Cerebral Protection System Market Size
Cerebral Protection System Market Analysis
The Cerebral Protection System Market size is estimated at USD 1.29 billion in 2025, and is expected to reach USD 1.71 billion by 2030, at a CAGR of 8.51% during the forecast period (2025-2030).
The high prevalence of cardiovascular diseases and the adoption of advanced surgical techniques are the factors driving the market's growth over the forecast period.
The significant prevalence of cardiovascular diseases, including aortic stenosis, has led to more procedures like transcatheter aortic valve replacement (TAVR). To reduce the chance of stroke caused by cerebral embolism during these procedures, the need for cerebral protection systems has grown significantly. For instance, an article published in the American Heart Association Journals in June 2023 mentioned that peripheral artery disease affected an estimated 200 million people worldwide, including 7 to 12 million individuals in the United States in 2023. Additionally, a study published in the Lancet Global Health in October 2023 highlighted that peripheral artery disease was more common in older individuals, with a prevalence of 14.91% in those aged 80-84 years in 2023. Furthermore, prevalence was generally higher in females than in males. Thus, the significant prevalence of peripheral disorders leads to the rising demand for cerebral protection systems during surgical procedures, as they are used to protect the cerebral system and to reduce ischemic injury to the brain during surgical procedures, thereby contributing to the growth of the market.
Further, the increasing adoption of cerebral protection systems in cardiovascular surgical procedures is expected to contribute to the growth of the market. For instance, an article published in the Journal of Cardiology and Therapy in February 2024, mentioned that the use of the Sentinel cerebral protection system (CPS) device during transcatheter aortic valve implantation (TAVI) was associated with a lower incidence of periprocedural disabling strokes compared to cases without transcatheter cerebral embolic protection (TCEP) devices. Additionally, an article published in the Journal of Structural Heart in September 2024, highlighted that patients with atrial fibrillation undergoing transcatheter aortic valve replacement (TAVR) with cerebral embolic protection device (CPD) experience a lower incidence of overall stroke and major stroke. The Sentinel cerebral embolic protection device (CPD) functions by capturing and removing debris, which reduces the risk of stroke. Due to such advantages of cerebral protection system, the adoption of these devices is expected to rise, thus contributing to the growth of the market.
Thus, the high prevalence of cardiovascular and peripheral diseases, and the growing adoption of cerebral protection systems are expected to contribute to the growth of the market over the forecast period.
Cerebral Protection System Market Trends
Clarets Sentinal System is Expected to Hold a Significant Share in the Market Over the Forecast Period
Clarets sentinel systems are indicated for use as an embolic protection device to capture and remove thrombus/debris while performing cardiovascular procedures. Thus, they are widely preferred in these procedures. Rising cardiovascular diseases and a high volume of cardiac surgeries are the factors responsible for the growth of the studied segment.
The significant adoption of sentinel cerebral protection systems is anticipated to drive the segment growth. For instance, an article published in JAMA Cardiology in October 2024, highlighted that in the PROTECTED TAVR trial, patients in the United States, Europe, and Australia were randomized to undergo transcatheter aortic valve replacement (TAVR) either with or without the Sentinel cerebral embolic protection (CEP) device. The trial aimed to assess the safety and efficacy of the device. While the primary endpoint - a reduction in overall strokes within 72 hours or at discharge with CEP use—was not achieved, a notable 62% relative reduction in disabling strokes was observed in a smaller subset (20 vs. 8 patients). This outcome highlights the potential of the Sentinel cerebral protection system to address critical needs in stroke prevention during TAVR procedures, which could drive growth in this segment as healthcare providers increasingly prioritize patient safety and outcomes.
The increasing clinical trials associated with sentinel cerebral protection system is anticipated to fuel the segment growth. For instance, in March 2024, Protembis, a German-based company, secured USD 30 million in Series B funding to launch a pivotal clinical trial for its intra-aortic filter device. The trial, a multi-center, randomized study, will evaluate the safety and effectiveness of the ProtEmbo Cerebral Embolic Protection device in 500 patients undergoing transcatheter aortic valve replacement (TAVR). Patients will be randomized to either receive the Boston Scientific Sentinel cerebral embolic protection (CEP) device or will not receive CEP. The inclusion of Boston Scientific's Sentinel CEP device in this trial highlights its established presence in the cerebral protection system market. The results of this study could further solidify the Sentinel system's position and potentially drive growth in this segment, as it continues to be a benchmark for comparison in clinical evaluations.
In conclusion, the Sentinel cerebral protection system segment is expected to witness significant growth due to its demonstrated potential in reducing disabling strokes during TAVR procedures and its established role as a benchmark in clinical trials.
North America is Expected to Hold a Significant Market Share Over the Forecast Period
North America is expected to hold a major share of the market owing to the rising incidence of cardiovascular and peripheral diseases and the growing geriatric population. The presence of key market players and the rising adoption of technological advancements are also expected to drive the market's growth.
The significant number of individuals affceted with cardiovascular diseases in the region is expected to drive the demands for cerebral protection systems used during cardiac surgical procedures, hence contributing to the market growth. For instance, the data published by the Canadian Heart Failure Society in May 2024 mentioned that over 100,000 Canadians receive a diagnosis of heart failure annually, and approximately 800,000 Canadians were living with the condition in 2023. Additionally, according to the October 2024 update of the United States Centers for Disease Control and Prevention (CDC), about 805 thousand people in the United States have a heart attack every year. Such a prevalence of cardiovascular diseases in this region is also expected to drive the market's growth.
Additionally, the high volume of cardiac surgeries in North American countries is expected to drive the growth of the market. For instance, an article published by Mass General Brigham Incorporated in November 2024, mentioned that over 900 thousand cardiac surgeries, including coronary bypass procedures, are conducted annually in the United States. Such a high volume of cardiac surgeries is expected to contribute to the growing demand for cerebral protection systems as these systems reduce cerebrovascular risks, thereby contributing to the growth of the market in this region over the forecast period.
The significant number of cardiac centres in the region is anticipated to drive the demand for cerebral protection system used during cardiac durgical procedures, boosting the market growth. For instance, an article published in Canadian Journal of Cardiology in June 2024, highlighted that Canada has 32 cardiac centers where adult cardiac surgeons practice, resulting in 0.79 centers per million people, a rate slightly higher than the global average of 0.73 per million. Thus, the region's strong healthcare infrastructure and increasing adoption of innovative medical devices, are expected to sustain the market's growth trajectory over the forecast period.
Thus, the increasing incidence of cardiovascular diseases, high cardiac surgical volume and strong healthcare infrastructure is expected to contribute to the growth of the market over the forecast period in North America.
Cerebral Protection System Industry Overview
The cerebral protection systems market is moderately consolidated due to the presence of few market players. The competitive landscape analysis examines key international and local companies with significant market share and brand recognition. The key players include Abbott Laboratories, Boston Scientific Corporation, Medtronic Plc, Venus Medtech (Keystone Heart), and Edward Lifesciences Corporation , among others.
Cerebral Protection System Market Leaders
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Abbott Laboratories
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Boston Scientific Corporation
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Edward Lifesciences Corporation
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Venus Medtech (Keystone Heart)
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Medtronic Plc
- *Disclaimer: Major Players sorted in no particular order
Cerebral Protection System Market News
- November 2024: EmStop, Inc. introduced the successful completion of the CAPTURE-1 early feasibility clinical trial, which supports the company’s integrated embolic protection system (EPS) intended for transcatheter aortic valve replacement (TAVR). The EmStop device aims to ensure complete cerebral protection during left heart catheterization procedures.
- July 2024: The European Investment Bank (EIB) provided EUR 20 million in venture-debt financing to the German medical technology company Protembis to advance a next-generation device aimed at safeguarding the brains of patients receiving specific heart treatments. This funding will facilitate clinical trials, research, development, and market entry for its “ProtEmbo” cerebral embolic protection system.
Cerebral Protection System Industry Segmentation
As per the scope of the report, cerebral protection devices are used to provide a mechanical barrier against the debris that causes embolization in the cerebral anterior circulation during cardiovascular procedures. These systems have reduced the risk of cerebrovascular incidents related to cardiac procedures. The cerebral protection system market is segmented by type, application, end-user and geography. By type, the market is segmented into clarets sentinel system, keystone hearts trigaurd device, and embrella embolic deflector. By application, the market is segmented into carotid artery stenting (CAS), transcatheter aortic valve replacement (TAVR/TAVI), neurovascular procedures and other cardiovascular surgeries. Other cardiovascular surgeries include coronary artery bypass grafting (CABG) with aortic manipulation and aortic aneurysm repair, among others. By end-user, the market is segmented into Hospitals, Ambulatory Surgical Centers (ASCs) and Specialty Clinics. By geography, the market is segmented into North America, Europe, Asia-Pacific, and Rest of the World. For each segment, the market size is provided in terms of USD value.
By Type | Clarets Sentinel System | ||
Keystone Hearts Trigaurd Device | |||
Embrella Embolic Deflector | |||
By Application | Carotid Artery Stenting (CAS) | ||
Transcatheter Aortic Valve Replacement (TAVR/TAVI) | |||
Neurovascular Procedures | |||
Other Cardiovascular Surgeries | |||
By End-User | Hospitals | ||
Ambulatory Surgical Centers (ASCs) | |||
Specialty Clinics | |||
Geography | North America | United States | |
Canada | |||
Mexico | |||
Europe | Germany | ||
United Kingdom | |||
France | |||
Italy | |||
Spain | |||
Rest of Europe | |||
Asia-Pacific | China | ||
Japan | |||
India | |||
Australia | |||
South Korea | |||
Rest of Asia-Pacific | |||
Rest of the World |
Clarets Sentinel System |
Keystone Hearts Trigaurd Device |
Embrella Embolic Deflector |
Carotid Artery Stenting (CAS) |
Transcatheter Aortic Valve Replacement (TAVR/TAVI) |
Neurovascular Procedures |
Other Cardiovascular Surgeries |
Hospitals |
Ambulatory Surgical Centers (ASCs) |
Specialty Clinics |
North America | United States |
Canada | |
Mexico | |
Europe | Germany |
United Kingdom | |
France | |
Italy | |
Spain | |
Rest of Europe | |
Asia-Pacific | China |
Japan | |
India | |
Australia | |
South Korea | |
Rest of Asia-Pacific | |
Rest of the World |
Cerebral Protection System Market Research FAQs
How big is the Cerebral Protection System Market?
The Cerebral Protection System Market size is expected to reach USD 1.29 billion in 2025 and grow at a CAGR of 8.51% to reach USD 1.71 billion by 2030.
What is the current Cerebral Protection System Market size?
In 2025, the Cerebral Protection System Market size is expected to reach USD 1.29 billion.
Who are the key players in Cerebral Protection System Market?
Abbott Laboratories, Boston Scientific Corporation, Edward Lifesciences Corporation, Venus Medtech (Keystone Heart) and Medtronic Plc are the major companies operating in the Cerebral Protection System Market.
Which is the fastest growing region in Cerebral Protection System Market?
Asia-Pacific is estimated to grow at the highest CAGR over the forecast period (2025-2030).
Which region has the biggest share in Cerebral Protection System Market?
In 2025, the North America accounts for the largest market share in Cerebral Protection System Market.
What years does this Cerebral Protection System Market cover, and what was the market size in 2024?
In 2024, the Cerebral Protection System Market size was estimated at USD 1.18 billion. The report covers the Cerebral Protection System Market historical market size for years: 2019, 2020, 2021, 2022, 2023 and 2024. The report also forecasts the Cerebral Protection System Market size for years: 2025, 2026, 2027, 2028, 2029 and 2030.
Cerebral Protection System Industry Report
Statistics for the 2025 Cerebral Protection System market share, size and revenue growth rate, created by Mordor Intelligence™ Industry Reports. Cerebral Protection System analysis includes a market forecast outlook for 2025 to 2030 and historical overview. Get a sample of this industry analysis as a free report PDF download.