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市场调查报告书
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动脉粥状硬化斑块切除术器材：市场洞察、竞争格局及预测（至 2032 年）

Atherectomy Devices - Market Insights, Competitive Landscape, and Market Forecast - 2032
出版日期: | 出版商: DelveInsight | 英文 150 Pages | 商品交期: 2-10个工作天内

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动脉粥状硬化斑块切除术器械市场摘要

  • 全球动脉粥状硬化斑块切除术器械市场预计将从 2024 年的 10.3445 亿美元增长到 2032 年的 19.7843 亿美元，反映出强劲且持续的成长。
  • 预计在 2025 年至 2032 年的预测期内，其复合年增长率将达到 8.51%。
  • 全球动脉粥状硬化斑块切除术器械市场的成长主要受心血管疾病盛行率上升、微创手术普及以及技术不断进步的驱动。此外，患者对门诊治疗的偏好和意识提升也显着促进了市场扩张。
  • 在动脉粥状硬化斑块切除术设备市场营运的主要企业包括 Koninklijke Philips NV、Medtronic PLC、Boston Scientific Corporation、AngioDynamics Inc.、Abbott Laboratories、Avinger、BD、Ra Medical Systems、REX Medical 和 Cardio Flow, Inc.。
  • 预计到2024年，北美将占据全球动脉粥状硬化斑块切除术器械市场最大的份额。推动此市场成长的主要因素包括：心臟疾病和周边动脉疾病等心血管疾病的盛行率不断上升；肥胖、高血压和糖尿病的盛行率不断上升；人口老化加剧；以及各国政府加强对疾病治疗意识的倡议。预计这些因素将在预测期内推动该地区动脉粥状硬化斑块切除术器械市场的成长。
  • 根据产品类型，预计到 2024 年，定向动脉粥状硬化斑块切除术动脉粥状硬化斑块切除术类别将占据最大的市场份额。

动脉动脉粥状硬化斑块切除术器械市场成长要素

  • 心血管疾病 (CVD) 发病率上升推动市场扩张：市场成长要素是心血管疾病发生率的上升，尤其是周边动脉疾病(PAD) 和冠状动脉疾病 (CAD)。动脉粥状硬化斑块切除术装置用于清除血管中的动脉粥状硬化斑块（动脉粥状瘤），是治疗方法这些疾病的直接方法。以下因素导致了心血管疾病发生率的上升：
  • 人口老化加剧：世界人口老化自然会增加心血管疾病的风险。
  • 不健康的生活方式：久坐不动的生活方式、不良的饮食习惯、吸烟、糖尿病和日益严重的肥胖是动脉斑块积聚的主要危险因素。
  • 诊断率提高：多普勒超音波、血管造影术和 CT血管造影术等诊断技术的进步，使得动脉阻塞的诊断更加频繁和准确，从而增加了需要干预的患者数量。
  • 微创治疗的偏好：患者和医疗专业人员越来越倾向于选择微创手术而非传统开放性手术。动脉粥状硬化动脉粥状硬化斑块切除术是一种微创手术，具有许多优势，包括：
  • 缩短住院时间：患者通常可以更早出院，从而降低医疗成本。
  • 恢復时间更快：微创手术对身体造成的创伤较小，使患者更快恢復。
  • 併发症较少：与传统手术相比，术后感染疾病和撕裂等併发症的风险显着降低。
  • 技术进步：动脉动脉粥状硬化斑块切除术器械的持续技术创新是其关键成长要素。製造商正大力投资研发，以开发更精准、更有效、更安全的器材。主要技术趋势包括：
  • 改进的设备设计：更小、更通用的设备，具有不同类型的切割机制，包括定向切割、旋转切割、轨道切割和雷射切割，正在开发出来，以解决各种病变，包括高度钙化的斑块。
  • 整合成像和导航：使用血管内超音波(IVUS) 和光同调断层扫瞄(OCT) 等即时成像技术，可以在不增加辐射暴露的情况下更精确、更安全地清除斑块。
  • 人工智慧和机器人：将人工智慧和机器人技术应用于影像引导介入治疗，透过提供即时分析和智慧导航支持，提高了手术的效率、准确性和安全性。
  • 联合治疗：动脉粥状硬化斑块切除术越来越多地与其他治疗方法合併使用，例如药物涂层球囊（DCB）。动脉粥状硬化斑块切除术可以使血管为药物吸收做好准备，从而改善长期疗效并减少对支架等永久性植入的需求。

本报告调查了全球动脉粥状硬化斑块切除术设备市场，并提供了市场概况、市场影响因素和市场机会分析、法律制度、市场规模趋势和预测、按各个细分市场、地区/主要国家进行的详细分析、竞争格局以及主要企业的概况。

目录

第一章 动脉动脉粥状硬化斑块切除术器械市场：报告概述

  • 调查范围
  • 市场区隔
  • 市场假设

第二章 动脉动脉粥状硬化斑块切除术器械市场：执行摘要

  • 市场概览

第三章 动脉动脉粥状硬化斑块切除术器械市场：关键因素分析

  • 市场驱动因素
    • 心血管疾病（CVD）盛行率上升
    • 人们对微创手术的兴趣日益浓厚
    • 技术进步
    • 扩大门诊和门诊护理
  • 市场限制与挑战
    • 设备和手术高成本
    • 併发症和血管再阻塞风险
    • 存在其他治疗方案
  • 市场机会
    • 即时影像技术（血管内超音波、光学相干断层扫描等）与人工智慧和机器人技术的融合

第四章 影响分析

  • 人工智慧驱动的创新和应用
  • 美国关税的影响分析

第五章 监理分析

  • 美国
  • 欧洲
  • 日本
  • 中国

第六章 动脉动脉粥状硬化斑块切除术器械市场：波特五力分析

第七章 动脉动脉粥状硬化斑块切除术器械市场评估

  • 依产品类型
    • 定向动脉动脉粥状硬化斑块切除术装置
    • 旋转式动脉粥状硬化斑块切除术装置
    • 轨道动脉动脉粥状硬化斑块切除术装置
    • 雷射动脉动脉粥状硬化斑块切除术装置
  • 最终用户
    • 医院
    • 专科诊所
    • 其他的
  • 地区
    • 北美洲
    • 欧洲
    • 亚太地区
    • 其他地区

第八章 竞争情势

第九章Start-Ups资金筹措与投资趋势

第十章 动脉动脉粥状硬化斑块切除术器械市场公司及产品概况

  • Koninklijke Philips NV
  • Medtronic
  • Boston Scientific Corporation
  • AngioDynamics Inc.
  • Abbott Laboratories
  • Avinger
  • BD
  • Ra Medical Systems
  • REX Medical
  • Cardio Flow, Inc.

第十一章：KOL视角

第十二章计划方法

第十三章：关于 DelveInsight

第十四章 免责声明与咨询

Product Code: DIMDCL0313

Atherectomy Devices Market Summary

  • The global atherectomy devices market is expected to increase from USD 1,034.45 million in 2024 to USD 1,978.43 million by 2032, reflecting strong and sustained growth.
  • The global atherectomy devices market is growing at a CAGR of 8.51% during the forecast period from 2025 to 2032.
  • The growth of the global atherectomy devices market is driven by rising cardiovascular disease prevalence, increasing adoption of minimally invasive procedures, and continuous technological advancements. The preference for outpatient care and enhanced patient awareness also contribute significantly to market expansion.
  • The leading companies operating in the atherectomy devices market include Koninklijke Philips N.V., Medtronic PLC, Boston Scientific Corporation, AngioDynamics Inc., Abbott Laboratories, Avinger, BD, Ra Medical Systems, REX Medical, Cardio Flow, Inc., and others.
  • North America is expected to hold the largest share of the global atherectomy devices market in 2024. The key driving factors of the atherectomy devices market are the rising prevalence of cardiovascular diseases like coronary heart disease and peripheral arterial disease, the increasing prevalence of obesity, hypertension, and diabetes, and the rising aging population, along with the rising government initiatives regarding disease treatment awareness. These factors are expected to boost the market of atherectomy devices across the region during the forecasted period.
  • In the product type segment of the atherectomy devices market, the directional atherectomy devices category is estimated to account for the largest market share in 2024.

Factors Contributing to the Growth of the Atherectomy Devices Market

  • Rising Prevalence of Cardiovascular Diseases (CVDs) leading to a surge in the atherectomy devices market: The primary driver of the atherectomy devices market is the increasing incidence of cardiovascular diseases (CVDs), particularly Peripheral Artery Disease (PAD) and Coronary Artery Disease (CAD). Atherectomy devices are used to remove atherosclerotic plaque from blood vessels, which is a direct treatment for these conditions. Factors contributing to the rise of CVDs include:
  • Growing Aging Population: As the global population ages, the risk of developing cardiovascular issues naturally increases.
  • Unhealthy Lifestyles: Sedentary lifestyles, poor dietary habits, and rising rates of smoking, diabetes, and obesity are major risk factors that lead to plaque buildup in arteries.
  • Increased Diagnosis: Advancements in diagnostic technologies like Doppler ultrasound, angiography, and CT angiography are leading to more frequent and accurate diagnoses of arterial blockages, thus increasing the number of patients requiring intervention.
  • Preference for Minimally Invasive Procedures: Patients and healthcare professionals are increasingly favoring minimally invasive procedures over traditional open surgeries. Atherectomy is a minimally invasive procedure that offers numerous benefits, including:
  • Shorter Hospital Stays: Patients can often be discharged sooner, reducing healthcare costs.
  • Faster Recovery Times: Minimally invasive procedures cause less trauma to the body, leading to quicker patient recovery.
  • Reduced Complications: The risk of post-operative complications, such as infection or dissection, is significantly lower compared to traditional surgery.
  • Technological Advancements: Continuous innovation in atherectomy devices is a crucial growth factor. Manufacturers are investing heavily in research and development to create more precise, effective, and safer devices. Key technological trends include:
  • Improved Device Design: Development of smaller, more versatile devices with enhanced cutting mechanisms (e.g., directional, rotational, orbital, and laser atherectomy systems) to treat a wider range of lesion types, including highly calcified plaques.
  • Integration of Imaging and Navigation: The use of real-time imaging technologies, such as intravascular ultrasound (IVUS) and optical coherence tomography (OCT), allows for more precise and safer plaque removal without the need for additional radiation exposure.
  • AI and Robotics: The integration of AI and robotic technologies in image-guided interventions is improving procedural efficiency, precision, and safety by providing real-time analytics and intelligent navigation support.
  • Combination Therapies: The use of atherectomy in conjunction with other therapies, such as drug-coated balloons (DCBs), is gaining traction. Atherectomy can prepare the vessel for better drug absorption, improving long-term outcomes and reducing the need for permanent implants like stents.

Atherectomy Devices Market Report Segmentation

This atherectomy devices market report offers a comprehensive overview of the global atherectomy devices market, highlighting key trends, growth drivers, challenges, and opportunities. It covers detailed market segmentation by Product (Directional Atherectomy Devices, Rotational Atherectomy Devices, Orbital Atherectomy Devices, and Laser Atherectomy Devices), End-User (Hospitals, Specialty Clinics, and Others), and geography. The report provides valuable insights into the competitive landscape, regulatory environment, and market dynamics across major markets, including North America, Europe, and Asia-Pacific. Featuring in-depth profiles of leading industry players and recent product innovations, this report equips businesses with essential data to identify market potential, develop strategic plans, and capitalize on emerging opportunities in the rapidly growing atherectomy devices market.

Atherectomy devices are specialized medical instruments used in a minimally invasive procedure called atherectomy. The purpose of this procedure is to remove atherosclerotic plaque, which is a buildup of fat, cholesterol, calcium, and other substances that can narrow or block arteries. By removing this plaque, atherectomy devices help to restore proper blood flow and treat conditions such as Peripheral Artery Disease (PAD) and Coronary Artery Disease (CAD).

The rising prevalence of cardiovascular diseases and lifestyle disorders, such as diabetes and obesity, is driving the demand for atherectomy devices to treat atherosclerosis. Additionally, growing awareness and screening programs have led to earlier detection and diagnosis of arterial blockages, resulting in higher demand for atherectomy interventions. Furthermore, the advancements in atherectomy technology by key market players are improving precision and safety, making these devices more effective in treating complex cases. Together, these factors are fueling the growth of the global atherectomy device market. Collectively, these factors are expected to boost the market for atherectomy devices during the forecast period from 2025 to 2032.

What are the latest Atherectomy Devices Market Dynamics and Trends?

The rising global burden of cardiovascular diseases (CVDs) is a primary driver of the atherectomy devices market. According to a 2024 report by the British Heart Foundation, an estimated 200 million people worldwide were affected by coronary heart disease, and millions more were impacted by conditions such as stroke and congenital heart disease.

As CVDs often lead to atherosclerosis, the buildup of plaque in arteries, the demand for effective treatments is growing. Atherectomy devices, which remove this plaque to restore blood flow, are becoming an essential tool in managing conditions like coronary artery disease and peripheral artery disease, making them crucial for preventing the progression to more severe cardiac events like heart attacks and strokes.

Another key factor bolstering market growth is the increasing preference for minimally invasive procedures. Atherectomy devices offer significant advantages over conventional surgical methods, including faster healing times and less patient trauma. For instance, directional atherectomy is a minimally invasive treatment that effectively removes obstructive lesions without requiring the implantation of a permanent device like a stent. This helps patients avoid potential complications such as surgical scarring and post-stent inflammation. The inherent benefits of these systems are therefore expected to continue driving their adoption.

Furthermore, strategic business activities and ongoing technological advancements among key market players are fueling the market's expansion. For example, in September 2024, AngioDynamics, Inc., a leading medical technology company, received European CE Mark approval for its Auryon Atherectomy System. This innovative device is designed to treat Peripheral Artery Disease (PAD), including Critical Limb Ischemia (CLI) and In-Stent Restenosis (ISR), showcasing the continuous innovation within the market. These combined factors, rising disease prevalence, demand for minimally invasive solutions, and technological progress, are projected to propel the atherectomy devices market forward during the forecast period.

While the global atherectomy devices market is experiencing growth, several factors pose significant challenges. One major obstacle is the high cost associated with atherectomy systems and their procedures, which limits adoption in price-sensitive markets and healthcare settings with budget constraints. Another significant barrier is the risk of complications, such as vessel perforation or dissection, and the potential for restenosis (re-narrowing of the artery) post-procedure. The market also faces strong competition from alternative treatment options like balloon angioplasty, stenting, and drug-coated balloons, which are often more cost-effective and have extensive long-term clinical data. Furthermore, the limited availability of skilled interventional cardiologists and surgeons with expertise in performing these specialized procedures restricts their widespread adoption, particularly in developing regions.

Atherectomy Devices Market Segment Analysis

Atherectomy Devices Market by Product (Directional Atherectomy Devices, Rotational Atherectomy Devices, Orbital Atherectomy Devices, and Laser Atherectomy Devices), End-User (Hospitals, Specialty Clinics, and Others), and Geography (North America, Europe, Asia-Pacific, and Rest of the World)

By Product Type: Directional Atherectomy Devices Category Dominates the Market

In 2024, the directional atherectomy devices product type held the largest share, commanding approximately 40% of the global atherectomy devices market. This dominance is primarily attributed to their exceptional versatility and precision. Unlike other devices that are often better suited for specific lesion types, directional atherectomy systems can be effectively used to treat a wide variety of arterial blockages in both peripheral and coronary arteries. Their design, which features a blade within a housing, allows for the precise removal of eccentric and bulky plaque without causing significant damage to the healthy vessel wall. This selective plaque "debulking" not only addresses the immediate blockage but also prepares the artery for subsequent treatments, such as balloon angioplasty or drug-coated balloons, which can improve long-term patency rates and reduce the need for permanent stenting. Prominent directional atherectomy devices on the market include the HawkOne(TM) Directional Atherectomy System from Medtronic and the Jetstream(TM) Atherectomy System from Boston Scientific. While other devices like rotational and orbital atherectomy are highly effective for heavily calcified lesions, and laser atherectomy is useful for certain types of occlusions, the broader applicability and safety profile of directional atherectomy devices make them a preferred and widely adopted choice for a majority of clinical procedures, solidifying their leading position in the market.

Laser atherectomy devices are projected to witness the fastest growth in the global atherectomy devices market over the forecast period. The strong growth trajectory is attributed to their unique mechanism of action and expanding clinical applications in complex cardiovascular and peripheral vascular interventions. Unlike mechanical atherectomy systems, laser atherectomy technology utilizes focused, high-energy ultraviolet light to vaporize plaque and thrombus at the molecular level through a process called "photo-ablation." This approach is particularly effective for challenging lesion subsets such as chronic total occlusions (CTOs), in-stent restenosis (ISR), and long, diffuse blockages, where conventional atherectomy or balloon angioplasty often face limitations.

The rising adoption of laser atherectomy for vessel preparation is a key market driver. By creating a clear channel and modifying plaque morphology, the technology enhances the efficacy of subsequent procedures, including balloon angioplasty, drug-coated balloons (DCBs), and stent placement. This not only improves acute luminal gain but also enables superior drug absorption and better stent expansion, leading to lower rates of restenosis and improved long-term patient outcomes.

Market growth is further supported by ongoing technological advancements in laser atherectomy catheters, increasing operator familiarity, and growing clinical evidence validating its safety and efficacy. The increasing prevalence of peripheral artery disease (PAD) and coronary artery disease (CAD), coupled with the expanding elderly population and demand for minimally invasive procedures, is expected to accelerate market adoption globally. Additionally, favorable reimbursement policies in developed regions, alongside growing penetration in emerging economies, are strengthening the commercial outlook of the laser atherectomy devices market.

By End-User: Hospitals Dominate the Market

Hospitals accounted for a commanding 65% share of the global atherectomy devices market revenue in 2024, a dominance driven not merely by scale but by a combination of clinical, operational, and economic factors. Atherectomy procedures, though minimally invasive, are often performed in patients with complex cardiovascular and peripheral vascular conditions that demand the advanced infrastructure and resources only hospitals can provide. Equipped with state-of-the-art catheterization laboratories, intravascular imaging systems, and hybrid operating rooms, hospitals ensure the precision, safety, and success of atherectomy interventions.

Another key driver of hospital dominance is the availability of highly specialized, multidisciplinary care teams. Interventional cardiologists, vascular surgeons, and interventional radiologists collaborate in these settings to manage high-risk cases such as acute coronary syndrome, in-stent restenosis, and chronic total occlusions (CTOs), which require immediate and coordinated expertise. Hospitals also remain the primary destination for patients presenting with acute cardiac or peripheral ischemic events, where rapid atherectomy-based intervention can be lifesaving.

From an economic standpoint, hospitals are better positioned to invest in and maintain high-cost atherectomy systems, thanks to favorable reimbursement frameworks for advanced cardiovascular procedures in developed markets. Their role as referral centers for complex cases also ensures a higher patient volume, justifying the capital expenditure. Moreover, ongoing partnerships between hospitals, device manufacturers, and research institutions foster clinical trials and innovation adoption, further reinforcing their leadership role in the atherectomy devices end-user segment.

Looking forward, while ambulatory surgical centers (ASCs) and specialty clinics are expected to gradually increase their share due to the trend toward outpatient care, hospitals will continue to dominate the atherectomy devices market in the near to mid-term, given their unmatched infrastructure, patient volume, and clinical expertise.

Atherectomy Devices Market Regional Analysis

North America Atherectomy Devices Market Trends

North America is projected to maintain its position as the dominant regional market for atherectomy devices, with a significant market share of 42% in 2024. This leadership is fueled by a confluence of high disease burden, advanced healthcare infrastructure, and favorable economic conditions. The rising prevalence of cardiovascular diseases (CVDs) such as coronary heart disease and peripheral artery disease is a primary driver. Data from the Centers for Disease Control and Prevention (CDC) in 2024 highlights this, with millions of U.S. adults diagnosed with conditions like coronary heart disease and millions more affected by atrial fibrillation and stroke. The increasing incidence of these conditions, often linked to lifestyle factors like obesity and diabetes, directly translates into a greater need for interventional procedures that clear arterial blockages.

Diabetes, in particular, is a major contributor to this demand. With an estimated 38.4 million people in the U.S. having diabetes in 2024, the accelerated plaque buildup in their arteries often leads to peripheral artery disease. Atherectomy devices are critical in restoring circulation to the lower extremities, preventing severe complications like ulcers and amputations, thus significantly supporting market growth.

Furthermore, a robust ecosystem of technological innovation and market-driven activities distinguishes the North American market. The presence of leading medical device manufacturers and a strong focus on research and development result in a continuous pipeline of new and advanced products. For instance, in January 2025, the FDA cleared the Rotarex(TM) Atherectomy System via a 510(k) substantial equivalence determination (K242757). This clearance was specifically for revised Instructions for Use (IFU) aimed at reducing helix breakage; no changes were made to the physical device itself.

This combination of a high-risk population, a well-developed healthcare system, and a culture of innovation solidifies North America's leadership in the global atherectomy devices market.

Europe Atherectomy Devices Market Trends

The Europe atherectomy devices market is characterized by several key trends, primarily driven by a high prevalence of cardiovascular diseases (CVDs) within a rapidly aging population. As diseases of the circulatory system remain the leading cause of death in the EU, the demand for effective treatments like atherectomy is consistently growing. This is further supported by a strong regional preference for minimally invasive procedures, which offer advantages such as reduced patient trauma and faster recovery times, aligning with broader healthcare efficiency goals. A significant characteristic of the European market is the diversity in reimbursement policies across different countries; while major economies like Germany and France have robust reimbursement frameworks that encourage the adoption of these devices, variations in other nations can lead to a fragmented market landscape. Additionally, the market is a hub for continuous technological innovation, with medical device companies launching advanced products with enhanced safety and efficacy features. Strategic initiatives, such as securing crucial CE Mark approval for new devices, are essential for manufacturers seeking to expand their presence and capitalize on the promising growth opportunities in the European region.

Asia-Pacific Atherectomy Devices Market Trends

The Asia-Pacific atherectomy devices market is a rapidly expanding region and is projected to exhibit the fastest growth over the forecast period. This growth is driven by a combination of demographic shifts, improving healthcare infrastructure, and rising economic power.

Key Market Trends in Asia-Pacific

  • High and Growing Disease Burden: The Asia-Pacific region is home to a significant and aging population, which is a key demographic factor contributing to the rise of cardiovascular diseases, including PAD and CAD. Additionally, changing lifestyles, increasing rates of obesity, hypertension, and diabetes are fueling the prevalence of atherosclerosis and, consequently, the demand for atherectomy devices.
  • Rapid Development of Healthcare Infrastructure: Countries like China and India are making substantial investments in their healthcare systems. This includes building new hospitals, upgrading existing facilities with modern medical technologies, and training a new generation of skilled medical professionals. This infrastructural development is making advanced procedures like atherectomy more accessible to a larger patient base.
  • Increasing Disposable Income and Healthcare Spending: As the economies of countries in the region grow, so does the disposable income of their populations. This allows for greater personal spending on healthcare and the adoption of more advanced and expensive treatments. Governments are also increasing their healthcare budgets and promoting the use of innovative medical technologies to improve public health outcomes.
  • Growing Awareness and Patient Education: There is a growing awareness among both patients and healthcare providers in the region about the benefits of early diagnosis and minimally invasive treatment options for cardiovascular diseases. This is leading to a shift away from traditional, more invasive surgical methods towards modern procedures like atherectomy.
  • Fragmented but Evolving Regulatory Landscape: The regulatory environment in the Asia-Pacific region is complex and varies significantly by country. While countries like Japan, Australia, and Singapore have well-established and stringent regulatory bodies, others are still in the process of developing and refining their medical device regulations. However, there are ongoing efforts toward regulatory harmonization, which could streamline the market entry process for medical device manufacturers in the future.

Who are the major players in the Atherectomy Devices Market?

The following are the leading companies in the atherectomy devices market. These companies collectively hold the largest market share and dictate industry trends.

  • Koninklijke Philips N.V.
  • Medtronic
  • Abbott Laboratories
  • Boston Scientific Corporation
  • AngioDynamics
  • Avinger
  • BD
  • Ra Medical Systems
  • REX Medical
  • Cardio Flow, Inc.
  • Others

How is the competitive landscape shaping the Atherectomy Devices Market?

The competitive landscape of the atherectomy devices market is highly consolidated, with a few major players holding the dominant share. Companies like Medtronic, Boston Scientific, and Abbott are at the forefront, leveraging their extensive R&D capabilities, robust product portfolios, and global distribution networks. This has led to a strategic shift where these market leaders are engaging in significant acquisitions, such as Abbott's purchase of Cardiovascular Systems, Inc., to acquire new technologies and consolidate their market position. The primary competitive strategies revolve around continuous innovation, with a focus on developing multi-modality devices and integrating advanced imaging, as well as securing expanded regulatory approvals to treat a wider range of complex lesions. This high degree of concentration creates a dynamic environment where smaller, specialized innovators are either acquired by larger corporations or must find lucrative niche markets to compete effectively.

Recent Developmental Activities in the Atherectomy Devices Market

  • In January 2025, AngioDynamics also initiated a new clinical trial to further expand the system's indications for treating below-the-knee PAD.
  • In November 2024, Philips announced the enrollment of the first U.S. patient in a clinical trial for a combined laser atherectomy and intravascular lithotripsy catheter. This innovative, dual-function device is designed to simplify PAD treatment by integrating two therapies into a single procedure.
  • In September 2024, it received European CE Mark approval, allowing it to bring the solid-state laser technology to the European market for treating PAD, including critical limb ischemia and in-stent restenosis.
  • In April 2024, Avinger, Inc. received FDA 510(k) clearance for its Pantheris SV (Small Vessel) image-guided atherectomy system, a product line extension designed for smaller vessels.

Atherectomy Devices Market Segmentation

  • Atherectomy Devices Product Type Exposure
  • Directional Atherectomy Devices
  • Rotational Atherectomy Devices
  • Orbital Atherectomy Devices
  • Laser Atherectomy Devices
  • Atherectomy Devices End-User Exposure
  • Hospitals
  • Specialty Clinics
  • Others
  • Atherectomy Devices Geography Exposure
  • North America
  • United States
  • Canada
  • Mexico
  • Europe
  • United Kingdom
  • Germany
  • France
  • Italy
  • Spain
  • Rest of Europe
  • Asia-Pacific
  • China
  • Japan
  • India
  • Australia
  • South Korea
  • Rest of Asia-Pacific
  • Rest of the World
  • South America
  • Middle East
  • Africa

Impact Analysis

AI-Powered Innovations and Applications:

AI-powered innovations are poised to have a transformative impact on the atherectomy devices market by enhancing every stage of the procedure, from pre-procedural planning to real-time guidance and post-procedure analysis.

1. Enhanced Pre-Procedural Planning and Diagnostics: AI algorithms can analyze a patient's CT scans, angiography, and other imaging data to create detailed 3D models of the blood vessels. This allows clinicians to precisely characterize plaque composition (e.g., calcified vs. soft), identify the extent of the blockage, and even predict the most effective type of atherectomy device to use. This personalized approach to planning can significantly reduce procedure time and improve patient outcomes.

2. Real-time, AI-Guided Interventions: During the procedure, AI can be integrated with intravascular imaging technologies like IVUS and OCT. The AI software can analyze real-time images to provide instantaneous feedback to the clinician, such as identifying a vulnerable plaque segment, suggesting the optimal position for the device, and alerting the operator to potential risks like vessel dissection. This improves procedural accuracy and safety by reducing the risk of human error.

3. Robotics and Procedural Automation: AI is a key enabler for robotic-assisted atherectomy. Robotic systems, guided by AI, can offer enhanced dexterity and stability, allowing for more precise device manipulation, especially in challenging or torturous anatomy. By removing the clinician from the direct radiation field, these systems also improve safety for the medical staff. Future developments may even lead to semi-automated procedures where the AI assists in navigating the catheter and removing plaque with minimal human intervention.

4. Improved Post-Procedural Assessment: After the procedure, AI can analyze data collected from the atherectomy device and imaging systems to generate a comprehensive report on the treatment's effectiveness. This includes a quantitative analysis of plaque removal and an assessment of the restored blood flow. This data can be used to optimize follow-up care and predict long-term patency, ultimately improving patient management and reducing the likelihood of restenosis.

U.S. Tariff Impact Analysis on the Atherectomy Devices Market:

The imposition of U.S. tariffs is significantly impacting the global atherectomy devices market by raising costs and disrupting established supply chains. Even U.S.-based manufacturers, who rely heavily on imported components for their devices, face increased production costs that can either compress profit margins or be passed on to healthcare providers and patients. This economic pressure is compelling companies to re-evaluate their sourcing, with a growing trend towards reshoring or nearshoring production to mitigate tariff exposure. While this could lead to a more resilient domestic supply chain in the long term, it requires substantial investment and time. Furthermore, the tariffs are altering the competitive landscape by making it more expensive for foreign companies to export to the crucial U.S. market, potentially benefiting domestic manufacturers, but also exposing U.S. companies to retaliatory tariffs from other nations. This overall financial strain on the industry could ultimately slow the pace of research and development, which is critical for driving innovation and improving patient care.

How This Analysis Helps Clients

  • Cost Management: By understanding the tariff landscape, clients can anticipate cost increases and adjust pricing strategies accordingly, ensuring profitability.
  • Supply Chain Optimization: Clients can identify alternative sourcing options and diversify their supply chains to reduce dependency on high-tariff regions, enhancing resilience.
  • Regulatory Navigation: Expert guidance on navigating the evolving regulatory environment helps clients maintain compliance and avoid potential legal challenges.
  • Strategic Planning: Insights into tariff impacts enable clients to make informed decisions about manufacturing locations, partnerships, and market entry strategies.

Key takeaways from the atherectomy devices market report study

  • Market size analysis for the current atherectomy devices market size (2024), and market forecast for 8 years (2025 to 2032)
  • Top key product/technology developments, mergers, acquisitions, partnerships, and joint ventures happened over the last 3 years.
  • Key companies dominating the atherectomy devices market.
  • Various opportunities available for the other competitors in the atherectomy devices market space.
  • What are the top-performing segments in 2024? How these segments will perform in 2032?
  • Which are the top-performing regions and countries in the current atherectomy devices market scenario?
  • Which are the regions and countries where companies should have concentrated on opportunities for the atherectomy devices market growth in the future?

Frequently Asked Questions for the Atherectomy Devices Market

1. What is the growth rate of the atherectomy devices market?

  • The atherectomy devices market is estimated to grow at a CAGR of 8.51% during the forecast period from 2025 to 2032.

2. What is the market for atherectomy devices?

  • The atherectomy devices market was valued at USD 1,034.45 million in 2024, and is expected to reach USD 1,978.43 million by 2032.

3. Which region has the highest share in the atherectomy devices market?

  • North America is expected to hold the largest share of the global atherectomy devices market in 2024. The key driving factors of the atherectomy devices market are the rising prevalence of cardiovascular diseases like coronary heart disease and peripheral arterial disease, the increasing prevalence of obesity, hypertension, and diabetes, and the rising aging population, along with the rising government initiatives regarding disease treatment awareness. These factors are expected to boost the market of atherectomy devices across the region during the forecasted period.

4. What are the drivers for the atherectomy devices market?

  • The growth of the global atherectomy devices market is driven by rising cardiovascular disease prevalence, increasing adoption of minimally invasive procedures, and continuous technological advancements. The preference for outpatient care and enhanced patient awareness also contribute significantly to market expansion.

5. Who are the key players operating in the atherectomy devices market?

  • Some of the key market players operating in the atherectomy devices market include Koninklijke Philips N.V., Medtronic PLC, Boston Scientific Corporation, AngioDynamics Inc., Abbott Laboratories, Avinger, BD, Ra Medical Systems, REX Medical, Cardio Flow, Inc., and others.

Table of Contents

1. Atherectomy Devices Market Report Introduction

  • 1.1 Scope of the Study
  • 1.2 Market Segmentation
  • 1.3 Market Assumption

2. Atherectomy Devices Market Executive Summary

  • 2.1 Market at Glance

3. Atherectomy Devices Market Key Factors Analysis

  • 3.1 Atherectomy Devices Market Drivers
    • 3.1.1 Rising Prevalence of Cardiovascular Diseases (CVDs)
    • 3.1.2 Increasing Preference for Minimally Invasive Procedures
    • 3.1.3 Technological Advancements
    • 3.1.4 Expansion of Outpatient and Ambulatory Care Settings
  • 3.2 Atherectomy Devices Market Restraints and Challenges
    • 3.2.1 High Cost of the Devices and Procedures
    • 3.2.2 Risk of Complications and Restenosis
    • 3.2.3 Presence of Alternative Treatment Options
  • 3.3 Atherectomy Devices Market Opportunity
    • 3.3.1 Integrating real-time imaging technologies (e.g., IVUS and OCT) and incorporating AI and robotics

4. Impact Analysis

  • 4.1 AI-Powered Innovations and Applications
  • 4.2 U.S. Tariff Impact Analysis

5. Regulatory Analysis

  • 5.1 The United States
  • 5.2 Europe
  • 5.3 Japan
  • 5.4 China

6. Atherectomy Devices Market Porter's Five Forces Analysis

  • 6.1 Bargaining Power of Suppliers
  • 6.2 Bargaining Power of Consumers
  • 6.3 Threat of New Entrants
  • 6.4 Threat of Substitutes
  • 6.5 Competitive Rivalry

7. Atherectomy Devices Market Assessment

  • 7.1 By Product Type
    • 7.1.1 Directional Atherectomy Devices
    • 7.1.2 Rotational Atherectomy Devices
    • 7.1.3 Orbital Atherectomy Devices
    • 7.1.4 Laser Atherectomy Devices
  • 7.2 By End-User
    • 7.2.1 Hospitals
    • 7.2.2 Specialty Clinics
    • 7.2.3 Others
  • 7.3 By Geography
    • 7.3.1 North America
      • 7.3.1.1 United States Atherectomy Devices Market Size in USD million (2022-2032)
      • 7.3.1.2 Canada Atherectomy Devices Market Size in USD million (2022-2032)
      • 7.3.1.3 Mexico Atherectomy Devices Market Size in USD million (2022-2032)
    • 7.3.2 Europe
      • 7.3.2.1 France Atherectomy Devices Market Size in USD million (2022-2032)
      • 7.3.2.2 Germany Atherectomy Devices Market Size in USD million (2022-2032)
      • 7.3.2.3 United Kingdom Atherectomy Devices Market Size in USD million (2022-2032)
      • 7.3.2.4 Italy Atherectomy Devices Market Size in USD million (2022-2032)
      • 7.3.2.5 Spain Atherectomy Devices Market Size in USD million (2022-2032)
      • 7.3.2.6 Rest of Europe Atherectomy Devices Market Size in USD million (2022-2032)
    • 7.3.3 Asia-Pacific
      • 7.3.3.1 China Atherectomy Devices Market Size in USD million (2022-2032)
      • 7.3.3.2 Japan Atherectomy Devices Market Size in USD million (2022-2032)
      • 7.3.3.3 India Atherectomy Devices Market Size in USD million (2022-2032)
      • 7.3.3.4 Australia Atherectomy Devices Market Size in USD million (2022-2032)
      • 7.3.3.5 South Korea Atherectomy Devices Market Size in USD million (2022-2032)
      • 7.3.3.6 Rest of Asia-Pacific Atherectomy Devices Market Size in USD million (2022-2032)
    • 7.3.4 Rest of the World (RoW)
      • 7.3.4.1 Middle East Atherectomy Devices Market Size in USD million (2022-2032)
      • 7.3.4.2 Africa Atherectomy Devices Market Size in USD million (2022-2032)
      • 7.3.4.3 South America Atherectomy Devices Market Size In USD Million (2022-2032)

8. Competitive Landscape

9. Startup Funding & Investment Trends

10. Atherectomy Devices Market Company and Product Profiles

  • 10.1 Koninklijke Philips N.V.
    • 10.1.1 Company Overview
    • 10.1.2 Company Snapshot
    • 10.1.3 Financial Overview
    • 10.1.4 Product Listing
    • 10.1.5 Entropy
  • 10.2 Medtronic
    • 10.2.1 Company Overview
    • 10.2.2 Company Snapshot
    • 10.2.3 Financial Overview
    • 10.2.4 Product Listing
    • 10.2.5 Entropy
  • 10.3 Boston Scientific Corporation
    • 10.3.1 Company Overview
    • 10.3.2 Company Snapshot
    • 10.3.3 Financial Overview
    • 10.3.4 Product Listing
    • 10.3.5 Entropy
  • 10.4 AngioDynamics Inc.
    • 10.4.1 Company Overview
    • 10.4.2 Company Snapshot
    • 10.4.3 Financial Overview
    • 10.4.4 Product Listing
    • 10.4.5 Entropy
  • 10.5 Abbott Laboratories
    • 10.5.1 Company Overview
    • 10.5.2 Company Snapshot
    • 10.5.3 Financial Overview
    • 10.5.4 Product Listing
    • 10.5.5 Entropy
  • 10.6 Avinger
    • 10.6.1 Company Overview
    • 10.6.2 Company Snapshot
    • 10.6.3 Financial Overview
    • 10.6.4 Product Listing
    • 10.6.5 Entropy
  • 10.7 BD
    • 10.7.1 Company Overview
    • 10.7.2 Company Snapshot
    • 10.7.3 Financial Overview
    • 10.7.4 Product Listing
    • 10.7.5 Entropy
  • 10.8 Ra Medical Systems
    • 10.8.1 Company Overview
    • 10.8.2 Company Snapshot
    • 10.8.3 Financial Overview
    • 10.8.4 Product Listing
    • 10.8.5 Entropy
  • 10.9 REX Medical
    • 10.9.1 Company Overview
    • 10.9.2 Company Snapshot
    • 10.9.3 Financial Overview
    • 10.9.4 Product Listing
    • 10.9.5 Entropy
  • 10.10 Cardio Flow, Inc.
    • 10.10.1 Company Overview
    • 10.10.2 Company Snapshot
    • 10.10.3 Financial Overview
    • 10.10.4 Product Listing
    • 10.10.5 Entropy

11. KOL Views

12. Project Approach

13. About DelveInsight

14. Disclaimer & Contact Us

List of Tables

  • Table 1: Atherectomy Devices Market in Global (2022-2032)
  • Table 2: Atherectomy Devices Market in Global by Product Type (2022-2032)
  • Table 3: Atherectomy Devices Market in Global by End-User (2022-2032)
  • Table 4: Atherectomy Devices Market in Global by Geography (2022-2032)
  • Table 5: Atherectomy Devices Market in North America (2022-2032)
  • Table 6: Atherectomy Devices Market in the United States (2022-2032)
  • Table 7: Atherectomy Devices Market in Canada (2022-2032)
  • Table 8: Atherectomy Devices Market in Mexico (2022-2032)
  • Table 9: Atherectomy Devices Market in Europe (2022-2032)
  • Table 10: Atherectomy Devices Market in France (2022-2032)
  • Table 11: Atherectomy Devices Market in Germany (2022-2032)
  • Table 12: Atherectomy Devices Market in United Kingdom (2022-2032)
  • Table 13: Atherectomy Devices Market in Italy (2022-2032)
  • Table 14: Atherectomy Devices Market in Spain (2022-2032)
  • Table 15: Atherectomy Devices Market in the Rest of Europe (2022-2032)
  • Table 16: Atherectomy Devices Market in Asia-Pacific (2022-2032)
  • Table 17: Atherectomy Devices Market in China (2022-2032)
  • Table 18: Atherectomy Devices Market in Japan (2022-2032)
  • Table 19: Atherectomy Devices Market in India (2022-2032)
  • Table 20: Atherectomy Devices Market in Australia (2022-2032)
  • Table 21: Atherectomy Devices Market in South Korea (2022-2032)
  • Table 22: Atherectomy Devices Market in Rest of Asia-Pacific (2022-2032)
  • Table 23: Atherectomy Devices Market in the Rest of the World (2022-2032)
  • Table 24: Atherectomy Devices Market in the Middle East (2022-2032)
  • Table 25: Atherectomy Devices Market in Africa (2022-2032)
  • Table 26: Atherectomy Devices Market in South America (2022-2032)
  • Table 27: Competitive Landscape
  • Table 28: Startup Funding & Investment Trends

List of Figures

  • Figure 1: Atherectomy Devices Market Drivers
  • Figure 2: Atherectomy Devices Market Restraints
  • Figure 3: Atherectomy Devices Market Opportunities
  • Figure 4: AI-Powered Innovations in Atherectomy Devices Market
  • Figure 5: US Tariff Impact on Atherectomy Devices Market
  • Figure 6: Regulatory Analysis (US, EU, Japan, China)
  • Figure 7: Porter's Five Forces Analysis
  • Figure 8: Competitive Analysis
  • Figure 9: Atherectomy Devices Market in Global (2022-2032)
  • Figure 10: Atherectomy Devices Market in Global by Product Type (2022-2032)
  • Figure 11: Atherectomy Devices Market in Global by End-User (2022-2032)
  • Figure 12: Atherectomy Devices Market in Global by Geography (2022-2032)
  • Figure 13: Atherectomy Devices Market in North America (2022-2032)
  • Figure 14: Atherectomy Devices Market in the United States (2022-2032)
  • Figure 15: Atherectomy Devices Market in Canada (2022-2032)
  • Figure 16: Atherectomy Devices Market in Mexico (2022-2032)
  • Figure 17: Atherectomy Devices Market in Europe (2022-2032)
  • Figure 18: Atherectomy Devices Market in France (2022-2032)
  • Figure 19: Atherectomy Devices Market in Germany (2022-2032)
  • Figure 20: Atherectomy Devices Market in United Kingdom (2022-2032)
  • Figure 21: Atherectomy Devices Market in Italy (2022-2032)
  • Figure 22: Atherectomy Devices Market in Spain (2022-2032)
  • Figure 23: Atherectomy Devices Market in the Rest of Europe (2022-2032)
  • Figure 24: Atherectomy Devices Market in Asia-Pacific (2022-2032)
  • Figure 25: Atherectomy Devices Market in China (2022-2032)
  • Figure 26: Atherectomy Devices Market in Japan (2022-2032)
  • Figure 27: Atherectomy Devices Market in India (2022-2032)
  • Figure 28: Atherectomy Devices Market in Australia (2022-2032)
  • Figure 29: Atherectomy Devices Market in South Korea (2022-2032)
  • Figure 30: Atherectomy Devices Market in Rest of Asia-Pacific (2022-2032)
  • Figure 31: Atherectomy Devices Market in the Rest of the World (2022-2032)
  • Figure 32: Atherectomy Devices Market in the Middle East (2022-2032)
  • Figure 33: Atherectomy Devices Market in Africa (2022-2032)
  • Figure 34: Atherectomy Devices Market in South America (2022-2032)
  • Figure 35: Competitive Landscape
  • Figure 36: Startup Funding & Investment Trends