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栓塞防護裝置 (EPD) 市場：按產品類型、應用、最終用戶、地區劃分，2024-2031 年

Embolic Protection Device Market By Product Type, Application, End-User, & Region for 2024-2031

出版日期: 2024年07月01日 | 出版商:

Verified Market Research | 英文 202 Pages | 商品交期: 2-3個工作天內

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栓塞防護裝置 (EPD) 市場評估，2024-2031

由於多種變數，尤其是心血管疾病 (CVD) 盛行率的上升和微創手術的廣泛使用，對栓塞防護裝置 (EPD) 的需求不斷增加。冠狀動脈疾病、中風和周邊動脈疾病等心血管疾病是全球發病和死亡的主要原因，2024年銷售額將達到5.8648億美元，預計2031年將達到5.8648億美元。。

醫療實踐中向微創手術的轉變極大地增加了對栓塞防護系統的需求。經導管主動脈瓣置換術(TAVR) 和頸動脈支架置放術等微創手術優於傳統的開放性手術，因為具有恢復時間更快、住院時間更短、出現問題的可能性更低等優點，因此越來越受歡迎。

栓塞防護裝置 (EPD) 市場定義/概述

栓塞防護裝置 (EPD) 是一種在心血管治療過程中使用的醫療裝置，用於捕獲和清除可能脫落的碎片和栓塞顆粒，尤其是在動脈內。這些裝置通常用於頸動脈支架置放術 (CAS)、經皮冠狀動脈介入治療 (PCI) 和其他血管手術中，這些手術中存在清除斑塊、血栓或其他碎片的高風險。

它通常用於心血管治療，以避免栓塞碎片脫落，從而導致中風和重要動脈阻塞等嚴重問題。EPD 最重要的用途之一是頸動脈支架置放術 (CAS)，用於治療頸動脈疾病。頸動脈向大腦供應血液，在支架置入過程中，斑塊和其他顆粒可能會脫落並進入血液，可能導致中風等栓塞事件。

隨著心血管治療和醫療技術的進步，未來栓塞防護裝置 (EPD) 的使用預計將大幅增加。EPD 通常用於頸動脈支架置放術等血管手術中，以回收和清除介入期間可能脫落的碎片，從而降低栓塞性中風的風險。隨著世界人口老化和心血管疾病盛行率的增加，對更安全、更有效的介入技術的需求可能會增加。

老年人口的增加會推動栓塞防護裝置（EPD）市場嗎？

不斷增長的老年人口是栓塞防護設備（EPD）市場的主要推動因素。隨著人口老化，人們更容易患各種心血管疾病和疾病，這可能需要使用栓塞防護裝置（EPD）進行介入治療。據世界衛生組織(WHO)稱，2015年至2050年間，60歲及以上人口的比例將幾乎翻倍，從12%增至22%。這相當於60歲及以上的人口從9億增加到20億。光是在美國，人口普查局就預測，到 2030 年，所有嬰兒潮世代的年齡都將達到 65 歲或以上，即五分之一的老年人。

這一代際變化將對栓塞防護設備（EPD）市場產生重大影響。根據美國疾病管制與預防中心 (CDC) 的數據，心臟病仍然是 65 歲以上人口死亡的主要原因，佔該年齡層死亡人數的 25%。此外，根據美國心臟協會的數據，55 歲以後，中風的發生率每 10 年就會增加一倍。這些統計數據表明，老年族群發生心血管事件的風險較高，經常需要頸動脈支架置放術和經導管主動脈瓣置換術 (TAVR) 等治療。《Journal of the American College of Cardiology》發表的一項研究發現，在 TAVR 手術中使用栓塞保護裝置 (EPD) 可將中風風險降低 57%。

嚴格的監管架構會阻礙栓塞防護裝置（EPD）市場嗎？

嚴格的監管框架可能會嚴重阻礙栓塞防護裝置（EPD）市場的成長。EPD 對於減少心血管手術期間的栓塞事件至關重要，特別是對於接受頸動脈支架置放術或經導管主動脈瓣置換術的患者。然而，醫療器材產業監管嚴格，製造商必須經過複雜的監管流程，導致新產品上市延遲。美國食品藥物管理局 (FDA) 和歐洲藥品管理局 (EMA) 等監管機構制定了嚴格的要求，以確保這些設備的安全性和有效性。這些法規需要嚴格的臨床試驗、詳盡的文件記錄以及持續的上市後監督，這可能既耗時又昂貴。

法規因地區而異，可能會使商業環境變得複雜。歐盟的醫療器材法規 (MDR) 對臨床證據和上市後測試提出了更嚴格的標準，但 FDA 專注於上市前審批和持續監督，這為國際擴張帶來了困難。這種不匹配可能會導致產品發佈延遲並增加合規成本，從而限制市場擴張。此外，不斷更新以適應不斷變化的法規的需要可能會耗盡研發資源，並進一步限制創新。雖然這些嚴格的標準對於病人安全至關重要，但它們也無意中延遲了新穎且可能挽救生命的栓塞保護技術的可用性，限制了它們的採用，並破壞了整體可能減緩傳播的速度。

The need for embolic protection devices (EPDs) is increasing due to several variables, the most notable of which are the rising prevalence of cardiovascular diseases (CVDs) and the expanding use of minimally invasive surgery. Cardiovascular illnesses such as coronary artery disease, stroke, and peripheral artery disease are major sources of morbidity and mortality globally by enabling the market to surpass a revenue of USD 586.48 Million valued in 2024 and reach a valuation of aroundUSD 1022.85 Million by 2031.

The medical field's shift to minimally invasive procedures has greatly boosted demand for embolic protection systems. Minimally invasive methods such as transcatheter aortic valve replacement (TAVR) and carotid artery stenting are gaining popularity over traditional open surgeries due to their related benefits which include shorter recovery times, shorter hospital stays, and a lower chance of problems by enabling the market to grow at aCAGR of 7.20 % from 2024 to 2031.

Embolic Protection Device Market: Definition/ Overview

Embolic Protection Devices (EPDs) are medical equipment used to catch and remove debris or embolic particles that may become dislodged during cardiovascular treatments, particularly in the arteries. These devices are generally employed in procedures such as carotid artery stenting (CAS), percutaneous coronary interventions (PCI), and other vascular surgeries that have a high risk of dislodging plaque, thrombus, or other debris.

They are generally employed in cardiovascular treatments to avoid the migration of embolic debris which can lead to serious problems such as strokes or blockages in critical arteries. One of the most prominent uses for EPDs is in carotid artery stenting (CAS), a treatment used to treat carotid artery disease. The carotid arteries provide blood to the brain, and during stenting, plaque or other particles can dislodge and travel through the bloodstream, potentially causing an embolic event like a stroke.

The future use of embolic protection devices (EPDs) is expected to grow dramatically as advances in cardiovascular care and medical technology progress. EPDs are generally utilized during vascular procedures such as carotid artery stenting to collect and remove debris that may become dislodged during the intervention lowering the risk of an embolic stroke. As the world population ages and cardiovascular disease prevalence rises, there will be a greater demand for safer and more effective interventional methods.

Will the Growing Geriatric Population Drive the Embolic Protection Device Market?

The expanding geriatric population is a primary driver of the embolic protection device market. As people age, they become increasingly vulnerable to a variety of cardiovascular diseases and ailments that may necessitate interventional procedures involving embolic protection devices. According to the World Health Organization (WHO), the share of the world's population over 60 will nearly double between 2015 and 2050 from 12% to 22%. This equates to an increase of 900 million to 2 billion persons over the age of 60. In the United States alone, the Census Bureau predicts that by 2030, all baby boomers will be above the age of 65 growing the elder population to one in every five individuals.

This generational transition has major consequences for the embolic protection device market. According to the Centers for Disease Control and Prevention (CDC), heart disease continues to be the top cause of death among persons aged 65 and older accounting for 25% of all fatalities in this age range. Furthermore, the American Heart Association reports that the incidence of stroke doubles with each decade of life after the age of 55. These statistics show the senior population's higher risk of cardiovascular events which frequently require treatments such as carotid artery stenting or transcatheter aortic valve replacement (TAVR). Research published in the Journal of the American College of Cardiology discovered that using embolic protection devices during TAVR treatments decreased the risk of stroke by 57%.

Will Stringent Regulatory Framework Hamper the Embolic Protection Device Market?

Stringent regulatory frameworks can significantly impede the growth of the embolic protection device (EPD) market. EPDs are crucial for reducing embolic events during cardiovascular procedures, especially in patients having carotid artery stenting or transcatheter aortic valve replacement. However, due to the highly regulated nature of the medical device industry, manufacturers must navigate complex regulatory processes which can cause new product release delays. Regulatory authorities such as the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) set stringent requirements to ensure the safety and efficacy of these devices. These restrictions necessitate rigorous clinical trials thorough documentation, and ongoing post-market surveillance which can be time-consuming and expensive.

Regulations vary among regions which can complicate the business situation. While the European Union's Medical Device Regulation (MDR) has imposed stronger standards for clinical evidence and post-market inspection, the FDA's emphasis on pre-market approval and continuing monitoring creates a difficult environment for companies wanting to expand abroad. This mismatch might cause product launch delays and increased compliance costs limiting market expansion. Furthermore, the necessity for continual updates to suit changing rules might tap resources away from R&D restricting innovation even further. While these tight standards are vital for patient safety, they can unintentionally slow down the availability of novel and potentially life-saving embolic protection technologies limiting their adoption and slowing the overall expansion.

Category-Wise Acumens

Will Adoption and Effectiveness in Various Cardiovascular Procedures Drive Growth in the Product Type Segment?

Distal filter devices are currently the most dominant product type due to their broad use and effectiveness in a variety of cardiovascular treatments. Distal filter devices are intended to trap embolic debris downstream from the intervention site preventing it from reaching essential organs such as the brain or heart where it could cause catastrophic problems including strokes or myocardial infarctions. Their appeal arises from their capacity to maintain continuous blood flow while filtering out debris which is especially useful in complicated procedures such as carotid artery stenting. These devices are less invasive and easier to use than other types of EPDs making them popular among interventional cardiologists and vascular surgeons.

Furthermore, the form and functionality of distal filter devices help to explain their supremacy. They are frequently more adaptive and versatile allowing for usage in a variety of anatomical situations and procedural scenarios. This versatility is especially useful in the medical industry where patient diversity and procedural complexity necessitate flexible solutions. These devices are suited for a broader spectrum of patients including those with difficult vascular anatomy due to their ease of use and capacity to maintain perfusion throughout the surgery. Furthermore, the rising global frequency of cardiovascular illnesses has increased the demand for effective embolic protection during interventions and distal filter devices are well positioned to address this demand.

Will High Prevalence of Cardiovascular Conditions Drive the Application Segment?

The cardiovascular diseases segment is the most dominant application field owing to the high frequency of cardiovascular illnesses and the important necessity for embolic protection during interventional treatments. Cardiovascular diseases such as coronary artery disease and heart valve problems are major sources of morbidity and mortality worldwide. As a result, there is a high demand for procedures like angioplasty and stenting which are required to treat these problems. While these operations are lifesaving, there is a risk of embolic events which occur when debris dislodges and causes blockages in other sections of the circulatory system.

Furthermore, developments in interventional cardiology have increased the quantity and complexity of cardiovascular treatments driving up demand for EPDs. To avoid complications, innovations like transcatheter aortic valve replacement (TAVR) and sophisticated coronary operations require highly effective embolic protection. The increased use of these advanced procedures, particularly in elderly populations with significant cardiovascular risk highlights the importance of EPDs in this application area. Furthermore, the cardiovascular market benefits from significant investments in research and development resulting in the ongoing advancement of EPD technology.

Country/Region-wise Acumens

Will Rising Cases of Coronary Heart Disease Drive the Market in the North American Region?

The rising prevalence of coronary heart disease (CHD) in North America is driving the market for embolic protection devices. The United States dominates this market because of its advanced healthcare infrastructure, high healthcare spending, and expanding elderly population.

The increasing prevalence of coronary heart disease is a major driver of the embolic protection device market in North America. According to the Centers for Disease Control and Prevention (CDC), approximately 18.2 million adults aged 20 and up in the United States have CHD, accounting for 6.7% of the adult population.

The American Heart Association says that coronary heart disease is the top cause of mortality in the United States accounting for around 13% of all fatalities in 2019. According to the National Heart, Lung, and Blood Institute, the risk of getting coronary heart disease increases with age, especially beyond the age of 55 for women and 45 for men. With North America's aging population, this risk factor is likely to help drive market expansion. According to the United States Census Bureau, by 2030, all baby boomers will be over the age of 65 bringing the total elder population to 73 million people.

Will Improving Healthcare Infrastructure Drive the Market in the Asia Pacific Region?

The Asia Pacific region is seeing the highest growth in the embolic protection device market owing to significant improvements in healthcare infrastructure and increased investments in medical technology. This trend is especially noticeable in rising markets such as China and India. Governments around the Asia Pacific are dramatically expanding their healthcare budgets to enhance access to high-quality medical treatment. According to the World Health Organization, Chinese healthcare spending increased from 5.03% of GDP in 2010 to 6.57% in 2018. Similarly, India's healthcare spending increased from 3.27% to 3.54% of GDP over the same period.

This increasing funding allows hospitals and clinics to invest in modern medical technologies such as embolic protection devices. The Asia Pacific region is experiencing an increase in cardiovascular disease owing to changing lifestyles and an aging population. According to the World Heart Federation, cardiovascular disease accounts for 35% of all deaths in the Asia-Pacific area. Between 2010 and 2030, the number of persons suffering from cardiovascular disease in China is expected to increase by 50%. This increased disease burden is driving up demand for sophisticated therapeutic options such as embolic protection devices.

Competitive Landscape

The Embolic Protection Device Market is a dynamic and competitive space, characterized by a diverse range of players vying for market share. These players are on the run for solidifying their presence through the adoption of strategic plans such as collaborations, mergers, acquisitions, and political support. The organizations are focusing on innovating their product line to serve the vast population in diverse regions.

Some of the prominent players operating in the embolic protection device market include:

Boston Scientific Corporation

Edwards Lifesciences Corporation.

Abott.

Medtronic

Cardinal Health

Innovative Cardiovascular Solutions, LLC

Transverse Medical, Inc.

L. Gore & Associates, Inc.

Latest Developments

In September 2022, Boston Scientific Corporation revealed the results of a clinical trial on the PROTECTED TAVR to evaluate the SENTINEL Cerebral Protection System, which is designed to capture and eliminate embolic debris from transcatheter aortic valve replacement before it reaches the brain and potentially causes a stroke. Such advances served to maintain the company's brand image while also expanding its consumer base.

In April 2024, Emboline, Inc. announced the acquisition of SWAT Medical's Intellectual Property Portfolio for embolic protection. This acquisition is expected to broaden Emboline's existing portfolio of platform solutions for lowering the risk of stroke caused by the release of embolic debris into the bloodstream during operations like Transcatheter Aortic Valve Replacement (TAVR).