Transcatheter aortic valve replacement (TAVR) embolic protection devices are specialized medical devices used during TAVR procedures. TAVR is a minimally invasive surgical technique designed to treat aortic valve stenosis, a condition in which the aortic valve in the heart becomes narrowed and obstructs blood flow. During TAVR, a new artificial valve is typically inserted into the heart through a catheter, avoiding the need for open-heart surgery.
Embolic protection devices used in TAVR procedures are specifically designed to capture and prevent the release of embolic debris (small particles or clots) that may break loose during the procedure. These embolic debris can potentially travel through the bloodstream and cause blockages or damage to other organs, including the brain, which can lead to complications such as stroke or organ damage.
The primary function of TAVR embolic protection devices is to reduce the risk of embolic events by capturing and containing any debris that might dislodge during the valve replacement procedure. These devices often consist of filters or mesh-like structures that are inserted into blood vessels to catch and trap any embolic material before it can cause harm. The growth of the TAVR embolic protection market is primarily driven by rise in incidence of cardiovascular diseases, particularly aortic valve stenosis, and the expanding geriatric population.
For instance, according to an article published in the National Library of Medicine, in 2021, aortic valve stenosis (AVS) is a common heart valve condition that becomes more prevalent with age, affecting approximately 13.2% of patients aged 75 and older. This condition is characterized by the scarring and accumulation of calcium in the valve cusp.
The growing prevalence of aortic valve stenosis in the elderly population, who often choose minimally invasive procedures such as TAVR, is a key factor driving the demand for cerebral embolic protection devices. These devices are essential for minimizing complications associated with the dislodgment of embolic debris during TAVR procedures. Thus, rise in preference for TAVR as a treatment option for aortic valve stenosis among elderly patients, who are more susceptible to cardiovascular diseases, fuels the demand for cerebral embolic protection devices and thereby drives the market growth.
However, factors that hamper the market growth include procedural complexities and high costs TAVR embolic protection devices. Utilization of these devices often requires specialized training for healthcare professionals, contributing to the challenge of implementation. In addition, the high cost associated with cerebral embolic protection devices can be a significant deterrent, particularly in regions with limited healthcare budgets.
Thus, the combination of these factors can hinder widespread adoption and market growth, necessitating efforts to simplify procedures and reduce costs to make these devices more accessible to healthcare providers and patients. Furthermore, the market is poised for potential growth, owing to a rise in initiatives undertaken by government organizations and key industry players in the development of advanced devices. These collaborative efforts aim to enhance the safety and effectiveness of cerebral embolic protection devices, which can lead to better patient outcomes.
In addition, ongoing clinical trials focused on improving these devices are expected to yield promising results. These developments are anticipated to create lucrative opportunities for the market expansion during the forecast period, as they can lead to the introduction of more innovative and efficient cerebral embolic protection solutions, meeting the evolving needs of healthcare providers and patients.
The TAVR embolic protection market is segmented into product type and region. By product type, the market is categorized into SENTINEL cerebral protection system and TriGUARD 3 CEP device technology. Region-wise, the market is analyzed across North America (the U.S. and Canada), Europe (Germany, France, the UK, Italy, and rest of Europe), Asia-Pacific (Japan, China, Australia, India and rest of Asia-Pacific), and LAMEA (Latin America and Middle East & Africa).
The key players operating in the TAVR embolic protection market are Boston Scientific Corporation, Edward Lifesciences Corporation, Filterlex Medical Ltd., Innovative Cardiovascular Solutions, LLC., Protembis GmbH, Transverse Medical Inc., Emboline, Inc., Cardioptimus ,EnCompass Technologies, Inc., and Venus MedTech HangZhou Inc. The key players have adopted strategies such as product approval, funding and clinical trials to enhance their product portfolio.
Key Benefits For Stakeholders
- This report provides a quantitative analysis of the market segments, current trends, estimations, and dynamics of the tavr embolic protection market analysis from 2022 to 2032 to identify the prevailing tavr embolic protection market opportunities.
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- Porter's five forces analysis highlights the potency of buyers and suppliers to enable stakeholders make profit-oriented business decisions and strengthen their supplier-buyer network.
- In-depth analysis of the tavr embolic protection market segmentation assists to determine the prevailing market opportunities.
- Major countries in each region are mapped according to their revenue contribution to the global market.
- Market player positioning facilitates benchmarking and provides a clear understanding of the present position of the market players.
- The report includes the analysis of the regional as well as global tavr embolic protection market trends, key players, market segments, application areas, and market growth strategies.
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Key Market Segments
By Product
- SENTINEL cerebral protection system
- TriGUARD 3 CEP device technology
By Region
- North America
- U.S.
- Canada
- Europe
- Germany
- France
- UK
- Italy
- Rest of Europe
- Asia-Pacific
- Japan
- China
- India
- Australia
- Rest of Asia-Pacific
- LAMEA
- Latin America
- Middle East And Africa
- Key Market Players
- Protembis GmbH
- Innovative Cardiovascular Solutions, LLC.
- Filterlex Medical Ltd.
- Cardioptimus
- Transverse Medical Inc.
- Venus MedTech HangZhou Inc.
- EnCompass Technologies, Inc.
- Boston Scientific Corporation
- Edward Lifesciences Corporation
- Emboline, Inc.
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Table of Contents
Executive Summary
According to the report, the tavr embolic protection market was valued at $108.8 million in 2022, and is estimated to reach $405.4 million by 2032, growing at a CAGR of 14% from 2023 to 2032.The TAVR embolic protection market is likely to experience a significant growth rate of 14% from 2023-2032 owing to increasing market demand of SENTINEL Cerebral Protection System segment.
Transcatheter Aortic Valve Replacement (TAVR) embolic protection devices are specialized medical tools designed to safeguard patients undergoing TAVR procedures from the risk of embolic complications. During TAVR, a prosthetic aortic valve is implanted through a catheter, which can dislodge debris and small particles that may enter the bloodstream, potentially causing strokes or other adverse events. Embolic protection devices act as filters or shields, intercepting and capturing these particles, preventing their passage to vital organs such as the brain. These devices enhance the safety and efficacy of TAVR, minimizing the risk of embolic events and contributing to better patient outcomes in the treatment of aortic valve stenosis.
The aging population is exerting a significant influence on the growth of the embolic protection device market. As the global demographic landscape shifts towards an increasingly elderly population, the prevalence of cardiovascular diseases, including aortic stenosis, is on the rise. This demographic segment is more susceptible to such health conditions, necessitating interventions like Transcatheter Aortic Valve Replacement (TAVR), where embolic protection devices play a crucial role. The surge in elderly patients opting for minimally invasive procedures like TAVR to address their cardiovascular issues amplifies the demand for these devices, making the aging population a driving force behind the sustained growth of the embolic protection device market.
Furthermore, technological advancements are playing a pivotal role in propelling market growth. Continuous innovation has led to the development of more sophisticated and efficient embolic protection devices. These devices now offer improved filter designs, materials, deployment techniques, and enhanced navigability within the cardiovascular system, making them increasingly attractive to healthcare providers and patients alike. For instance, EnCompass Technologies, Inc., a privately held medical device company, has developed F2 filter, which has the smallest average pore size among all CEP devices at 30 µm. Moreover, During the TAVR procedure, 360-degree wall apposition of the F2 filter in the aortic arch is designed to prevent migration.
In addition, cardiologists and healthcare professionals are increasingly recognizing the value of cerebral embolic protection devices. As awareness of the potential risks of embolic events during TAVR procedures grows, cardiologists are more inclined to incorporate these devices into their practice. This adoption trend is bolstered by clinical evidence showcasing their effectiveness in reducing the risk of stroke and other complications during TAVR interventions. For instance, the research published in the new England journal of medicine, in 2022, demonstrated that out of 3000 randomized patients, 1501 were assigned to the CEP (cerebral embolic protection) group and 1499 to the control group, where it was recorded that incidence of stroke within 72 hours after TAVR or before discharge was 2.3% in CEP group and 2.9 % in control group. This study's findings highlight the impact on incidence of periprocedural stroke. Thereby driving the demand for cerebral embolic protection device adoption.
Furthermore, the rise in regulatory approvals is further contributing to the market growth. For instance, in March 2020, Keystone Heart Ltd., a Venus Medtech Company, received European CE Mark for the TriGUARD 3 Cerebral Embolic Protection (CEP) Device. The device is designed to minimize the risk of cerebral damage by deflecting embolic debris away from cerebral circulation during Transcatheter Aortic Valve Implantation (TAVI) and other transcatheter heart procedures. Such approvals not only enhance patient safety but also instill confidence among healthcare providers, thereby driving the adoption and market growth of these critical medical devices.
The global TAVR embolic protection market is segmented into product type and region. By product type, the market is categorized into SENTINEL Cerebral Protection System and TriGUARD 3 CEP Device Technology. Region-wise, the market is analyzed across North America (the U.S. and Canada), Europe (Germany, France, the UK, Italy and rest of Europe), Asia-Pacific (Japan, China, Australia, India and rest of Asia-Pacific), and LAMEA (Latin America and Middle East & Africa).
The report provides a comprehensive analysis of the key players that operate in the global TAVR embolic protection market such Boston Scientific Corporation, Edward Lifesciences Corporation, Filterlex Medical Ltd., Innovative Cardiovascular Solutions, LLC., Protembis GmbH,Transverse Medical Inc., Emboline, Inc., Cardioptimus,EnCompass Technologies, Inc., and Venus MedTech HangZhou Inc. Key players operating in the market have adopted product approval, funding and clinical trials as their key strategies to expand their product portfolio.
Key Market Insights
- On the basis of product type, the SENTINEL Cerebral Protection System segment held the largest market share in 2022. However, the TriGUARD 3 CEP Device Technology segment is anticipated to grow at the fastest CAGR during the forecast period.
- Region-wise, North America generated the largest revenue in 2022. However, Asia-Pacific is anticipated to grow at the highest CAGR during the forecast period.
Companies Mentioned
- Protembis GmbH
- Innovative Cardiovascular Solutions, LLC.
- Filterlex Medical Ltd.
- Cardioptimus
- Transverse Medical Inc.
- Venus MedTech HangZhou Inc.
- EnCompass Technologies, Inc.
- Boston Scientific Corporation
- Edward Lifesciences Corporation
- Emboline, Inc.
Methodology
The analyst offers exhaustive research and analysis based on a wide variety of factual inputs, which largely include interviews with industry participants, reliable statistics, and regional intelligence. The in-house industry experts play an instrumental role in designing analytic tools and models, tailored to the requirements of a particular industry segment. The primary research efforts include reaching out participants through mail, tele-conversations, referrals, professional networks, and face-to-face interactions.
They are also in professional corporate relations with various companies that allow them greater flexibility for reaching out to industry participants and commentators for interviews and discussions.
They also refer to a broad array of industry sources for their secondary research, which typically include; however, not limited to:
- Company SEC filings, annual reports, company websites, broker & financial reports, and investor presentations for competitive scenario and shape of the industry
- Scientific and technical writings for product information and related preemptions
- Regional government and statistical databases for macro analysis
- Authentic news articles and other related releases for market evaluation
- Internal and external proprietary databases, key market indicators, and relevant press releases for market estimates and forecast
Furthermore, the accuracy of the data will be analyzed and validated by conducting additional primaries with various industry experts and KOLs. They also provide robust post-sales support to clients.
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