PUBLISHER: iData Research Inc. | PRODUCT CODE: 1847184
PUBLISHER: iData Research Inc. | PRODUCT CODE: 1847184
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The U.S. complex peripheral vascular device market was valued at over $6.4 billion in 2024. The market is projected to grow to nearly $8.5 billion over the forecast period.
This report suite covers peripheral vascular stents, percutaneous transluminal angioplasty (PTA) balloon catheters, drug-coated balloons (DCBs), atherectomy devices, intravascular lithotripsy systems, chronic total occlusion (CTO) devices, surgical grafts, stent grafts, embolic protection devices, peripheral thrombus management devices, and peripheral intravascular ultrasound (IVUS) catheters.
While some devices have coronary applications, all sizing and forecasts in this edition address peripheral procedures only.
Quantitative coverage includes unit sales, average selling prices, market size, growth rates, procedure numbers, and company shares.
Qualitative coverage includes market drivers and limiters, mergers and acquisitions, technology and practice trends, and competitive positioning across hospitals, office based labs, and ambulatory settings that perform endovascular care.
Market Overview
Peripheral arterial and venous disease are major sources of morbidity in the United States.
Care pathways continue to shift from open surgery to endovascular treatment that allows shorter stays and faster recovery when clinically appropriate.
Within the arterial system, physicians rely on PTA balloons, DCBs, stents, atherectomy, IVUS, and lithotripsy to cross lesions, prepare the vessel, and maintain patency. In aortic and peripheral aneurysm care, stent grafts provide a minimally invasive alternative to open repair.
In venous disease, demand is rising for thrombectomy and embolization, venous stents, IVUS navigation, and protection from pulmonary embolism in selected cases. Growing awareness, better imaging, and more predictable tools are expanding the number of treatable patients and are improving outcomes.
Clinical programs also reflect practical constraints. Pricing pressure is most visible in office based labs where discounting and bundled offers are common.
Procurement choices depend on indication, setting, and evidence of durability, especially after concerns about paclitaxel safety reduced growth expectations for DCBs compared with pre-2019 trends.
The overall market remains diverse and innovation continues to add options, which supports steady value growth through the forecast period.
Market Drivers
Venous market development. Venous disease occurs at a rate roughly five times higher than arterial disease. Pulmonary embolism affects about 600,000 people in the United States each year and is often linked to deep vein thrombosis in the legs. DVT affects about 900,000 people annually, yet many patients are asymptomatic and sudden death can be the first sign in a meaningful share of cases. As education and screening improve, the number of patients treated for venous obstruction and thromboembolic disease will rise. IVUS already exceeds 50 percent penetration in deep venous procedures in some programs and is closely associated with treatment of iliac, iliofemoral, common femoral, and inferior vena cava lesions.
Growing public awareness. Outreach by medical institutions and public agencies has increased awareness of peripheral arterial and venous disease. Screening identifies more candidates for intervention before severe symptoms or limb-threatening ischemia develop. Stroke prevention programs highlight the role of carotid disease. These efforts move more patients into diagnostic and treatment pathways across arterial and venous categories.
Innovation. New options have expanded the toolkit since 2015. Intravascular lithotripsy and transcarotid artery revascularization (TCAR) add choices that can simplify difficult anatomy or reduce embolic risk. DCB indications continue to broaden in specific settings such as arteriovenous access, and below-the-knee DCB is expected to join the U.S. market. Thrombectomy platforms that reduce or eliminate thrombolytics shorten treatment time and reduce bleeding risk, including solutions that are cleared for pulmonary embolism. Stent graft indications continue to expand and covered stents, hydrophilic catheters, and guidewires command premium pricing where they reduce procedure time and complications.
Market Limiters
Paclitaxel safety concerns. A 2018 meta-analysis identified a late mortality signal in trials of paclitaxel-coated devices used for PAD. This prompted FDA scrutiny and a 2019 communication that supported continued use while calling for further study. The event triggered a sharp decline in DCB and drug-eluting stent volumes and a shift back to alternatives. Recovery is expected but long-term growth remains lower than before the re-evaluation.
Competition and pricing in OBLs. Office based labs purchase at prices that are already about 30 percent below hospital levels. Intense competition for OBL contracts and the use of bundled offers that include sheaths, guidewires, and catheters with core therapy devices drive average selling prices lower. Smaller firms without broad portfolios face pressure to discount, which can limit their ability to invest and may slow innovation if consolidation reduces market diversity.
Maturing femoral-popliteal segment. Years of focus on fem-pop disease have produced many treatment options and stable practices. As other indications develop and patient selection improves, growth in fem-pop interventions is expected to stabilize at a rate closer to overall procedural growth, rather than the rapid expansion seen earlier.
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 trends, market limiters, competitive analysis and SWOT for top competitors, mergers and acquisitions, company profiles and product portfolios, FDA clearances and recalls where applicable, disruptive technologies, and disease overviews that influence therapy selection.
Time frame. Base year 2024, forecasts 2025 to 2031, historical data 2021 to 2023.
Data sources. Primary interviews with industry leaders, government physician and procedure data, regulatory data, hospital and OBL inputs, import and export data, and the iData Research internal database.
Method note. Revenue is modeled from units multiplied by ASP and validated against installed base, procedure mix, setting shifts, and policy impacts.
Markets Covered and Segmentation
Peripheral Vascular Stent Market
Device type. Arterial stent and venous stent.
PTA Balloon Catheter Market
Device type. Standard, high-pressure, large, small, and specialty.
Unit analysis by application. Central venous or hemodialysis access, femoral-popliteal, iliac, infra-popliteal, renal, carotid, aorta, and others.
Drug-Coated Balloon Market
Indication. Superficial femoral artery, below the knee, and arteriovenous access.
Unit analysis by care setting. Hospital and office based lab.
Atherectomy Device Market
Device technology. Laser atherectomy device and mechanical atherectomy disposable.
Intravascular Lithotripsy Market
Care setting. Hospital and office based lab.
CTO Device Market
Device technology. Re-entry and re-canalization.
Surgical Graft Market
Indication. Lower limb, aorta repair, and extra-anatomical bypass.
Material. Polyester and PTFE.
Stent Graft Market
Device type. Abdominal aortic aneurysm, femoral or femoral access related applications, and thoracic aortic aneurysm.
Embolic Protection Device Market
Device type. Carotid and alternative.
Peripheral Thrombus Management Market
Device type. Traditional thrombectomy device, pharmacomechanical thrombectomy device, and catheter directed thrombolysis.
Indication. AV access, arterial, and venous.
Peripheral IVUS Market
Inferior Vena Cava Filter Market
Device type. IVC filter and IVC filter retrieval device.
Carotid Shunt
Transcarotid Artery Revascularization (TCAR) Market
Device type. Transcarotid bare-metal stent and TCAR neuroprotection system.
Diagnostic and Interventional Catheter Market
Device type. Diagnostic catheter and support catheter.
Diagnostic and Interventional Guidewire Market
Device type. Standard and hydrophilic.
Introducer Sheath Market
Device type. Standard and guiding.
Vascular Closure Device Market
Device type. Non-invasive and invasive.
Approach. Radial and femoral.
Transcatheter Embolization Market
Device type. Particle, coil, liquid, and plug.
Competitive Analysis
W. L. Gore led the total complex peripheral vascular device market in 2024 based on leadership in stent grafts and gains in covered stents following approval of the VBX iliac covered stent.
Medtronic ranked second with large revenue in stent grafts, DCBs, and atherectomy. The company led the DCB market and leveraged its portfolio across PTA, bare-metal stents, and atherectomy in hospitals and OBLs.
Boston Scientific ranked third following acquisitions that expanded its portfolio, including the BTG purchase. The company strengthened its venous portfolio with VICI venous stents while maintaining share with Wallstent and growing positions in oncology and deep vein thrombosis care.
Other participants compete across balloons, stents, atherectomy, thrombectomy, IVUS, lithotripsy, and closure.
Advantages come from portfolio breadth, performance, OBL pricing strategies, and support programs for vascular teams.
Technology and Practice Trends
IVUS integration in venous care. Deep venous programs use IVUS frequently to size and position venous stents and to evaluate obstructions.
Lithotripsy and vessel preparation. Calcium management using intravascular lithotripsy supports better expansion and reduces complications in difficult lesions.
Atherectomy and thrombus tools. Mechanical and laser systems are used to debulk plaque or remove clot where indicated, with growing interest in platforms that do not require thrombolytics.
Covered stents and stent grafts. Covered solutions gain share where they reduce restenosis, protect from embolization, or enable durable remodeling.
Procedure standardization. Programs create trays and protocols by indication and setting, which improves throughput and reduces variation.
Care Settings
Coverage includes hospitals, comprehensive vascular and stroke centers, community hospitals that perform elective endovascular procedures, office based labs that focus on peripheral interventions, and ambulatory settings that support specific cases.
Setting differences influence device selection, bundle adoption, service contracts, and achievable price corridors.
Geography
This edition covers the United States.
Where is the largest and fastest growing opportunity within the U.S. complex peripheral vascular device market and how do stents, balloons, DCBs, atherectomy, lithotripsy, CTO tools, stent grafts, thrombus management, IVUS, and closure each contribute to value through 2031.
How does the peripheral device market relate to the broader U.S. economy and to provider operations, including staffing, capital budgets, and the shift of procedures to office based labs.
What forces will shape the market going forward, including venous disease awareness, dialysis growth, calcium management, expanded stent graft indications, and the continued role of embolic protection in carotid pathways.
How should programs plan product selection for fem-pop, iliac, infra-popliteal, renal, carotid, and aortic indications, and what evidence supports the use of IVUS, covered stents, or vessel preparation in each setting.
What is the expected balance between hospital and OBL purchasing, and how will bundled pricing, inventory planning, and service agreements affect average selling prices and vendor selection.
How will paclitaxel concerns affect DCB adoption and revenue mix, and what alternatives are most likely to fill gaps in specific indications.
Where will venous stenting grow fastest, and how will May-Thurner and other obstruction patterns shape demand for venous stents and IVUS.
What is the outlook for thrombectomy in AV access, arterial, and venous indications, and how do devices that reduce thrombolytic use change case time, risk, and cost.
How can suppliers and providers build durable pathways, including standardized trays, staff training, and data tracking to support outcomes and economics.
Which risks could slow growth, including reimbursement pressure, ASP compression in OBLs, consolidation that reduces competition, and capacity limits for advanced endovascular skills.
The U.S. complex peripheral vascular device market report from iData Research answers these questions with segment and setting models, company share analysis, procedure and pricing detail, and coverage that links indication-specific choices to device demand.
Use it to size opportunities by category, plan product roadmaps, align OBL and hospital programs, and set targets for pricing, contracting, and inventory.
Table Of Contents
List Of Figures
List Of Charts
U.S. Complex Peripheral Vascular Device Market Overview
Competitive Analysis
Emerging Markets And Technologies
Market Developments
Market Trends
Procedure Segmentation
Procedure Codes Investigated
Market Segmentation
Key Analysis Updates
Version History
Research Methodology
Impact Of Global Tariffs
U.S. Complex Peripheral Vascular Device Market Overview
Procedure Numbers
Peripheral Vascular Stent Market
Pta Balloon Catheter Market
Drug-Coated Balloon Market
Atherectomy Device Market
Intravascular Lithotripsy Market
Cto Device Market
Surgical Graft Market
Stent Graft Market
Embolic Protection Device Market
Peripheral Thrombus Management Market
Peripheral Ivus Catheter Market
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