죽종절제 기기 시장 요약
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Atherectomy Devices Market Summary
Factors Contributing to the Growth of the Atherectomy Devices Market
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
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.
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
Atherectomy Devices Market Segmentation
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.
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.
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Key takeaways from the atherectomy devices market report study
Frequently Asked Questions for the Atherectomy Devices Market