미국의 심혈관 중재시술 기기 시장 : 시장 규모, 점유율, 동향 분석(2025-2031년)

The U.S. interventional cardiology device market was valued at nearly $4.4 billion in 2024. The market is projected to exceed $5.6 billion over the forecast period.

This report sizes and analyzes all core product categories used in percutaneous coronary intervention and related diagnostic workups, including coronary stents, coronary balloon catheters, balloon-inflation devices, interventional coronary catheters, interventional coronary guidewires, coronary embolic protection devices (EPDs), coronary atherectomy and intravascular lithotripsy (IVL) devices, coronary thrombectomy, coronary chronic total occlusion (CTO) systems, introducer sheaths, coronary vascular closure devices (VCDs), diagnostic coronary catheters and guidewires, coronary intravascular ultrasound (IVUS), coronary optical coherence tomography (OCT), and hemostasis valves.

Quantitative coverage includes unit sales, average selling prices, market values, growth rates, company shares, and procedure numbers.

Qualitative coverage includes market drivers and limiters, mergers and acquisitions, portfolio updates, and practical technology trends across hospitals and cath labs.

Market Overview

Interventional cardiology in the United States continues to evolve toward data-guided, image-rich, and workflow-efficient procedures. PCI volumes are expected to rise at a low single-digit rate, but device demand is shaped more by product mix than by raw volume alone.

Physicians use IVUS and OCT to size vessels, characterize plaque, and optimize stent expansion. This imaging-first approach influences selection of PTCA and specialty balloons, drug-eluting stents, and lesion preparation tools including atherectomy and IVL for calcified disease. At the same time, facilities face staffing constraints, price pressure, and contract consolidation.

These forces drive interest in bundled contracts, standardized trays, radial access, and closure devices that shorten recovery and turn rooms faster.

Over the forecast period, imaging will be more deeply integrated into planning and decision making, while stent and balloon platforms will continue to improve deliverability, profiles, and coating technologies to serve a broader range of lesions with predictable outcomes.

Market Drivers

New technological developments. Adoption of advanced cardiovascular imaging, including CT, MRI, IVUS, and OCT, improves lesion detection and procedural planning. Next-generation drug-eluting stents with refined construction and thinner drug coatings are expected to enhance effectiveness and broaden treatable lesion types.

High rate of research and development. A growing patient population attracts more participants across segments. Competition accelerates innovation in guidewires, micro-catheters, balloons, atherectomy, IVL, and closure devices, leading to faster and less invasive procedures with more consistent results.

Rising rates of diabetes. In 2021, about 11 percent of the U.S. population had diabetes. This disease burden raises the prevalence of coronary artery disease and supports steady PCI demand, particularly in complex lesions associated with diffuse atherosclerosis and calcification.

PCI procedure volume. PCI is projected to grow at a low single-digit rate. Even modest procedural expansion increases demand for stents, balloon catheters, interventional catheters, guidewires, and associated equipment used in each case.

Imaging-led optimization. Facilities invest in IVUS consoles, OCT platforms, and imaging catheters to reduce geographic miss, optimize stent expansion, and document results for quality programs and payers.

Radial access and recovery. Wider use of radial access supports patient comfort and shorter stays. This favors micro-introducers, radial-specific sheaths, and closure devices tailored to rapid hemostasis and early ambulation.

Lesion preparation tools. Complex calcified lesions drive use of atherectomy and IVL to improve deliverability and ensure full stent expansion, which reduces restenosis risk and repeat procedures.

Market Limiters

External market shortages. Skilled labor shortages affect both suppliers and providers. Production delays, longer service cycles, and staffing gaps in cath labs slow throughput and weight capital planning. These pressures also push the market toward automation and streamlined product choices.

Bundling and price pressure. Large competitors use broad portfolios to negotiate system-wide contracts covering stents, balloons, guidewires, catheters, and VCDs. Bundling simplifies procurement but compresses ASPs and challenges smaller manufacturers. As consolidation continues, steady price declines are expected in many categories.

Alternative treatment methods for CAD. Beyond PCI, patients and clinicians use rehab programs, medical therapy optimization, and personal self-management. Complementary and alternative approaches, self-testing, and drug advances can delay or substitute for interventions in some cases, dampening procedural growth.

Capital diligence for imaging. OCT and IVUS require upfront console investment and ongoing disposable costs. Some centers phase adoption while they evaluate utilization and reimbursement patterns.

Supply chain and regulatory friction. Portfolio refreshes and compliance steps can lengthen launch timelines and complicate inventory.

Market Coverage and Data Scope

Quantitative coverage. Market size, market shares, market forecasts, growth rates, units sold, average selling prices, and procedure numbers.

Qualitative coverage. Growth drivers and limiters, competitive analysis and SWOT for top competitors, mergers and acquisitions, company profiles and product portfolios, FDA recalls where applicable, disruptive technologies, and disease overviews that influence PCI care pathways.

Time frame. Base year 2024, forecasts 2025 to 2031, historical data 2021 to 2024.

Data sources. Primary interviews with industry leaders and physicians, government physician and procedure data, regulatory databases, hospital private data, import and export data, and the iData Research internal database.

Method note. Revenue is modeled from units multiplied by ASP and validated against PCI volumes, imaging adoption, access approach mix, and facility purchasing patterns across hospitals and integrated delivery networks.

Markets Covered and Segmentation

Coronary Stent Market

Device type. Bare-metal stent, drug-eluting stent, covered stent, bifurcated stent.

Single-year unit share breakdown by size. Diameter and length.

Coronary Balloon Catheter

Device type. PTCA balloon and specialty balloon.

Single-year unit share by classification. Compliant, semi-compliant, non-compliant.

Single-year unit share by indication. Pre-dilation and stent placement, post-dilation.

Balloon-Inflation Device

Interventional Coronary Catheter

Device type. Guiding catheter, extension guide catheter, micro-catheter.

Interventional Coronary Guidewire

Coronary Embolic Protection Device (EPD)

Coronary Atherectomy Device

Device type. Mechanical atherectomy, laser atherectomy, intravascular lithotripsy (IVL).

Coronary Thrombectomy

Coronary Chronic Total Occlusion (CTO) System

Device type. CTO guidewire, CTO catheter, CTO device.

Introducer Sheath

Device type. Standard introducer, micro-introducer.

By approach. Femoral, radial.

Coronary Vascular Closure Device (VCD)

Invasive VCD and non-invasive VCD.

Diagnostic Coronary Catheter and Guidewire

Device type. Diagnostic catheter, diagnostic guidewire, fractional flow reserve guidewire.

Coronary Intravascular Ultrasound (IVUS)

Device type. IVUS catheter, IVUS console.

Coronary Optical Coherence Tomography (OCT)

Device type. OCT catheter, OCT console.

Hemostasis Valve

Competitive Analysis

Boston Scientific was the leading competitor in 2024 with dominant positions in coronary stents, coronary balloon catheters, and coronary embolic protection devices. A new coronary drug-coated balloon is expected to support modest share expansion as adoption develops.

Abbott ranked second with a broad portfolio and frequent top positions across device categories. Abbott faces no direct competition in the OCT segment, which supports its standing across imaging-driven PCI strategies. The company is expected to maintain overall share.

ShockWave Medical ranked third and specializes in intravascular lithotripsy (IVL). IVL has been approved only in recent years but continues to expand quickly due to its ability to address calcified plaque in coronary vessels.

Other participants compete in selected stents, balloons, guidewires, catheters, VCDs, thrombectomy, and imaging. Competitive advantage reflects portfolio depth, radial access solutions, deliverability in tortuous anatomy, and the ability to tie imaging guidance to lesion preparation and device deployment.

Technology and Practice Trends

Imaging becomes procedural fabric. IVUS and OCT move from optional tools to routine guidance in many labs. Physicians rely on imaging to assess plaque morphology, calcification depth, and stent expansion. High-resolution CT supports pre-procedural planning in selected cases.

Calcium management. Growth in atherectomy and IVL reflects the need to treat heavily calcified lesions safely and predictably. These tools increase the likelihood of full stent expansion and durable outcomes.

Smarter balloons and stents. Specialty balloons with defined compliance and improved profiles, along with refined drug-eluting stents, help address complex anatomies and bifurcations while keeping procedure time under control.

Radial-first workflow. Facilities invest in radial introducers, micro-introducers, and closure solutions that support early ambulation and same-day discharge in appropriate patients.

Room efficiency. Staffing shortages push labs to standardize trays, streamline inflation devices, and select closure devices that reduce recovery time. Imaging-driven optimization also reduces repeat procedures and supports value-based targets.

Data and documentation. Imaging systems and consoles support case documentation for quality programs, peer review, and contracting, which strengthens the capital case for adoption.

Care Settings

Coverage includes hospitals, integrated delivery networks, and cath labs in academic and community settings. The report addresses procurement models that use direct purchase and group purchasing contracts, along with vendor-managed inventory where used.

Facility type influences access approach, imaging adoption, and preferences for bundled contracts.

Radial-first centers emphasize micro-introducers and closure products.

High-volume centers with complex case mix tend to invest earlier in IVUS and OCT and carry a wider range of atherectomy and IVL tools for calcium management.

Geography

This edition covers the United States.

Why This Report

Where is the largest and fastest growing opportunity within the U.S. interventional cardiology device market and how do stents, balloons, atherectomy, IVL, CTO systems, guidewires, catheters, EPDs, VCDs, IVUS, and OCT each contribute to value through 2031.

How does the interventional cardiology device market relate to the broader U.S. economy and hospital operations, including staffing constraints, capital planning for imaging, and purchasing strategies that favor bundles and standardization.

What forces will shape the market going forward, including growth in IVUS and OCT, refinement of drug-eluting stents, and the spread of radial access and same-day discharge pathways.

Which imaging modalities best support optimization in daily practice, and how should labs decide between IVUS and OCT based on case mix, reimbursement, and staff proficiency.

How will lesion preparation strategies evolve, and what is the right role for atherectomy versus IVL when treating severe calcification to ensure full expansion and reduce restenosis.

What mix of balloons is most effective across pre-dilation and post-dilation, and how do compliant, semi-compliant, and non-compliant profiles affect deliverability, safety, and consistency.

What is the expected balance between radial and femoral access, and how will this choice change demand for introducer sheaths, micro-introducers, closure devices, hemostasis valves, and accessory kits across hospitals and cath labs.

How will imaging choices evolve, in particular the adoption of OCT versus IVUS for lesion assessment, stent sizing, and post-deployment optimization, and what does this mean for console placements, disposable catheter pull-through, and training needs.

How will the next generation of drug-eluting stents and drug-coated balloons affect case selection and pricing, given the history of safety reviews and the emphasis on thinner struts, polymer changes, and controlled drug delivery.

What is the realistic trajectory for intravascular lithotripsy in calcified lesions, and how will IVL usage interact with atherectomy and high-pressure non-compliant balloons in complex PCI.

The U.S. interventional cardiology device market report from iData Research answers these questions with segment and setting models, company share analysis, pricing detail, and coverage that links imaging and access choices to device consumption.

Use it to size opportunities by category, plan product roadmaps, align contracting and inventory with hospital needs, and set targets for training and service that improve consistency across cath labs.

TABLE OF CONTENT

Table Of Contents

List Of Figures

List Of Charts

U.S. Interventional Cardiology Device Market Overview

Competitive Analysis

Market Developments

Market Trends

Procedure Segmentation

Procedure Codes Investigated

Market Segmentation

Key Report Updates

Version History

Research Methodology

• Step 1: Project Initiation & Team Selection
• Step 2: Prepare Data Systems And Perform Secondary Research
• Step 3: Preparation For Interviews & Questionnaire Design
• Step 4: Performing Primary Research
• Step 5: Research Analysis: Establishing Baseline Estimates
• Step 6: Market Forecast And Analysis
• Step 7: Identify Strategic Opportunities
• Step 8: Final Review And Market Release
• Step 9: Customer Feedback And Market Monitoring

Impact Of Global Tariffs

U.S. Interventional Cardiology Device Market Overview

• 3.1 Introduction
  • 3.1.1 Population At Risk
• 3.2 Market Overview & Trend Analysis
• 3.3 Drivers And Limiters
  • 3.3.1 Market Drivers
  • 3.3.2 Market Limiters
• 3.4 Competitive Market Share Analysis
• 3.5 Mergers And Acquisitions

Procedure Numbers

• 4.1 Introduction
• 4.2 Procedures
  • 4.2.1 Angiography Procedures
  • 4.2.2 Angioplasty/ Pci Procedures
  • 4.2.3 Coronary Atherectomy Procedures
  • 4.2.4 Coronary Chronic Total Occlusion Procedures
  • 4.2.5 Catheterization Procedures
  • 4.2.6 Coronary Intravascular Ultrasound Procedures
  • 4.2.7 Coronary Optical Coherence Tomography Procedures
  • 4.2.8 Fractional Flow Reserve Guidewire Procedures

Coronary Stent Market

• 5.1 Introduction
• 5.2 Market Overview
• 5.3 Market Analysis And Forecast
  • 5.3.1 Total Coronary Stent Market
  • 5.3.2 Bare-Metal Stent Market
  • 5.3.3 Drug-Eluting Stent Market
  • 5.3.4 Covered Stent Market
  • 5.3.5 Bifurcated Stent Market
• 5.4 Unit Analysis
  • 5.4.1 Coronary Stent Units Sold By Diameter
  • 5.4.2 Coronary Stent Units Sold By Length
• 5.5 Drivers And Limiters
  • 5.5.1 Market Drivers
  • 5.5.2 Market Limiters
• 5.6 Competitive Market Share Analysis

Coronary Balloon Catheter Market

• 6.1 Introduction
• 6.2 Market Overview
• 6.3 Market Analysis And Forecast
  • 6.3.1 Total Coronary Balloon Catheter Market
  • 6.3.2 Ptca Balloon Market
  • 6.3.3 Specialty Balloon Market
    • 6.3.3.1 Cutting Balloon Market
    • 6.3.3.2 Scoring Balloon Market
    • 6.3.3.3 Drug-Coated Balloon Market
  • 6.3.4 Coronary Balloon Catheter Units By Classification
  • 6.3.5 Coronary Balloon Catheter Units By Indication
• 6.4 Drivers And Limiters
  • 6.4.1 Market Drivers
  • 6.4.2 Market Limiters
• 6.5 Competitive Market Share Analysis

Balloon-Inflation Device Market

• 7.1 Introduction
• 7.2 Market Analysis And Forecast
• 7.3 Drivers And Limiters
  • 7.3.1 Market Drivers
  • 7.3.2 Market Limiters
• 7.4 Competitive Market Share Analysis

Interventional Coronary Catheter Market

• 8.1 Introduction
• 8.2 Market Overview
• 8.3 Market Analysis And Forecast
  • 8.3.1 Total Interventional Coronary Catheter Market
  • 8.3.2 Guiding Catheter Market
  • 8.3.3 Extension Guide Catheter Market
  • 8.3.4 Micro-Catheter Market
    • 8.3.4.1 Traditional Coronary Microcatheter Market
    • 8.3.4.1.1 Torqueable Traditional Coronary Microcatheter Market
    • 8.3.4.1.2 Braided Traditional Coronary Microcatheter Market
    • 8.3.4.2 Dual Lumen Specialty Coronary Microcatheter Market
• 8.4 Drivers And Limiters
  • 8.4.1 Market Drivers
  • 8.4.2 Market Limiters
• 8.5 Competitive Market Share Analysis

Interventional Coronary Guidewire Market

• 9.1 Introduction
  • 9.1.1 Device Construction
• 9.2 Market Analysis And Forecast
• 9.3 Drivers And Limiters
  • 9.3.1 Market Drivers
  • 9.3.2 Market Limiters
• 9.4 Competitive Market Share Analysis

Coronary Embolic Protection Device Market

• 10.1 Introduction
  • 10.1.1 Saphenous Vein Grafts
  • 10.1.2 Protection Mechanism
    • 10.1.2.1 Filter Basket
    • 10.1.2.2 Distal Balloon Occlusion
• 10.2 Market Analysis And Forecast
• 10.3 Drivers And Limiters
  • 10.3.1 Market Drivers
  • 10.3.2 Market Limiters
• 10.4 Competitive Market Share Analysis

Coronary Atherectomy Device Market

• 11.1 Introduction
  • 11.1.1 Device Technologies
    • 11.1.1.1 Mechanical Atherectomy
    • 11.1.1.2 Laser Atherectomy
    • 11.1.1.3 Directional Coronary Atherectomy (Dca)
    • 11.1.1.4 Intravascular Lithotripsy
• 11.2 Market Overview
• 11.3 Market Analysis And Forecast
  • 11.3.1 Total Coronary Atherectomy Device Market
  • 11.3.2 Mechanical Atherectomy Market
  • 11.3.3 Laser Atherectomy Market
  • 11.3.4 Intravascular Lithotripsy Market
• 11.4 Drivers And Limiters
  • 11.4.1 Market Drivers
  • 11.4.2 Market Limiters
• 11.5 Competitive Market Share Analysis

Coronary Thrombectomy Market

• 12.1 Introduction
  • 12.1.1 Drug-Eluting Stents And Thrombosis Treatment
• 12.2 Market Analysis And Forecast
• 12.3 Drivers And Limiters
  • 12.3.1 Market Drivers
  • 12.3.2 Market Limiters
• 12.4 Competitive Market Share Analysis

Coronary Chronic Total Occlusion System Market

• 13.1 Introduction
• 13.2 Market Overview
• 13.3 Market Analysis And Forecast
  • 13.3.1 Total Coronary Chronic Total Occlusion System Market
  • 13.3.2 Cto Guidewire Market
  • 13.3.3 Cto Catheter Market
  • 13.3.4 Cto Device Market
• 13.4 Drivers And Limiters
  • 13.4.1 Market Drivers
  • 13.4.2 Market Limiters
• 13.5 Competitive Market Share Analysis

Introducer Sheath Market

• 14.1 Introduction
• 14.2 Market Overview
• 14.3 Market Analysis And Forecast
  • 14.3.1 Total Introducer Sheath Market
  • 14.3.2 Standard Introducer Sheath Market
  • 14.3.3 Micro-Introducer Sheath Market
• 14.4 Introducer Sheath Units By Approach
• 14.5 Drivers And Limiters
  • 14.5.1 Market Drivers
  • 14.5.2 Market Limiters
• 14.6 Competitive Market Share Analysis

Coronary Vascular Closure Device Market

• 15.1 Introduction
• 15.2 Market Overview
• 15.3 Market Analysis And Forecast
  • 15.3.1 Total Coronary Vascular Closure Device Market
  • 15.3.2 Invasive Vcd Market
  • 15.3.3 Non-Invasive Vcd Market
    • 15.3.3.1 Topical Hemostat Market
    • 15.3.3.2 Radial Compression Band Market
    • 15.3.3.3 Femoral Compression Band Market
• 15.4 Drivers And Limiters
  • 15.4.1 Market Drivers
  • 15.4.2 Market Limiters
• 15.5 Competitive Market Share Analysis

Diagnostic Coronary Catheter & Guidewire Market

• 16.1 Introduction
• 16.2 Market Overview
• 16.3 Market Analysis And Forecast
  • 16.3.1 Total Diagnostic Coronary Catheter & Guidewire Market
  • 16.3.2 Diagnostic Catheter Market
  • 16.3.3 Diagnostic Guidewire Market
  • 16.3.4 Fractional Flow Reserve Guidewire Market
• 16.4 Drivers And Limiters
  • 16.4.1 Market Drivers
  • 16.4.2 Market Limiters
• 16.5 Competitive Market Share Analysis

Coronary Intravascular Ultrasound Market

• 17.1 Introduction
  • 17.1.1 Pre-Stenting Applications
  • 17.1.2 Post-Stenting Applications
  • 17.1.3 Ivus Penetration
• 17.2 Market Overview
• 17.3 Market Analysis And Forecast
  • 17.3.1 Ivus Catheter Market
  • 17.3.2 Ivus Console Market
• 17.4 Drivers And Limiters
  • 17.4.1 Market Drivers
  • 17.4.2 Market Limiters
• 17.5 Competitive Market Share Analysis

Coronary Optical Coherency Tomography Market

• 18.1 Introduction
• 18.2 Market Overview
• 18.3 Market Analysis And Forecast
  • 18.3.1 Oct Catheter Market
  • 18.3.2 Oct Console Market
• 18.4 Drivers And Limiters
  • 18.4.1 Market Drivers
  • 18.4.2 Market Limiters
• 18.5 Competitive Market Share Analysis

Hemostasis Valve Market

• 19.1 Introduction
• 19.2 Market Analysis And Forecast
• 19.3 Drivers And Limiters
  • 19.3.1 Market Drivers
  • 19.3.2 Market Limiters
• 19.4 Competitive Market Share Analysis

Abbreviations