segment is expected to grow at the highest CAGR of 6.6% during the forecast period, primarily owing to the rising incidence of intracranial aneurysm. According to the Brain Aneurysm Foundation, an approximate 6.5 million people in US have an unruptured brain aneurysm and about 30,000 people suffer a brain aneurysm rupture each year. Further, increasing demand for minimally invasive surgical procedures, introduction of technologically advanced products and In February 2020, Cerus Endovascular Ltd. received European CE Mark approval for its lead product, the Contour Neurovascular System, for the treatment of intracranial aneurysms.

Geographical insights

North America dominated the market with the share of 26.65% in 2021 owing to the presence of key manufacturers such as Stryker Corporation, Penumbra, Inc., Johnson & Johnson, and Merit medical systems, Inc. in the region. In April 2020, Cerus Endovascular Ltd. received CE Mark approval for its 0.021-inch Contour Neurovascular System, compatible with smaller commercially available 021 microcatheters for treatment of saccular intracranial aneurysms.

Increase in the R&D investment by the manufacturers and rise in the government initiatives are contributing immensely to the regional market growth. For instance, Medtronic Neurovascular Clinical Affairs is sponsoring a clinical trial to assess the safety and effectiveness of the ‘Pipeline Vantage Embolization Device’ with Shield Technology in the treatment of intracranial aneurysms within the intended indication for use. Also, recently in April 2021, the Society of Neurointerventional Surgery (SNIS) and NeuroPoint Alliance (NPA) collaborated with the Society of Vascular and Interventional Neurology (SVIN) to the NeuroVascular Quality Initiative-Quality Outcomes Database (NVQI-QOD).

Asia Pacific is expected to grow at the highest CAGR of 7.9% during the forecast period due to the factors such as rising target disease burden. According to an article published by M Gourie Devi, it is projected that around 30 million people in India suffer from several forms of neurological diseases and the average prevalence rate is 2,394 patients per 1,00,000 of the population. Furthermore, factors such as rising healthcare expenditure, entry of key players in the region are also contributing towards the market growth.

Industry

Key Neurovascular Embolization Devices companies proactively working in the market include Codman Neuro (Integra Lifesciences), Medtronic, Stryker, MicroVention, Inc. (Terumo Corporation), Johnson & Johnson Services, Inc., Penumbra, Inc., Balt, B. Braun Melsungen AG, Acandis GmbH, Wallaby Medical., Shape Memory Medical Inc., Zylox-Tonbridge Medical Technology Co., Ltd., Spartan Micro, Inc., KANEKA CORPORATION, Lepu Medical Technology(Beijing)Co., Ltd., Meril Life Sciences Pvt. Ltd., Boston Scientific Corporation, phenox GmbH, Merit Medical Systems., Perflow Medical Ltd., Medtronic; MicroPort Scientific Corporation., Microvention Inc (Terumo Corporation); Cerus Endovascular, Rapid Medical, among others.

Industry Developments

In April 2019, Medtronic announced the launch of its fourth-generation Solitaire X revascularization device, which is designed for the treatment of AIS. Furthermore, In May 2019, Vesalio received CE mark approval for NeVa—an advanced neurothrombectomy device, featuring an optimized delivery system for efficient results. These devices expand on Drop Zone and Smart Maker technologies, introducing features such as distal filter.

In August 2020, an Israel based company, Rapid Medical, has been granted European regulatory clearance to launch and commercialize its ‘TIGERTRIEVER XL device for removing large ischemic stroke-causing clots from intracranial vessels. Thus, the introduction of technologically advanced products and rapid product approval process are factors expected to fuel market growth.

In February 2020, NeuroVasc Technologies, Inc. entered a strategic partnership with the Wego Group that includes USD 34 million in funding to support the firm’s product portfolio development and global clinical trial program. The strategic alliance marks a major step forward for NeuroVasc Technologies in bringing a full neurovascular platform to market.

In December 2020, Terumo Corporation launched the WEB Embolization System (Product name in Japan: Woven EndoBridge Device), an intrasaccular aneurysm treatment device. The device is a first-of-its-kind intrasaccular flow disruptor device available for the Japanese market. With the commercial launch, Terumo aims to provide new treatment options for brain aneurysm cases that were challenging to treat in currently approved approaches.

In August 2020, Stryker Corporation launched the Surpass Evolve Flow Diverter following approval from the U.S. FDA. It is the first 64-wire cobalt-chromium flow diverter in the United States, and it is intended to aid aneurysms heal. Surpass Evolve is Stryker’s newest flow diversion innovation, following the release of Surpass Streamline in late 2018.

In October 2020, Shanghai MicroPort NeuroTech Co., Ltd. (“MicroPort® NeuroTech”) received the registration certificates issued by China’s National Medical Products Administration (NMPA) for its proprietary NUMEN Coil Embolization System and NUMEN FR Coil Detachment System for the treatment of cerebral aneurysms through minimally invasive neurovascular intervention.

In July 2021, Zylox-Tonbridge Medical Technology Co., Ltd., a neuro- and peripheral-vascular interventional medical device company, raised USD 329 million to support the development and commercialization of its core products which include Neurovascular Embolization coils, a microcatheter for coiling, among others.