The European neurovascular device market is a continuously growing industry, led by a forecasted increase of strokes and brain aneurysms.
Over the past several years, there has been a transition in interventional neuroradiology from surgical to endovascular techniques. This has caused a conversion from aneurysm clipping to endovascular coiling, and more recently, to flow diverting and intrasaccular stents. For many years, the gold standard treatment for strokes has been the administration of clot dissolving or clot busting medication, called tissue plasminogen activator (tPA). New technologies, such as stent retrievers and aspiration catheters, offer longer time windows for treatment after symptom onset and, when used in conjunction with tPA, can improve clinical outcomes.
This shifting of stroke and brain aneurysm treatment has resulted in notable market growth in the respective markets, which are forecasted to grow further as more novel and technologically advanced devices gain further adoption in the medical community.
Strokes
There will be steady, moderate market growth in the neurovascular thrombectomy market over the forecast period, driven by growth in unit sales as thrombectomy devices are adopted as the standard of care for acute ischemic stroke patients.
An ischemic stroke requires immediate treatment. The main goal of the treatment is to reduce brain injury by restoring blood flow and removing the blockage very quickly. Treatment options include tissue plasminogen activator (tPA) drugs and a mechanical thrombectomy procedure.
The thrombectomy market includes stent retrievers and aspiration catheters. The majority of the time, a combination of the two categories is used, but there a number of factors that can impact treatment decisions, such as physician preference, anatomy, and clot locations. Studies have found that new stent retriever devices have comparable efficacy to the latest generation of aspiration catheters. Additional clinical trials will influence whether the devices continue to be used in conjunction or whether one category will cannibalize shares from the other.
Compared to other neurovascular markets, the thrombectomy market varies significantly in device usage and year-over-year growth, from country to country. For example, the German market was approximately seven times larger than the U.K. market in 2022, with Spain, France, and Italy being somewhere in the middle. Numerous countries are not adequately addressing their need for thrombectomy treatments. For example, a 2019 report published by the British Association of Stroke Physicians (BASP) stated that there is a “worrying” lack of stroke specialists and to meet patient demands, the number needs to increase by at least a third. The large addressable population, which is similar in other European countries, will drive market growth as procedural growth occurs.
COVID-19 related impact also varies from country to country within the thrombectomy market. Overall, the total European market experienced only a moderate decline in 2020, fully recovering in 2022.
Brain Aneurysms
A brain aneurysm is a localized dilation of the blood vessel in a cerebral artery or vein. An aneurysm is a weakened area in the wall of an artery in the brain. This area bulges in the artery and if it ruptures it can lead to a bleed in the brain and cause stroke, brain damage and even death. A brain aneurysm usually has no symptoms or signs.
Interventional neuroradiologists will typically perform the detachable coil embolization process to alleviate dangers associated with aneurysms. An unruptured aneurysm may be detected only during tests, such as imaging with angiography. Emergency treatment for ruptured aneurysms involves restoring normal blood circulation in the brain and reducing intracranial pressure. Treatment options include surgical clipping and endovascular coiling. Flow diverting and intrasaccular stents offer another treatment alterative for large aneurysms.
Aneurysm Clips
A neurosurgical clipping procedure involves a specially designed clip and is usually carried out by craniotomy to approach the aneurysm and close it. In most cases the aneurysm itself is clipped; some complicated cases may require the artery itself to be clipped.
The market for aneurysms clips is projected to decline slightly over the forecast period. As European countries continue to adopt endovascular coiling procedures, the use of aneurysm clips will decline in this saturated market. However, aneurysm clips cannot be completely replaced by coiling, since clips have been shown to lead to lower recurrence rates and can have greater efficacy for certain conditions.
The aneurysm clip market was not as severely impacted by the COVID-19 pandemic as other neurovascular markets. One of the dangers of COVID-19 is that it increases the likelihood of a rupture of arteriovenous malformations (AVMs), which are treated with temporary clips.
In the U.S. and European markets, manufacturers of second and third-generation aneurysm clips are replacing chromium cobalt clips with titanium because of the material’s superior safety and compatibility with magnetic resonance imaging (MRI). However, titanium clips command a higher ASP than other alloy clips.
Detachable Coils
Endovascular coiling or coil embolization procedures involve inserting coils endovascularly to block blood flow and fill aneurysms. A small incision is made near the patient’s groin to insert the catheter, which is then manipulated through the circulatory system to the aneurysm. Coils are inserted through the catheter to fill the aneurysm and the body will respond by forming a blood clot around the coil, thereby strengthening its position. Coils must strike a balance between softness and stiffness so that the coil avoids disruption of the aneurysmal wall, but does not migrate out of the aneurysm.
The decrease in market value for coils will therefore be driven by both fewer unit sales and price decreases, with a shift away from the use of coated coils. A 2019 study suggests fiber coils convincingly demonstrated a huge difference in terms of acute occlusion compared to non-fibered coils, but it may take several years before this speculative technology becomes indicated for neurology applications and adopted by the coil market.
Unit sales of coils will be threatened by new technologies, such as flow diverter or intrasaccular devices, that will cannibalize aneurysm treatment procedures. As more aneurysms are treated by new technology, and those remaining use fewer coils, there will be a decrease in unit sales.
Flow Diverting and Intrasaccular Stents
A rapidly growing alternative for treating large aneurysms is the use of flow diverting and intrasaccular stents. These devices work by restoring the original, natural blood circulation in the artery, allowing the stagnant blood within the lesion to coagulate and providing permanent long-term occlusion. These innovative devices look to take market share from aneurysm clips, detachable coils and traditional stents.
Flow diversion stents have experienced rapid growth in Europe in the past 15 years and are now used to treat the majority of large aneurysm cases that meet the device’s indications. As technology improves there may be opportunity for these devices to cannibalize more market share of competing devices if they become indicated for smaller aneurysms. However, these devices will experience cannibalization themselves when new products in the pipeline become approved for aneurysm treatments, such as intrasaccular stents.
There are currently two brands of intrasaccular stent offered in the European market; MicroVention’s WEB™ device and Cerus Endovascular’s Contour Neurovascular System. These technologies have just begun to become legitimate contenders in the aneurysm embolization market, so there is potential for massive market growth, depending on international adoption rates and shifts in reimbursement policies. One WEB™ device can cost five times as much as a set of embolization coils, where countries are reluctant to reimburse hospitals more than the cost of the established embolization techniques. This situation has resulted in a declining ASP for the device as it becomes increasingly popular in many countries, such as Germany, France and the U.K. Despite this ASP decline, with unit sales increasing rapidly year-over-year, the intrasaccular stent market is expected to surge with significant growth in 2022.
Closing Thoughts
The total neurological device market is expected to grow more than 40% by the end of the forecast period, with a mid-single-digit CAGR. This increase will be fueled by aging demographics, neurological procedural growth and extensive technological advancements, especially in the stroke treatment markets.
While this article focuses on the neurovascular device market, iData Research’s European Neurological Devices Report includes in-depth market analysis on neuromodulation devices, CSF management, ultrasonic aspirators and more.
About the Authors
John Fraser is an analyst team leader at iData Research. He develops and composes syndicated and custom research projects regarding the medical device industry, publishing the European Neurological Device Market research report.
Kamran Zamanian, Ph.D., is CEO and founding partner of iData Research. He has spent over 20 years working in the market research industry with a dedication to the study of medical devices used in the health of patients all over the globe.
About iData Research
For 19 years, iData Research has been a strong advocate for data-driven decision-making within the global medical device, dental and pharmaceutical industries. By providing custom research and consulting solutions, iData empowers its clients to trust the source of data and make important strategic decisions with confidence.
