Aortic Stent Grafts Market - Global Forecast 2025-2030

The Aortic Stent Grafts Market size was estimated at USD 1.06 billion in 2024 and expected to reach USD 1.13 billion in 2025, at a CAGR 6.46% to reach USD 1.55 billion by 2030.

Aortic stent grafts play an indispensable role in the endovascular management of life-threatening aortic aneurysms. Endovascular aneurysm repair, commonly referred to as EVAR for abdominal aortic aneurysms and TEVAR for thoracic cases, has eclipsed open surgery as the predominant treatment modality, driven by minimally invasive techniques that reduce perioperative morbidity and mortality. In the United States alone, over 80,000 abdominal aortic aneurysm procedures were performed in 2021, with 81% managed via EVAR, underscoring the profound shift toward endovascular solutions that offer faster recovery and lower complication rates. These trends reflect a growing preference among vascular specialists for stent graft therapies that align with evolving standards of care and patient expectations.

Beyond abdominal aneurysms, the adoption of endovascular approaches has expanded into thoracic and thoracoabdominal aneurysm repair. Complex endovascular techniques, including fenestrated and branch-incorporating stent grafts, now address pathologies once reserved for open thoracoabdominal surgery. Clinical data from 2004 to 2019 demonstrate that the use of endovascular repair for intact thoracoabdominal aneurysms surged from 3.8% to 72%, with associated reductions in mortality following TEVAR procedures. This evolution reflects the maturation of device technology, improved operator experience, and robust post-market surveillance that continues to validate long-term outcomes.

Innovation in graft design and delivery platforms continues to accelerate, with more than 35 novel stent graft models introduced globally in 2023 alone. These next-generation systems incorporate advanced materials, such as bioresorbable frameworks and shape-memory alloys, as well as miniaturized delivery systems that reduce sheath diameters by up to 30%, broadening the candidate pool to include patients with small access vessels. Concurrently, the integration of sophisticated imaging modalities and three-dimensional planning tools enhances preoperative precision, enabling personalized device selection and placement. As these innovations coalesce, the landscape of aortic stent graft therapy is poised for continued transformation.

The aortic stent graft arena has witnessed a paradigm shift, propelled by the development of branch-and fenestrated graft architectures that adeptly preserve perfusion to vital aortic branches. Manufacturers have expanded their portfolios to include off-the-shelf branched endoprostheses designed for rapid deployment in emergent settings and custom fenestrated systems that accommodate complex anatomies. These advances enable clinicians to extend endovascular repair to a broader spectrum of thoracoabdominal pathologies previously deemed unsuitable for minimally invasive intervention.

Parallel to device evolution, digital technologies are redefining the continuum of care. The advent of three-dimensional printing and patient-specific modeling allows for bespoke stent graft prototypes that precisely conform to individual vascular geometries. These tools, coupled with artificial intelligence-driven sizing algorithms, streamline preoperative planning, reduce procedure times, and mitigate the risk of endoleaks and device migration. Industry leaders are now investing heavily in digital workflow solutions that integrate imaging data, surgical planning, and outcome tracking to deliver a cohesive clinical ecosystem.

Care delivery models are also transforming, with a notable shift of select endovascular repairs to outpatient settings. Recent evidence demonstrates that ambulatory EVAR can be performed safely in well-selected patients, yielding comparable complication rates and readmission frequencies to inpatient procedures while realizing a 27% reduction in 30-day costs and facilitating same-day discharge protocols. This transition underscores the drive toward lower-cost, high-value care pathways that align with evolving reimbursement incentives and patient preferences.

Pressures to optimize resource utilization and enhance clinical outcomes have spurred regulatory and professional bodies to refine guidelines. Institutions meeting Society for Vascular Surgery standards for EVAR now exceed 67% nationally, reflecting a commitment to quality and safety. However, concurrent declines in open repair competency highlight the need for careful balance in procedural volumes, mentorship, and regionalization strategies to sustain expertise in complex aortic surgery.

The resurgence of Section 301 tariffs on Class I and II medical devices has introduced significant headwinds for aortic stent graft supply chains. Reinstated in mid-2024, tariffs now range from 25% to 50% for devices and critical components sourced from China, compelling manufacturers to reassess cost structures and sourcing strategies. As the USTR expands its scope to include additional medical products, device makers confront heightened material costs, potential lead-time extensions, and increased logistical complexity that could ultimately translate into higher healthcare expenses.

Recognizing the essential nature of these interventions, the American Hospital Association has petitioned for exemptions on medical devices, arguing that tariffs on imported stent grafts and related supplies may jeopardize patient access and procedural availability. Letters submitted in February 2025 emphasize the risks of supply disruption for devices already constrained by production lead times and underscore the reliance of U.S. healthcare facilities on international manufacturing partnerships.

Independent analysis from GlobalData suggests that U.S. cardiovascular device companies may face revenue impacts of up to $80 million in 2025, driven by tariff-induced cost inflation and supply chain realignments. While some leading firms have absorbed initial tariff burdens, the absence of clear, long-term policy has prompted strategic shifts toward diversified sourcing and regional manufacturing hubs. Industry stakeholders warn that without stable tariff frameworks, frequent policy reversals will hinder capital investment decisions and complicate forecasting for supply continuity and pricing.

In response, manufacturers are accelerating efforts to localize production of key components and to secure exclusions for critical medical devices. Collaborative engagements with trade bodies and federal agencies aim to carve out specific tariff relief for life-saving graft systems. Meanwhile, supply chain leaders recommend multi-tiered strategies that blend near-shoring, alternate supplier qualification, and inventory buffering to safeguard against future tariff escalations and geopolitical disruptions.

The aortic stent graft market can be dissected through multiple lenses to reveal nuanced drivers and opportunities. Locations of aneurysm pathology span the abdominal segment, where both elective and emergency repairs predominate, through thoracic and thoracoabdominal zones, each of which demands distinct endovascular strategies calibrated to the region’s anatomical challenges. By parsing these categories, stakeholders can align device capabilities with patient risk profiles and procedural urgency.

Beyond anatomical considerations, graft designs are differentiated into branched systems suited for arch and visceral vessel preservation, fenestrated constructs that interface with target artery ostia, and standard grafts optimized for infrarenal aortic repair. Material choices further segment the market, pitting expanded polytetrafluoroethylene against polyester graft fabric, each offering discrete performance attributes in terms of flexibility, compliance, and long-term durability.

Configuration emerges as another critical dimension, with aorto-uni-iliac devices facilitating unilateral flow control, bifurcated grafts enabling bilateral iliac perfusion, and cuff extensions serving targeted vessel sealing. Deployment mechanics overlay these categories, contrasting balloon-expandable frameworks against self-expanding nitinol architectures, each influencing procedural complexity, radial force, and delivery sheath profiles.

Examining the route of delivery and care setting clarifies additional segmentation layers. Access pathways include transfemoral approaches that leverage common femoral vessels and iliac conduits that accommodate alternative insertion when standard entry points prove unsuitable. End-user distinctions separate hospitals equipped for complex hybrid interventions from ambulatory surgical centers that prioritize streamlined workflows for select endovascular cases.

In the Americas, the United States leads with a robust endovascular infrastructure supported by favorable reimbursement policies and high adoption of minimally invasive aortic interventions. More than 66,000 EVAR procedures were recorded in 2021, reflecting broad clinician proficiency and a network of specialized vascular centers. Concurrently, an uptick in ambulatory EVAR highlights a strategic shift toward outpatient models that reduce inpatient utilization and align with value-based care initiatives.

Europe, the Middle East, and Africa (EMEA) present a heterogeneous landscape driven by centralized regulatory pathways under the European Medical Device Regulation and region-specific health technology assessments. Nations such as Germany and France serve as early adopters of advanced branched and fenestrated grafts, whereas emerging markets in the Middle East and parts of Africa emphasize affordability and infrastructure development. Collaborative clinical registries and multicenter studies across EMEA support evidence generation, facilitating broader access to innovative endovascular solutions.

Asia-Pacific exhibits some of the fastest growth rates, propelled by demographic shifts and expanding cardiovascular disease burden. Japan’s aging population has driven the development of anatomically tailored grafts like Anaconda, while China’s regulatory agencies have recently accelerated approvals for next-generation thoracic and abdominal devices. Local manufacturing partnerships and investments in hybrid operating theater capacity underpin a strategic push to reduce reliance on imports and improve regional supply resilience.

Medtronic continues to command market leadership through its Endurant IIi system, which offers expanded neck sealing zones and enhanced conformability ideal for complex aneurysm anatomies. With global regulatory approvals spanning the U.S., Europe, and Asia, and a performance registry exceeding 10,000 patients, the platform exemplifies the integration of rigorous clinical evidence and broad distribution channels.

W. L. Gore & Associates distinguishes itself with proprietary expanded polytetrafluoroethylene grafts renowned for their biocompatibility and long-term durability. Its Gore Excluder and Conformable TAG systems leverage low-profile delivery and repositionable deployment to address challenging vessel anatomy. Gore’s direct sales approach emphasizes surgeon training and procedural support, fostering strong clinical partnerships and procedural efficiency improvements.

Cook Medical has solidified its presence in the fenestrated segment with the Zenith platform, which boasts a customizable, made-to-order manufacturing process that delivers patient-specific grafts in under eight weeks. Supported by over 60 patents and comprehensive clinical data demonstrating high branch vessel patency rates, Cook’s strategic focus on complex aortic pathologies is reinforced by rapid trial expansions and cross-continental production facilities.

Terumo Corporation leverages its cardiovascular heritage to deliver devices tailored for anatomies prevalent in Asia, such as the Anaconda AAA system designed for high angulation profiles. Recent CE mark clearances for the RelayBranch thoracic stent graft have expanded treatment options for aortic arch aneurysms, underscoring the company’s commitment to regional innovation and collaborative clinical partnerships.

Boston Scientific’s acquisition of Devoro Medical has integrated mechanochemical thrombectomy capabilities into its EVAR portfolio, addressing thrombus management within aneurysmal sacs. Early post-market data indicate a 40% reduction in secondary interventions when adjunctive thrombectomy is employed, illustrating Boston Scientific’s strategy to enhance procedural outcomes through complementary technology integration.

Foster supply chain resilience by diversifying sourcing strategies across multiple geographies and by pursuing exclusions or exemptions for critical graft components under Section 301 tariffs. Engaging proactively with trade authorities, optimizing inventory buffers, and near-shoring key manufacturing processes will reduce vulnerability to policy fluctuations and cost shocks.

Accelerate product innovation in branched and fenestrated graft systems, and integrate digital tools for preoperative planning and outcome monitoring. Investment in patient-specific modeling, AI-driven sizing algorithms, and hybrid operating theaters will enhance device fit, procedural precision, and long-term durability, differentiating offerings in an increasingly competitive market.

Expand ambulatory surgical center capabilities by establishing dedicated endovascular suites and streamlined pathways for low-risk EVAR patients. Demonstrating safety, cost savings, and patient satisfaction in outpatient settings will support negotiations with payers and position providers to capture shifts toward value-based care models.

Strengthen strategic partnerships with regional regulatory bodies and clinical centers of excellence to accelerate market access and evidence generation. Collaborative registries, investigator-initiated studies, and real‐world data capture will facilitate swift CE mark and PMA approvals while fostering clinician advocacy and best practice dissemination.

This analysis synthesizes insights derived through a rigorous mixed-methods approach. Primary research comprised in-depth interviews with vascular surgeons, procurement leaders, and regulatory experts to obtain qualitative perspectives on clinical needs and technology adoption.

Secondary research entailed comprehensive reviews of peer-reviewed literature, public regulatory filings, clinical trial registries, and corporate disclosures to validate device performance, market entry timelines, and product pipelines. Data from authoritative sources such as the Society for Vascular Surgery, global trade databases, and medical device regulatory agencies were triangulated to ensure accuracy and completeness.

Analytical frameworks included segmentation matrices, cross-regional comparisons, and competitive benchmarking. Market forces and policy impacts were evaluated through scenario modeling, while emerging trends were assessed via technology readiness and diffusion analyses. Findings were subjected to internal peer review by clinical and market research specialists to confirm methodological robustness and relevance to industry stakeholders.

Aortic stent graft technology has matured into a sophisticated domain where clinical innovation, digital integration, and strategic supply chain management converge. The ascendancy of EVAR and TEVAR underscores the value proposition of minimally invasive repair, yet it also elevates demands for device precision, durability, and evidence-based outcomes.

Emerging device designs, including branched and fenestrated grafts, alongside advanced materials and delivery systems, have expanded treatment indications and improved patient safety. However, external pressures such as tariffs and reimbursement shifts necessitate agile responses from all stakeholders to preserve market access and manage cost trajectories.

Segmentation analyses reveal distinct opportunities across anatomical categories, deployment configurations, and end-user settings, while regional insights highlight the interplay between regulatory regimes and local adoption patterns. Competitive intelligence underscores the criticality of differentiated innovation, robust clinical evidence, and strategic partnerships to maintain leadership and capture growth in dynamic markets.

Ultimately, a cohesive strategy that aligns product development, market access, and operational excellence will chart the next chapter of aortic stent graft evolution, driving better patient outcomes and sustainable business performance.

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