U.S. Aorto-iliac Occlusive Disease (Iliac Disease) Treatment Market Size, Share & Trends Analysis Report By Device Type (Endovascular Devices, Surgical Devices), By Procedure, By End-use (Hospitals, Outpatient Facilities), And Segment Forecasts, 2025 - 2030

Market Size & Trends   

The U.S. aorto-iliac occlusive disease (iliac disease) treatment market size was estimated at USD 716.6 million in 2024 and is projected to grow at a CAGR of 5.4% from 2025 to 2030. Increasing PAD incidence, rising government initiatives, and technological advancements drive market growth. For instance, in November 2024, Philips recently launched the THOR IDE clinical trial in the U.S. to evaluate a novel hybrid catheter system that combines laser atherectomy and intravascular lithotripsy.

The device is designed to treat severely calcified lesions commonly found in PAD and aorto-iliac disease. The first successful patient procedure, conducted at the Cardiovascular Institute of the South in Louisiana, demonstrates the potential for this device to streamline complex interventions and improve procedural outcomes. Increasing government initiatives drive market growth. According to the Congress.Gov article published in June 2023, the U.S. government took a significant step toward enhancing early detection and management of Peripheral Artery Disease (PAD), a primary contributor to Aorto-Iliac Occlusive Disease, through the introduction of the Arterial and Venous Comprehensive (ARC) Act. This legislation proposes amendments to the Social Security Act, aiming to ensure that Medicare and Medicaid beneficiaries identified as high-risk can access PAD screening without incurring out-of-pocket costs.

Covered diagnostic procedures include ankle-brachial index (ABI) tests and arterial duplex scans, which are critical for identifying PAD and assessing disease severity in the aorto-iliac region. Authorizing USD 6 million in annual funding from 2024 to 2028, the ARC Act seeks to improve early diagnosis and timely intervention, potentially reducing the burden of advanced occlusive conditions and boosting the demand for targeted treatment options such as iliac stenting and revascularization therapies. This initiative promotes preventive care and supports broader access to essential vascular health services.

The proliferation of ambulatory surgical centers (ASCs) and office-based labs (OBLs) across the U.S. significantly contributes to the growth in procedural volumes for vascular interventions, including those for aorto-iliac occlusive disease. These facilities offer a cost-effective and convenient alternative to traditional hospital settings, enabling quicker patient turnaround, reduced overhead costs, and enhanced scheduling flexibility for both patients and physicians. As a result, iliac artery interventions-such as balloon angioplasty, stenting, and atherectomy are increasingly being performed in ASCs and OBLs, especially for patients presenting with early to moderate stages of the disease. These minimally invasive procedures can often be completed on an outpatient basis, making them well-suited to these settings where shorter recovery times and lower procedural risk are prioritized. The shift toward these centers is also supported by favorable reimbursement policies, making them a preferred site of care for providers and payers.

Market Concentration & Characteristics

The U.S. market demonstrates a high degree of innovation in treating aorto-iliac occlusive disease, driven by continuous technological advancements, strong R&D pipelines, and a dynamic regulatory and reimbursement environment that supports novel therapies.

The U.S. market in peripheral arterial disease (PAD) and iliac artery interventions has seen a moderate to high level of M&A activity, driven by major players' strategic consolidation, technology acquisition, and portfolio expansion. Large companies such as Boston Scientific, Medtronic, Abbott, and BD (Becton Dickinson) have acquired smaller firms or product lines to strengthen their peripheral vascular portfolios.

U.S. regulatory frameworks exert a profound influence on the AIOD treatment landscape. While they ensure patient safety, product quality, and evidence-based care, they also introduce challenges related to approval timelines, compliance costs, and reimbursement uncertainties.

The U.S. market for aorto-iliac occlusive disease treatment is experiencing significant product and service expansion, driven by technological innovation, demand for minimally invasive solutions, and the growth of outpatient care models. This expansion encompasses new devices, procedural solutions, diagnostic services, and care delivery models, positioning the U.S. as a global leader in comprehensive vascular care.

Device Type Insights

The endovascular devices segment held the largest share of 87.8% in 2024. This segment represents a core pillar of vascular intervention, supporting a wide range of procedures to restore perfusion in patients with aorto-iliac and peripheral arterial disease. The demand for precise, adaptable, and durable devices has grown as endovascular techniques continue to replace open surgery in many scenarios. From simple lumen expansion using balloon angioplasty devices to advanced anatomical repair with bifurcated aortic stent grafts, this segment has evolved into a diverse portfolio that supports tailored treatment strategies across lesion types and complexities. In October 2023, an article published in Frontiers in Human Neuroscience evaluated the role of artificial intelligence in the autonomous navigation of catheters and guidewires for endovascular interventions. This systematic review analyzed 14 studies, most of which employed reinforcement learning and expert demonstration techniques using physical phantoms or in-silico models.

Balloon angioplasty remains a foundational technique, often used as a first-line approach or to prepare vessels before stent placement. The development of self-expanding and balloon-expandable stents has advanced procedural durability, with each type offering specific benefits depending on lesion location and vessel compliance. Covered stent grafts are increasingly used in high-risk occlusions or where vessel wall integrity is compromised. Though more specialized, atherectomy systems play a pivotal role in modifying calcified or heavily diseased lesions to enhance procedural success rates and long-term patency. These devices also help reduce the need for adjunctive procedures and minimize restenosis risk.

End-use Insights

The hospitals segment held the largest share of 49.2% in 2024. Hospitals provide comprehensive infrastructure, advanced technologies, and multidisciplinary expertise for managing complex vascular conditions. AIOD can cause serious complications such as critical limb ischemia, chronic pain, and tissue necrosis, which may become life-threatening without timely intervention. The growing demand for hospital-based treatment is further driven by the need for procedures that require high precision and post-procedure management. For instance, in November 2024, FV Hospital in Vietnam successfully treated a patient with severely calcified coronary arteries using the ROTAPRO system, operating at 160,000 RPM. Hospitals are uniquely equipped to provide such high-level care and advanced intervention due to access to cutting-edge technologies, expert healthcare professionals, and multidisciplinary teams skilled in managing complex vascular conditions, which reduce risk and recovery time in conditions such as AIOD.

Outpatient facilities are expected to grow at the fastest rate during the forecast period. Ambulatory surgical centers (ASCs) and specialized vascular clinics are increasingly equipped with modern imaging tools and endovascular equipment, allowing them to perform effective interventions for a growing patient base. Moreover, outpatient centers are more accessible regarding location and scheduling flexibility, which helps reduce care delays, an important factor in managing progressive vascular conditions such as AIOD.

Procedure Insights

In 2024, the endovascular procedure segment held the largest market share of 61.1%. Endovascular procedures have become a key component in managing aorto-iliac occlusive disease, favored for their reduced invasiveness and shorter recovery times. These approaches are especially suited for high-risk surgical candidates and are increasingly adopted as first-line interventions in less complex cases.

Techniques such as balloon angioplasty and primary stenting are commonly employed due to their procedural efficiency and ability to restore vessel patency with minimal trauma. In December 2024, the Journal of Cardiovascular Medicine and Surgery published a case report on LeRiche Syndrome involving aortoiliac and superficial femoral artery occlusion. The patient underwent combined aortoiliac stenting and superficial femoral artery angioplasty, resulting in significant symptom relief and restored femoral pulses. This report highlights the necessity of thorough vascular assessment and tailored treatment strategies for complex peripheral arterial disease cases.

The availability of device-specific strategies like kissing stents and covered stent grafts has enhanced outcomes in complex bifurcation or calcified lesions. These options allow tailored management of anatomically challenging disease, especially at the aortic bifurcation or in diffuse iliac involvement.

The hybrid procedures segment is expected to experience significant growth during the forecast period. Hybrid procedures combine open surgery and endovascular techniques to treat complex aorto-iliac occlusive disease, leveraging the strengths of both approaches. These procedures typically involve direct surgical exposure of vessels combined with catheter-based interventions such as angioplasty or stenting, allowing treatment of lesions that are difficult to address by either method alone. Hybrid approaches aim to reduce invasiveness while maintaining the durability of open repair, optimizing patient outcomes in high-risk or anatomically challenging cases.

Key U.S. Aorto-iliac Occlusive Disease (Iliac Disease) Treatment Company Insights

Some key established players operating in the market include Abbott, Boston Scientific Corporation, Medtronic, W. L. Gore & Associates, Inc., Terumo Corporation, and Cook. These companies are collaborating with regional players to expand their services geographically. iVascular, Limflow, and Vesper Medical are some emerging market participants. Emerging players focus more on collaborating with various research institutions to improve their clinical reach across the healthcare ecosystem.

Recent Developments

• In March 2024, Cook Medical entered into an exclusive distribution agreement with Getinge for the iCast covered stent system in the U.S. This collaboration aims to enhance the device's availability and distribution, which is indicated for the treatment of iliac arterial occlusive disease.

• In February 2023, Abbott announced the acquisition of Cardiovascular Systems Inc., a medical device company specializing in devices for treating coronary and peripheral artery diseases. This acquisition aimed to enhance Abbott's vascular device portfolio, particularly in treating complex peripheral artery disease cases.

• In May 2022, iVascular announced the beginning of a trial for its latest product, the advanced covered stent named iCover. This product is designated for treating de novo aortoiliac lesions in individuals experiencing symptomatic arteriopathy of the lower limbs.

U.S. Aorto-iliac Occlusive Disease Treatment Market Report Scope

U.S. Aorto-iliac Occlusive Disease Treatment Market Report Segmentation

This report forecasts revenue growth at a country level and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the U.S. aorto-iliac occlusive disease (iliac disease) treatment market report based on device type, procedure, and end-use:

• Device Type Outlook (Revenue, USD Million, 2018 - 2030)

  • Endovascular Devices

    • Balloon Angioplasty Devices

    • Atherectomy Systems

    • Stents

      • Self-Expanding Stents

      • Balloon-Expandable Stents

      • Covered Stent Grafts

      • Bifurcated Aortic Stent Grafts

  • Surgical Devices

• Procedure Outlook (Revenue, USD Million, 2018 - 2030)

  • Endovascular Procedures

    • Balloon Angioplasty

    • Primary Stenting

    • Kissing Stents

    • Covered Stent Grafts

    • Endovascular Aortic Repair (EVAR)

  • Hybrid Procedures

  • Open Surgical Procedures

• End-use Outlook (Revenue, USD Million, 2018 - 2030)

  • Hospitals

  • Outpatient Facilities

  • Others