회전식 절제 아테렉토미 시스템 시장 : 기술별, 시술 유형별, 제품 유형별, 동력원별, 적응증별, 용도별, 최종사용자별 - 세계 예측(2026-2032년)

The Rotational Excisional Atherectomy System Market was valued at USD 352.47 million in 2025 and is projected to grow to USD 384.24 million in 2026, with a CAGR of 8.53%, reaching USD 625.48 million by 2032.

Clinical demand and regulatory stewardship are driving refinement of device design, evidence generation, and value-focused procurement decisions across care settings

The Rotational Excisional Atherectomy System landscape is shifting as procedural complexity, device innovation, and cross-disciplinary collaboration converge to meet escalating clinical needs. Over the past several years, clinicians have sought devices that deliver precise plaque modification while minimizing procedural time and reducing downstream complications. This has driven device developers to refine cutting-tip geometries, enhance catheter trackability, and integrate adjunctive technologies that improve lesion crossability. As a result, decision-makers in hospitals and outpatient surgical centers evaluate new systems not only on acute performance metrics but also on total procedure workflow, staff training requirements, and device compatibility with existing imaging and hemodynamic monitoring platforms.

Concurrent with clinical drivers, regulatory authorities have placed greater emphasis on real-world evidence and post-market surveillance to validate device safety across diverse patient populations. Manufacturers have thus intensified investments in clinical registries and investigator-initiated studies to support device adoption and to provide the data clinicians need to update protocols. Payers and procurement teams are increasingly interested in comparative outcomes and resource utilization data that demonstrate value beyond the index procedure, prompting cross-functional dialogues among cardiac surgery, interventional cardiology, vascular medicine, and hospital supply chain teams. Taken together, these dynamics are shaping a market where clinical effectiveness, ease of use, and total cost of care are central to commercial success.

Converging innovations in device engineering, procedural imaging, and care delivery models are reshaping adoption pathways and commercial value propositions

Several transformative inflection points are accelerating change in the atherectomy systems space. First, iterative innovations in device materials and engineering have enhanced durability and precision, allowing operators to treat more complex and heavily calcified lesions with greater predictability. This technical progress is complemented by expanded procedural imaging capabilities, including intravascular imaging and hybrid fluoroscopic-imaging workflows, which together enable more targeted plaque modification and reduce reliance on empirical technique. Second, the increasing migration of cardiovascular procedures from inpatient to outpatient settings has influenced device development priorities, promoting compact, easier-to-manage systems that support same-day discharge pathways and reduced peri-procedural resource use. Third, new reimbursement models and heightened scrutiny over device-related costs have shifted conversations from acquisition price alone to bundled payment and episode-based performance, pushing manufacturers to document durable clinical improvements and return on procedural efficiency.

Moreover, an evolving competitive environment is fostering greater strategic alignment between device suppliers and clinical champions; partnerships now frequently include co-developed training curricula, virtual proctoring, and integrated post-market data collection to accelerate user proficiency and capture meaningful outcomes. Finally, demographic trends such as aging populations and the rising prevalence of diabetes and chronic kidney disease are increasing the prevalence of complex peripheral and coronary calcification, expanding the clinical imperative for more effective lesion modification solutions. These shifts are collectively reorienting product roadmaps, clinical trial designs, and commercial models toward more evidence-driven, procedure-centric offerings that can demonstrate measurable benefits in increasingly constrained healthcare budgets.

Tariff-driven supply chain adaptations and transparent contracting strategies are becoming pivotal to preserve device affordability and procurement relationships

The recent tariff environment in the United States has introduced new considerations for supply chain resilience and vendor selection. Tariffs on select medical device inputs and finished devices have elevated landed costs for companies that rely on cross-border manufacturing and component sourcing, prompting procurement teams to re-evaluate vendor contracts and total landed cost calculations. In response, manufacturers have accelerated efforts to localize certain manufacturing steps or to source alternate suppliers from tariff-exempt jurisdictions, thereby preserving competitive pricing while ensuring supply continuity. These supply chain adjustments have implications for lead times, inventory strategies, and capital allocation decisions for production capacity.

Additionally, the tariff-driven cost pressures have encouraged many sellers to pursue increased transparency in pricing and to develop flexible contracting arrangements that share risk with hospitals and group purchasing organizations. Some manufacturers have introduced consignment models, rolling inventory agreements, or multi-year fixed-price contracts to mitigate procurement uncertainty. From the clinical perspective, hospitals are prioritizing devices that demonstrate operational predictability and minimal requirement for supplementary disposables, since variability in accessory needs can magnify the financial impact of tariffs. Consequently, companies that can articulate a coherent plan to manage tariff exposure, while maintaining product quality and timely delivery, are positioned to strengthen relationships with major healthcare systems and to protect installed-base loyalty.

A multifaceted segmentation lens reveals how technology, procedure type, application, end-user profile, product design, power source, and clinical indication define commercialization pathways

The market segmentation framework illuminates where clinical need, technical development, and purchasing behavior intersect, and a nuanced read of these segments helps prioritize investment and commercialization strategies. Based on Technology, market participants are differentiating offerings across Laser and Mechanical modalities, with each pathway implying distinct capital equipment footprints, training pathways, and clinical use cases. Based on Procedure Type, systems are positioned for Orbital or Standard Rotational techniques, which influences engineering priorities such as ablation symmetry, lumen preservation, and device torque dynamics. Based on Application, product roadmaps address Coronary and Peripheral indications; the Coronary cohort is further refined into Acute Coronary Syndrome and Stable Angina, reflecting different urgency profiles and lesion characteristics, while the Peripheral cohort is further subdivided into Carotid and Lower Extremity applications, each carrying unique anatomic and access considerations.

Based on End User, purchasing and implementation vary across Ambulatory Surgical Centers, Clinics, and Hospitals; within Hospitals, procurement dynamics differ between Government and Private institutions, with implications for tendering processes and compliance. Based on Product Type, there is a clear delineation between Disposable and Reusable offerings, each presenting trade-offs in per-case cost, sterilization logistics, and device lifecycle planning. Based on Power Source, Electric and Pneumatic configurations present divergent operating requirements and maintenance profiles, which intersect with hospital infrastructure and biomedical engineering capabilities. Finally, based on Indication, devices are tailored for Calcified Lesions or Chronic Total Occlusion, and this clinical focus determines the extent of adjunctive imaging, cutting or ablation modalities, and operator training programs required to achieve reproducible outcomes. Understanding these segmentation axes enables targeted clinical studies, refined value messaging, and differentiated service models that align product features with the purchasing realities of end users.

Regional variations in healthcare infrastructure, reimbursement, and procedural volume necessitate tailored commercialization strategies and localized evidence generation

Regional dynamics demonstrate how differing healthcare infrastructure, reimbursement paradigms, and clinical practice patterns shape device adoption and market prioritization. In the Americas, there is a mature ecosystem of specialized cardiovascular centers, robust post-market registries, and a high degree of device uptake across both coronary and peripheral interventions; this drives demand for systems that offer procedural efficiency and evidence of clinical durability. In contrast, Europe, Middle East & Africa exhibit heterogeneous reimbursement landscapes and variable access to high-volume tertiary centers, which favors versatile systems that accommodate a wide range of clinical environments and that can be integrated into different care pathways with minimal infrastructure changes. In several jurisdictions across this region, centralized procurement and health technology assessment processes mean that clinical and economic evidence must be tailored to local HTA requirements to facilitate adoption.

Asia-Pacific demonstrates strong growth in procedural volumes driven by demographic shifts and rising investment in cardiovascular care capacity, and the region presents opportunities for scalable training programs and localized manufacturing partnerships that can lower delivery costs and improve market responsiveness. Across all regions, regulatory harmonization efforts and international clinical collaborations are moderating adoption timelines, but local reimbursement and practice patterns remain key determinants of where and how new systems are deployed. Consequently, commercial strategies should be regionally calibrated, balancing global evidence generation with locally relevant health economic narratives and training modalities that reflect provider workflows and infrastructure maturity.

Competitive differentiation increasingly hinges on integrated product ecosystems, clinician training, and robust post-market evidence to support durable adoption

The competitive profile of companies in the rotational excisional atherectomy domain reflects a spectrum of strategic choices, from specialization in narrow device classes to broad portfolios that integrate imaging, consumables, and service offerings. Leading companies differentiate through engineering refinements that enhance lesion modification precision, through investments in clinician training infrastructure, and through the assembly of robust post-market evidentiary programs that support differential value claims. Partnerships and strategic collaborations with hospital systems, academic centers, and contract manufacturers have become routine, enabling firms to scale clinical studies and to optimize manufacturing footprints.

Some companies emphasize modular systems that allow incremental upgrades and compatibility with existing cath lab equipment, reducing the friction for adoption. Others focus on disposable-centric strategies that simplify logistics for outpatient centers and reduce sterilization burdens. Service models also vary, with several players introducing remote proctoring, virtual training, and integrated data-collection platforms that tie procedural metrics to outcomes. For purchasers, competitive positioning is not only about device performance but also about the totality of support - training, warranty, and evidence generation. Firms that can demonstrate a cohesive ecosystem around their devices, including clear plans for regulatory compliance and long-term product stewardship, tend to build stronger clinical loyalty and more defensible commercial differentiation.

Actionable initiatives for device makers to strengthen clinical acceptance, procurement alignment, and supply chain resilience through coordinated investments and partnerships

Leaders in device development and commercialization should pursue a coordinated set of actions to capture clinical trust and procurement preference. First, prioritize investments in robust real-world evidence programs that align with the endpoints hospital administrators and payers value, such as procedural efficiency, complication reduction, and resource utilization. Second, design training curricula that combine hands-on skill development with digital learning modules and remote proctoring to accelerate operator competence while minimizing travel and scheduling burdens. Third, optimize product portfolios to offer clear contrasts between disposable and reusable models, and provide transparent lifecycle costing that addresses sterilization, consumable needs, and maintenance commitments.

Additionally, manufacturing resilience should be enhanced by diversifying supply bases and considering localized production for critical subassemblies to reduce exposure to tariff volatility and shipping disruptions. Commercial and clinical affairs teams should co-develop value dossiers and HTA-ready materials customized to priority regions, enabling faster reimbursement conversations and procurement approvals. Finally, invest in interoperable data platforms that link procedural metrics with patient outcomes, as this capability will become a decisive differentiator in payer discussions and hospital procurement committees. These actions, executed in parallel, will strengthen market access, improve clinician satisfaction, and create defensible competitive advantages.

A multi-method research approach integrating clinician interviews, clinical literature review, regulatory filings, and competitive intelligence to ensure evidence-based insights

The research methodology for this intelligence synthesis combined multiple complementary approaches to ensure a comprehensive and objective assessment. Primary research included structured interviews with interventional cardiologists, vascular surgeons, procurement executives, biomedical engineers, and clinical trialists to capture frontline perspectives on device performance, training needs, and purchasing drivers. These qualitative inputs were triangulated with a systematic review of peer-reviewed clinical literature, procedural registries, and regulatory filings to validate safety and effectiveness signals across a diversity of patient populations and anatomical applications.

Secondary research entailed analysis of public clinical trial registries, device approvals, and product IFUs to map device capabilities and indications. Competitive intelligence was gathered through product literature, investor presentations, and publicly available manufacturing footprints to understand strategic positioning and supply chain characteristics. To preserve rigor, data synthesis applied an evidence-weighting protocol prioritizing randomized and prospective registries for clinical claims while using real-world operational data to inform adoption and procedural workflow insights. Finally, expert validation panels reviewed interim findings to refine interpretation, highlight regional differences, and ensure the narrative accurately reflects clinical practice patterns and procurement dynamics.

Strategic convergence of engineering excellence, evidence generation, and commercial agility will determine winners in the evolving device landscape

In summary, the environment for rotational excisional atherectomy systems is evolving rapidly under the influence of technological refinement, shifting care delivery models, and heightened fiscal scrutiny. Clinicians and procurement teams now expect devices to deliver not only procedural efficacy but also demonstrable improvements in workflow efficiency and downstream resource utilization. Manufacturers that prioritize integrated evidence generation, flexible product design, and resilient supply chain strategies will be better positioned to establish clinical credibility and to meet the operational needs of a range of care settings. Region-specific approaches, supported by locally relevant health economic narratives and training programs, will be critical to accelerating adoption in diverse markets.

Moving forward, stakeholders should treat device introduction as a coordinated program that aligns engineering, clinical education, evidence planning, and commercial contracting. Doing so will reduce adoption friction, improve patient-centric outcomes, and enable procurement partners to make informed choices that reflect both clinical value and system-level financial constraints. The convergence of better engineered devices, richer clinical data, and adaptive commercial models presents a strategic opening for companies that can execute across these domains with discipline and clinical partnership.

Table of Contents

1. Preface

• 1.1. Objectives of the Study
• 1.2. Market Definition
• 1.3. Market Segmentation & Coverage
• 1.4. Years Considered for the Study
• 1.5. Currency Considered for the Study
• 1.6. Language Considered for the Study
• 1.7. Key Stakeholders

2. Research Methodology

• 2.1. Introduction
• 2.2. Research Design
  • 2.2.1. Primary Research
  • 2.2.2. Secondary Research
• 2.3. Research Framework
  • 2.3.1. Qualitative Analysis
  • 2.3.2. Quantitative Analysis
• 2.4. Market Size Estimation
  • 2.4.1. Top-Down Approach
  • 2.4.2. Bottom-Up Approach
• 2.5. Data Triangulation
• 2.6. Research Outcomes
• 2.7. Research Assumptions
• 2.8. Research Limitations

3. Executive Summary

• 3.1. Introduction
• 3.2. CXO Perspective
• 3.3. Market Size & Growth Trends
• 3.4. Market Share Analysis, 2025
• 3.5. FPNV Positioning Matrix, 2025
• 3.6. New Revenue Opportunities
• 3.7. Next-Generation Business Models
• 3.8. Industry Roadmap

4. Market Overview

• 4.1. Introduction
• 4.2. Industry Ecosystem & Value Chain Analysis
  • 4.2.1. Supply-Side Analysis
  • 4.2.2. Demand-Side Analysis
  • 4.2.3. Stakeholder Analysis
• 4.3. Porter's Five Forces Analysis
• 4.4. PESTLE Analysis
• 4.5. Market Outlook
  • 4.5.1. Near-Term Market Outlook (0-2 Years)
  • 4.5.2. Medium-Term Market Outlook (3-5 Years)
  • 4.5.3. Long-Term Market Outlook (5-10 Years)
• 4.6. Go-to-Market Strategy

5. Market Insights

• 5.1. Consumer Insights & End-User Perspective
• 5.2. Consumer Experience Benchmarking
• 5.3. Opportunity Mapping
• 5.4. Distribution Channel Analysis
• 5.5. Pricing Trend Analysis
• 5.6. Regulatory Compliance & Standards Framework
• 5.7. ESG & Sustainability Analysis
• 5.8. Disruption & Risk Scenarios
• 5.9. Return on Investment & Cost-Benefit Analysis

6. Cumulative Impact of United States Tariffs 2025

7. Cumulative Impact of Artificial Intelligence 2025

8. Rotational Excisional Atherectomy System Market, by Technology

• 8.1. Laser
• 8.2. Mechanical

9. Rotational Excisional Atherectomy System Market, by Procedure Type

• 9.1. Orbital
• 9.2. Standard Rotational

10. Rotational Excisional Atherectomy System Market, by Product Type

• 10.1. Disposable
• 10.2. Reusable

11. Rotational Excisional Atherectomy System Market, by Power Source

• 11.1. Electric
• 11.2. Pneumatic

12. Rotational Excisional Atherectomy System Market, by Indication

• 12.1. Calcified Lesions
• 12.2. Chronic Total Occlusion

13. Rotational Excisional Atherectomy System Market, by Application

• 13.1. Coronary
  • 13.1.1. Acute Coronary Syndrome
  • 13.1.2. Stable Angina
• 13.2. Peripheral
  • 13.2.1. Carotid
  • 13.2.2. Lower Extremity

14. Rotational Excisional Atherectomy System Market, by End User

• 14.1. Ambulatory Surgical Centers
• 14.2. Clinics
• 14.3. Hospitals
  • 14.3.1. Government
  • 14.3.2. Private

15. Rotational Excisional Atherectomy System Market, by Region

• 15.1. Americas
  • 15.1.1. North America
  • 15.1.2. Latin America
• 15.2. Europe, Middle East & Africa
  • 15.2.1. Europe
  • 15.2.2. Middle East
  • 15.2.3. Africa
• 15.3. Asia-Pacific

16. Rotational Excisional Atherectomy System Market, by Group

• 16.1. ASEAN
• 16.2. GCC
• 16.3. European Union
• 16.4. BRICS
• 16.5. G7
• 16.6. NATO

17. Rotational Excisional Atherectomy System Market, by Country

• 17.1. United States
• 17.2. Canada
• 17.3. Mexico
• 17.4. Brazil
• 17.5. United Kingdom
• 17.6. Germany
• 17.7. France
• 17.8. Russia
• 17.9. Italy
• 17.10. Spain
• 17.11. China
• 17.12. India
• 17.13. Japan
• 17.14. Australia
• 17.15. South Korea

18. United States Rotational Excisional Atherectomy System Market

19. China Rotational Excisional Atherectomy System Market

20. Competitive Landscape

• 20.1. Market Concentration Analysis, 2025
  • 20.1.1. Concentration Ratio (CR)
  • 20.1.2. Herfindahl Hirschman Index (HHI)
• 20.2. Recent Developments & Impact Analysis, 2025
• 20.3. Product Portfolio Analysis, 2025
• 20.4. Benchmarking Analysis, 2025
• 20.5. Abbott Laboratories
• 20.6. Avinger, Inc.
• 20.7. B. Braun SE
• 20.8. Bard Peripheral Vascular, Inc.
• 20.9. Boston Scientific Corporation
• 20.10. Cardinal Health, Inc.
• 20.11. Cardiovascular Systems, Inc.
• 20.12. Cook Medical LLC
• 20.13. Koninklijke Philips N.V.
• 20.14. Medtronic plc
• 20.15. Merit Medical Systems, Inc.
• 20.16. Philips
• 20.17. Rex Medical, LP
• 20.18. SJM Subsidiary Inc.
• 20.19. Spectranetics Corporation
• 20.20. Stryker Corporation
• 20.21. Terumo Corporation
• 20.22. Volcano Corporation