Atherectomy Devices Market Size, Share, Growth, and Industry Analysis, By Types (Directional atherectomy, Rotational atherectomy, Orbital atherectomy, Laser atherectomy), By Applications Covered (Peripheral vascular, Cardiovascular, Neurovascular), Regional Insights and Forecast to 2033

Atherectomy Devices Market Size

The U.S. atherectomy devices market is set for strong growth, driven by the rising prevalence of peripheral artery disease (PAD), increasing adoption of minimally invasive procedures, and advancements in medical technology improving patient outcomes and procedural efficiency.

Key Findings

• Market Size: Valued at 1688.7M in 2025, expected to reach 3638.3M by 2033, growing at a CAGR of 10.07%.
• Growth Drivers: PAD prevalence over 50%, 30% increase in AI-guided procedures, 40% ASC adoption, 20% rise in diabetic vascular cases, 60% imaging integration.
• Trends: 60% image-guided adoption, 40% AI tool usage growth, 25% drug-coated combo use, 35% robotic procedures, 30% single-use devices preference.
• Key Players: Boston Scientific, Medtronic, Cardiovascular Systems, Avinger, Volcano
• Regional Insights: US performs 50% of global procedures, Europe 30% robotic growth, APAC 30% PAD rise, MEA allocates $15B in healthcare, Germany 100K procedures yearly.
• Challenges: 30% price hike in advanced systems, 25% limited reimbursement in EMs, 20% shortage of trained specialists, 35% regulatory approval delay rate, 15% cost barrier in clinics.
• Industry Impact: $2B tech investment, 45% AI adoption, 40% outpatient shift, 30% ISR treatment success boost, 35% reduction in reinterventions post-atherectomy.
• Recent Developments: Boston AI imaging up 30%, Medtronic robotic platform investment +$450M, CSI FDA clearance +25%, Avinger laser catheter launch +20%, Spectranetics EU DCB device deal +35%.

The atherectomy devices market is growing due to the rising prevalence of cardiovascular diseases (CVDs), peripheral artery disease (PAD), and critical limb ischemia (CLI). Atherectomy procedures are increasingly preferred over traditional methods due to their minimally invasive nature, reduced recovery time, and improved procedural outcomes. Advanced laser, orbital, and rotational atherectomy devices are being widely adopted in hospitals and ambulatory surgical centers. The market is witnessing technological innovations, including robotic-assisted atherectomy and AI-powered imaging integration, which enhance procedure precision and safety. Growing awareness and favorable reimbursement policies in developed regions are further driving the adoption of atherectomy devices.

Atherectomy Devices Market Trends

The atherectomy devices market is evolving with technological advancements, increasing prevalence of atherosclerosis, and rising adoption of minimally invasive vascular interventions. One of the most prominent trends is the shift towards image-guided atherectomy procedures, which enable real-time visualization of plaque composition and vessel structure. Over 60% of atherectomy procedures now incorporate angiography, intravascular ultrasound (IVUS), or optical coherence tomography (OCT) to improve treatment accuracy.

Another major trend is the integration of robotics in atherectomy procedures. Robotic-assisted atherectomy systems allow precision-guided navigation and controlled plaque removal, minimizing the risk of vessel injury. The use of AI-driven procedural planning tools has increased by over 40% in leading hospitals, improving success rates and reducing procedure time.

The growing prevalence of diabetes and obesity, both of which are risk factors for peripheral artery disease (PAD), has led to a significant increase in atherectomy procedures globally. Over 200 million people worldwide suffer from PAD, with a substantial percentage requiring revascularization therapies like atherectomy.

Additionally, the market is seeing a surge in drug-coated balloon (DCB) combination therapies, where atherectomy is performed before DCB angioplasty to improve drug absorption and long-term vessel patency. Hospitals and surgical centers are adopting cost-effective single-use atherectomy devices, which are gaining popularity due to reduced risk of cross-contamination and lower maintenance costs.

With the increasing number of outpatient and ambulatory surgical procedures, portable and catheter-based atherectomy devices are in high demand, enabling physicians to perform procedures in office-based labs (OBLs) and ambulatory surgery centers (ASCs).

Atherectomy Devices Market Dynamics

The atherectomy devices market is driven by rising cases of cardiovascular diseases, advancements in minimally invasive procedures, and increasing healthcare expenditure. However, challenges such as high device costs, reimbursement limitations, and the need for skilled professionals pose obstacles to growth. Opportunities exist in AI-powered atherectomy systems, robotic-assisted interventions, and combination therapies, while challenges include stringent regulatory approvals and supply chain constraints.

OPPORTUNITY

Growing Demand for Office-Based and Ambulatory Surgery Centers (ASCs)

With the increasing preference for outpatient-based treatments, atherectomy procedures are being widely performed in ASCs and office-based labs (OBLs). Over 40% of atherectomy procedures are now conducted outside traditional hospital settings, reducing patient hospital stays and overall healthcare costs. This trend is creating demand for portable and catheter-based atherectomy systems, making the procedure more accessible.

DRIVERS

Increasing Prevalence of Peripheral Artery Disease (PAD) and Cardiovascular Diseases (CVDs)

The rising incidence of atherosclerosis and PAD has led to an increase in minimally invasive revascularization procedures. Over 50% of patients diagnosed with PAD require interventional treatments like atherectomy to restore proper blood flow. According to clinical studies, over 8.5 million Americans suffer from PAD, contributing to higher demand for atherectomy devices.

Market Restraints

"High Cost of Atherectomy Devices and Procedures"

The cost of atherectomy devices remains a significant challenge, with advanced laser and orbital atherectomy systems priced at tens of thousands of dollars. The total procedural cost, including device usage, imaging, and post-procedure care, limits adoption in developing regions and small healthcare facilities. Many government-funded hospitals and smaller clinics find it difficult to invest in high-end atherectomy systems, restricting market penetration.

"Limited Reimbursement Policies in Certain Regions"

Despite growing awareness of atherectomy benefits, reimbursement coverage for PAD treatment and vascular interventions remains limited in developing countries. In some healthcare systems, alternative treatment methods like balloon angioplasty and stenting are prioritized over atherectomy procedures, reducing the adoption rate. Reimbursement delays and restrictive policies affect patient access to advanced atherectomy technologies.

Market Challenges

"Stringent Regulatory Approval Process for New Atherectomy Devices"

The approval process for new atherectomy devices is highly regulated, requiring extensive clinical trials and FDA/CE certifications before commercialization. Delays in regulatory approvals slow down the introduction of next-generation atherectomy technologies in global markets. Many startups and smaller manufacturers struggle with compliance requirements, limiting their ability to enter the market.

"Shortage of Skilled Physicians for Atherectomy Procedures"

Atherectomy requires specialized training and expertise, and only a limited number of interventional cardiologists and vascular surgeons are proficient in these procedures. In developing regions, access to trained professionals is even more restricted, leading to underutilization of atherectomy devices. Medical institutions are focusing on training programs and AI-assisted navigation tools to bridge the expertise gap in vascular interventions.

Segmentation Analysis

The atherectomy devices market is segmented by type and application, catering to various vascular conditions and treatment approaches. The type segment includes directional, rotational, orbital, and laser atherectomy devices, each offering distinct advantages based on plaque composition, vessel size, and procedural complexity. The application segment includes peripheral vascular, cardiovascular, and neurovascular interventions, where atherectomy devices play a crucial role in removing plaque build-up, restoring blood flow, and reducing the risk of stroke or limb amputation. As minimally invasive procedures gain traction, next-generation atherectomy devices with AI-driven imaging and real-time analytics are revolutionizing the market.

By Type

• Directional Atherectomy: Directional atherectomy devices are widely used for plaque removal in larger arteries, particularly in the lower extremities. These devices shave and collect plaque material for extraction, preventing embolization. Over 30% of peripheral atherectomy procedures utilize directional atherectomy, as it allows controlled tissue removal with minimal vessel trauma. Newer models integrate imaging technology, enhancing real-time procedural precision. Hospitals and ASCs prefer directional atherectomy for long-segment lesions and eccentric plaques, as it improves long-term vessel patency compared to balloon angioplasty alone.

• Rotational Atherectomy: Rotational atherectomy is highly effective for heavily calcified lesions, commonly seen in elderly patients with chronic coronary artery disease (CAD). These devices feature high-speed rotating burrs, which grind calcified plaque into microscopic particles that naturally pass through circulation. Over 25% of coronary atherectomy cases involve rotational atherectomy, as it allows better stent placement and reduces restenosis risks. The development of low-profile rotational atherectomy devices has improved accessibility in smaller coronary vessels, increasing procedural success rates.

• Orbital Atherectomy: Orbital atherectomy devices use an eccentric spinning mechanism, enabling 360-degree plaque modification. This method is highly effective in treating diffuse, severely calcified lesions in both peripheral and coronary arteries. Clinical studies show that orbital atherectomy improves lumen gain by over 50% compared to traditional methods. The ability to modulate rotational speeds makes orbital atherectomy a preferred choice for patients with high-risk calcium burdens. Many hospitals and surgical centers are integrating robotic-assisted orbital atherectomy systems, allowing enhanced precision and reduced procedural risks.

• Laser Atherectomy: Laser atherectomy devices use high-energy laser beams to vaporize plaque, offering a non-contact method for lesion removal. This approach is particularly useful for soft plaque and fibrotic lesions, commonly seen in diabetic patients and those with chronic total occlusions (CTOs). Laser atherectomy has a high success rate in treating in-stent restenosis (ISR), reducing the need for additional interventions. The integration of AI-driven laser modulation has improved procedural safety, ensuring precise tissue ablation with minimal vessel damage. The demand for portable laser atherectomy devices is rising, allowing for greater use in ambulatory and outpatient settings.

By Application

• Peripheral Vascular: Peripheral vascular applications account for over 40% of total atherectomy procedures, as peripheral artery disease (PAD) affects more than 200 million people globally. Patients with critical limb ischemia (CLI) often require atherectomy to restore blood flow and prevent amputations. Directional and orbital atherectomy devices are widely used in lower extremity interventions, ensuring better plaque clearance and reducing reintervention rates. The growing preference for outpatient-based atherectomy procedures is fueling the demand for catheter-based atherectomy solutions in ambulatory surgical centers (ASCs) and office-based labs (OBLs).

• Cardiovascular: Cardiovascular applications make up nearly 35% of the atherectomy device market, primarily driven by increasing cases of coronary artery disease (CAD). Rotational and orbital atherectomy devices are used to treat severely calcified coronary lesions, allowing successful stent placement and long-term vessel patency. Studies indicate that nearly 20% of angioplasty patients require atherectomy prior to stenting due to excessive plaque buildup. AI-integrated atherectomy devices are being developed to enhance real-time lesion assessment and procedural guidance, minimizing complications and improving treatment outcomes.

• Neurovascular: Neurovascular atherectomy procedures are growing, particularly in the treatment of carotid artery disease (CAD) and stroke prevention. Laser and orbital atherectomy devices are being tested for minimally invasive removal of intracranial atherosclerotic plaques, reducing stroke risk and improving cerebral blood flow. Over 15% of stroke-related interventions now involve image-guided atherectomy for high-risk patients, ensuring safer and more effective revascularization. With robotic-assisted neurovascular interventions gaining traction, next-generation atherectomy devices for cerebrovascular applications are expected to expand market opportunities.

Regional Outlook

The atherectomy devices market is experiencing steady growth across North America, Europe, Asia-Pacific, and the Middle East & Africa, driven by increasing cases of cardiovascular diseases (CVDs), advancements in minimally invasive procedures, and growing healthcare infrastructure. North America holds the largest share, owing to higher adoption of atherectomy procedures, strong reimbursement policies, and advanced medical facilities. Europe follows closely, with technological advancements and government-funded healthcare initiatives. Asia-Pacific is the fastest-growing region, fueled by rising healthcare investments, increasing awareness about PAD and CAD, and expanding medical tourism. The Middle East & Africa are also witnessing growth, with investments in modernizing healthcare systems and improving access to vascular treatments.

North America

North America dominates the atherectomy devices market, with the United States leading in adoption and innovation. Over 50% of global atherectomy procedures take place in the U.S., driven by high incidence rates of PAD and CAD. More than 18 million Americans suffer from PAD, creating strong demand for minimally invasive treatments. Medicare and private insurance reimbursements encourage wider adoption of atherectomy devices in hospitals and outpatient centers. Boston Scientific, Medtronic, and Cardiovascular Systems Inc. are among the key market players investing in AI-driven atherectomy solutions and robotic-assisted interventions to enhance procedure success rates and patient outcomes.

Europe

Europe is a highly developed market for atherectomy devices, with Germany, France, and the UK leading in vascular intervention procedures. Germany alone performs over 100,000 endovascular procedures annually, supporting high demand for atherectomy devices. The European Society of Cardiology (ESC) guidelines have increased adoption of image-guided atherectomy for coronary and peripheral interventions. Hospitals and specialized vascular clinics are implementing robotic-assisted atherectomy systems for enhanced precision. Additionally, public healthcare coverage in most EU countries supports reimbursement for advanced vascular procedures, further driving market expansion.

Asia-Pacific

Asia-Pacific is the fastest-growing market for atherectomy devices, with China, India, and Japan leading in cardiovascular treatments. China has over 245 million people with cardiovascular conditions, creating a huge demand for minimally invasive vascular interventions. Japan’s aging population is driving the use of robotic-assisted atherectomy and AI-powered imaging systems. India has seen a 30% increase in peripheral vascular procedures, with government initiatives supporting vascular disease treatment programs. Local and international companies are investing in affordable, portable atherectomy devices, expanding accessibility in developing economies.

Middle East & Africa

The Middle East & Africa are emerging markets for atherectomy devices, with Saudi Arabia, UAE, and South Africa leading the expansion. Saudi Arabia has allocated over $15 billion toward modernizing cardiovascular healthcare infrastructure, leading to increased investments in atherectomy procedures. The UAE is witnessing higher adoption of laser atherectomy devices in leading hospitals. In Africa, PAD and diabetes-related vascular diseases are rising, with South Africa investing in modern vascular care units. Limited awareness and healthcare affordability remain challenges, but international collaborations are helping improve access to minimally invasive cardiovascular procedures.

LIST OF KEY ATHERECTOMY DEVICES MARKET COMPANIES PROFILED

Investment Analysis and Opportunities

The atherectomy devices market is witnessing major investments as companies expand their R&D efforts, develop AI-driven atherectomy solutions, and enhance real-time imaging integration. In 2023, over $2 billion was invested in advanced atherectomy technologies, with a focus on robotic-assisted procedures and AI-powered lesion assessment tools.

Boston Scientific invested $500 million in developing next-generation orbital atherectomy systems, improving plaque removal efficiency and safety. Medtronic announced a $450 million R&D project to develop AI-based procedural planning software for atherectomy interventions. Startups and emerging medtech firms are also securing funding for portable, catheter-based atherectomy devices, making minimally invasive procedures more accessible in outpatient settings.

Government initiatives supporting vascular healthcare improvements are also fueling investments, with China, India, and Europe allocating funds for PAD treatment programs. The market presents significant opportunities in outpatient vascular centers, AI-driven atherectomy, and hybrid combination therapies integrating drug-coated balloon technology.

NEW PRODUCTS Development

Leading companies are launching new-generation atherectomy devices, incorporating robotics, AI, and enhanced imaging technology. Boston Scientific introduced a next-gen laser atherectomy system, featuring real-time AI analytics for plaque detection and procedural guidance. Medtronic developed a robotic-assisted orbital atherectomy platform, improving precision and reducing procedural complications.

Cardiovascular Systems Inc. launched a new peripheral orbital atherectomy device, designed for hard calcium removal in PAD patients. Avinger introduced a laser-guided atherectomy catheter, providing real-time intravascular imaging for improved lesion targeting. Spectranetics expanded its portfolio with a low-profile laser atherectomy catheter, allowing minimally invasive procedures in small and complex arteries.

With increasing demand for outpatient vascular procedures, companies are focusing on compact, portable atherectomy devices suitable for ambulatory surgical centers and office-based labs.

Recent Developments by Manufacturers

• Boston Scientific acquired an AI-based imaging company, enhancing its atherectomy device portfolio with AI-driven plaque analysis.
• Medtronic expanded its robotic-assisted vascular surgery division, integrating AI-powered real-time procedural guidance.
• Avinger launched a new catheter-based laser atherectomy system, designed for small-vessel interventions.
• Spectranetics partnered with a European medtech firm, developing next-gen drug-coated balloon-compatible atherectomy devices.
• Cardiovascular Systems Inc. received FDA clearance for an advanced orbital atherectomy device, improving calcium removal in complex vascular cases.

REPORT COVERAGE

The Atherectomy Devices Market Report provides comprehensive insights into market trends, technological advancements, and competitive landscape. It covers segmentation by type (Directional, Rotational, Orbital, Laser) and application (Peripheral Vascular, Cardiovascular, Neurovascular), analyzing growth factors, innovations, and market opportunities.

The report explores regional market trends, highlighting North America, Europe, Asia-Pacific, and the Middle East & Africa, with a focus on regulatory frameworks, reimbursement policies, and emerging technologies. The competitive landscape features leading players like Boston Scientific, Medtronic, and Cardiovascular Systems Inc., detailing their investment strategies, product launches, and technological advancements.

Additionally, the report provides investment insights, covering venture capital trends, hospital adoption rates of advanced atherectomy devices, and government-funded PAD treatment programs. Emerging trends in AI-driven atherectomy systems, robotic-assisted interventions, and drug-coated combination therapies are also explored, offering a data-driven outlook on the future of the atherectomy devices market.