Peripheral arterial disease (PAD) affects more than 113 million people worldwide. By 2050, that figure is projected to reach 360 million. In the United States, an estimated 20 million adults are living with PAD, and roughly 150,000 of them lose a limb to it every year.

Those numbers are not the headline. The headline is what we still do not see when we treat them.

The argument is straightforward: in peripheral vascular, the imaging has not kept up with the intervention. The piece that follows is the data behind that argument. The disease is larger, more expensive, and more procedurally complex than it was a decade ago. The imaging operators rely on to plan and confirm the work has barely moved.

The Burden Has Doubled

Global PAD prevalence rose from roughly 56 million cases in 1990 to over 113 million by 2021, an increase of approximately 102%, even as age-standardized rates declined. A 2025 forecasting study published in Research, building on the Global Burden of Disease 2021 baseline, projects absolute case counts will rise to 360 million by 2050 (95% uncertainty interval: 270 to 450 million), driven by aging populations, diabetes, and the growing weight of metabolic risk factors in low- and middle-income countries.

In the United States, the cost picture is comparable to or larger than diabetes. The Society for Cardiovascular Angiography and Interventions (SCAI) estimates the annual economic burden of PAD at $233 to $414 billion in its policy analysis. The lifetime direct healthcare cost per amputee is approximately $640,849. Aggregated across the population of patients who lose a limb, that figure represents about $46.7 billion in lifetime cost.

Five-year mortality after a diagnosis of chronic limb-threatening ischemia (CLTI) exceeds 50%. One-year mortality is approximately 24%. These numbers rival or exceed those of many advanced cancers, and they have been stubborn for two decades.

The Procedure Has Evolved. The Imaging Has Not.

Over a million peripheral vascular interventions (PVIs) are performed annually in the United States. A Medicare analysis of more than 599,000 PVIs performed for claudication between 2011 and 2022 shows the workflow has shifted toward smaller, more distal anatomy. Tibial intervention rose from 13.2% of all PVIs in 2010 to 23.3% in 2022. Atherectomy use grew alongside it. Intravascular lithotripsy joined the toolkit, with the Disrupt PAD III trial showing roughly 80% lower rates of flow-limiting dissection in heavily calcified femoropopliteal lesions.

The tools have moved smaller and more sophisticated. The imaging operators rely on to guide them has not. Digital subtraction angiography is still the workhorse, and angiography is a lumenogram. It does not characterize plaque. It does not size vessels accurately, particularly in the heavily calcified or eccentric anatomy that defines below-the-knee disease.

The 2024 multispecialty expert consensus, signed by six US vascular and interventional societies (SCAI, the Society for Vascular Surgery, the Society of Interventional Radiology, the American Venous Forum, the American Vein and Lymphatic Society, and the Society for Vascular Medicine), stated this directly: angiography cannot reliably size vessels, characterize lesion morphology, or detect post-procedural complications.

The IVUS Evidence Is Real

Intravascular ultrasound (IVUS) is the catheter-based imaging technology that lets operators see inside the vessel wall during a procedure. Despite a randomized data base that is smaller than coronary IVUS, the peripheral evidence is consistent and growing.

A retrospective analysis of Centers for Medicare and Medicaid Services (CMS) data covering 543,488 lower extremity peripheral vascular interventions in Medicare beneficiaries between 2016 and 2019 (Divakaran et al., 2022) found that IVUS-guided procedures were associated with a 27% reduction in major adverse limb events (adjusted hazard ratio (HR) 0.73, 95% confidence interval 0.70 to 0.75). Within that composite, IVUS use was associated with a 31% reduction in major amputation (HR 0.69, 95% CI 0.66 to 0.71) and an 18% reduction in acute limb ischemia (HR 0.82, 95% CI 0.78 to 0.87).

A nationwide Japanese propensity-matched study of 85,649 patients undergoing peripheral endovascular therapy (EVT), of whom 50,925 received IVUS guidance, reported significantly lower 12-month amputation rates in the IVUS-guided arm (Setogawa et al., 2023). A prospective single-center Australian randomized trial of 150 patients with femoropopliteal disease (Allan et al., 2022) found that freedom from binary restenosis at 12 months was significantly higher with IVUS guidance (72.4% versus 55.4%, P = 0.008).

The 2024 American College of Cardiology / American Heart Association (ACC/AHA) multisociety PAD guideline and the 2024 multispecialty consensus both reinforce IVUS as appropriate adjunctive imaging across revascularization scenarios. The evidence is not perfect; most of it is observational. The direction is consistent across geographies, registries, and lesion levels.

The Adoption Paradox

The numbers on adoption are where the story gets uncomfortable.

Among 12,844 Medicare PVI operators studied between 2016 and 2019, mean IVUS use during PVI was 6.5%. Median use was 0%. Even among the operators who used IVUS at least once during the study period, median use was 5.4%. By location, IVUS was used in 4.0% of inpatient PVIs, 5.2% of outpatient PVIs, and 26.8% of procedures performed in office-based labs and ambulatory surgery centers (ASCs). Coronary IVUS adoption sits below 20% in the United States despite more than a dozen supportive randomized trials.

Three explanations come up consistently in the literature and in operator interviews.

The first is form factor. Current peripheral IVUS catheters were designed for the coronary tree and adapted afterwards. Distal tibial vessels can be a millimeter or less in diameter at the pedal arch, and a catheter built for the left anterior descending coronary artery (LAD) is bulky in that anatomy.

The second is what the imaging actually shows. IVUS is side-fire and rotational. It tells the operator what is already behind the catheter tip. Half the work below the knee is crossing a chronic total occlusion the operator cannot see past, and the imaging modality with the most clinical evidence does not address that question.

The third is workflow and economics. IVUS adds time and steps to a procedure already dense with wires, balloons, atherectomy devices, and lithotripsy systems. Cost-effectiveness data is incomplete; one CMS analysis showed a non-significant cost increase of approximately $1,334 per inpatient case (95% CI: −$167 to $2,833; P = 0.082). Cost remains one of the most commonly cited barriers to broader IVUS adoption in published surveys of practicing operators.

The result is a market in which the imaging modality with the strongest associative outcomes data is used in a single-digit percentage of procedures. The patients absorbing the consequences of that gap are the ones whose anatomy needs imaging the most.

What Has To Be True for Imaging to Match the Intervention

The peripheral lab needs three things from its next imaging platform.

It needs a form factor that fits the anatomy at every level the procedure now reaches, including the pedal arch. It needs forward visualization, because half of below-the-knee work involves crossing a lesion the operator cannot see past. And it needs to characterize the wall, not just the lumen, because plaque morphology, calcium pattern, and dissection extent determine the strategy and its confirmation.

For routine cases, a clean forward view of the wall and the plaque is enough to plan and confirm. For the harder cases, post-lithotripsy assessment, long below-the-knee disease, and dissection detection, multi-modality imaging on the same platform is what carries the case from adequate to definitive.

This is the brief the field has been articulating with increasing clarity. Closing it is the technical problem.

Where VerAvanti Fits

VerAvanti's Scanning Fiber Endoscope (SFE) is being developed as a forward-looking intravascular imaging platform built for the diameter constraints of peripheral and intravascular anatomy, with the architecture to combine real-time RGB color visualization and optical coherence tomography (OCT) on a single catheter. The platform is investigational. FDA 510(k) clearance, the regulatory pathway for medical devices in the United States, is anticipated later this year.

We will not make performance claims here. The data that matters will come from clinical study, not marketing copy.

What we can say is that the imaging gap quantified above is the gap the platform is being engineered to close, against the brief the field has set: pedal-arch sized, forward-looking, multi-modality. The numbers behind the disease are why that brief is urgent. The numbers behind the procedure are why it has to be met now.

The leg goes home with the patient when the imaging matches the intervention. Until that is true, a meaningful fraction of the 150,000 amputations the United States performs every year are the consequence of a planning and confirmation workflow that lags the rest of the field by a decade.

Closing the gap is the work.

References

1. GBD 2021 Diseases and Injuries Collaborators. Global incidence, prevalence, years lived with disability, disability-adjusted life-years, and healthy life expectancy for 371 diseases and injuries in 204 countries and territories, 1990 to 2021. The Lancet. 2024;403:2133-2161.

2. Yang Y, et al. Forecasting the Global Burden of Peripheral Artery Disease from 2021 to 2050: A Population-Based Study. Research (Science Partner Journal). 2025. doi:10.34133/research.0702.

3. Society for Cardiovascular Angiography and Interventions. Peripheral Artery Disease policy brief. SCAI government relations.

4. Gornik HL, Aronow HD, Goodney PP, et al. 2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/SIR/VESS Guideline for the Management of Lower Extremity Peripheral Artery Disease. Journal of the American College of Cardiology. 2024;83:2497-2604.

5. SCAI/AVF/AVLS/SIR/SVM/SVS Multidisciplinary Expert Opinion. Intravascular Ultrasound Use in Peripheral Arterial and Deep Venous Interventions. Journal of the Society for Cardiovascular Angiography and Interventions. January 2024.

6. Setogawa N, Ohbe H, Matsui H, Yasunaga H. Amputation After Endovascular Therapy With and Without Intravascular Ultrasound Guidance: A Nationwide Propensity Score-Matched Study. Circulation: Cardiovascular Interventions. 2023;16:e012451.

7. Dun C, Stonko DP, Bose S, Keegan AC, McDermott KM, et al. Trends and Factors Associated With Peripheral Vascular Interventions for the Treatment of Claudication From 2011 to 2022: A National Medicare Cohort Study. Journal of the American Heart Association. 2024;13:e033463.

8. Divakaran S, Parikh SA, Hawkins BM, Chen S, Song Y, Banerjee S, Rosenfield K, et al. Temporal Trends, Practice Variation, and Associated Outcomes With IVUS Use During Peripheral Arterial Intervention. JACC: Cardiovascular Interventions. 2022;15(20):2080-2090.

9. Tepe G, Brodmann M, Werner M, et al. Intravascular Lithotripsy for Peripheral Artery Calcification: 30-Day Outcomes From the Randomized Disrupt PAD III Trial. JACC: Cardiovascular Interventions. 2021;14(12):1352-1361.

10. Allan RB, Puckridge PJ, Spark JI, Delaney CL. The Impact of Intravascular Ultrasound on Femoropopliteal Artery Endovascular Interventions: A Randomized Controlled Trial. JACC: Cardiovascular Interventions. 2022;15(5):536-546.