The interventional cardiology community has reached an inflection point. For decades, angiography alone served as the primary guide for percutaneous coronary interventions (PCI). But as Dr. Eric A. Secemsky from Beth Israel Deaconess Medical Center recently noted, “We are better operators if we understand our limitations, and particularly our limitations with angiography alone when we aren’t using these tools.”[1]

A landmark study published in the January 2026 issue of JACC: Cardiovascular Interventions provides compelling evidence that the field is moving decisively beyond single-modality guidance. Analyzing 2,538,154 PCIs performed in 1,958,990 Medicare patients from 2016 to 2023—representing one of the largest examinations of adjunctive imaging in everyday clinical practice—researchers found that combining intravascular imaging (IVI) with invasive physiology (IP) delivers measurably superior outcomes in a cost-effective manner that benefits both patients and healthcare systems.[1]

The findings are striking: operators who used both imaging and physiology reduced major adverse cardiovascular events (MACE) by 13% (adjusted HR: 0.87, 95% CI: 0.85-0.89, P < 0.0001), all-cause death by 16% (adjusted HR: 0.84, 95% CI: 0.81-0.87, P < 0.0001), myocardial infarction by 14% (adjusted HR: 0.86, 95% CI: 0.82-0.90, P < 0.0001), and repeat revascularization by 12% (adjusted HR: 0.88, 95% CI: 0.85-0.91, P < 0.0001) compared to angiography alone.[1] Perhaps equally important, despite higher initial procedure costs, this dual-modality approach reduced long-term expenses through fewer complications, repeat procedures, and hospital readmissions.[1]

The Multi-Modal Revolution: From Theory to Practice

The data reveals a healthcare system in transition. Among the 1,587,532 patients included in the outcomes analysis (mean age 75.3 ± 7.0 years; 63.9% men; 87.8% white), intravascular imaging was used in approximately 15% of all PCIs, IP in 7%, and dual IVI and IP in 2.5%.[1]

Between 2016 and 2023, the transformation was dramatic:

• IVUS adoption surged from 7.7% to 29.6%—a nearly fourfold increase[1]

• OCT use grew from 0.13% to 0.32%[1]

• Combined imaging plus physiology increased from 1.0% to 4.7%[1]

• IP use in diagnostic angiography rose from 5.9% to 7.4% (P = 0.0021)[1]

This growth didn’t happen in a vacuum. It reflects accumulating clinical evidence, evolving practice guidelines, and a fundamental recognition among interventional cardiologists that different imaging modalities provide complementary information essential for optimal patient outcomes.

Why Operators Are Embracing Multi-Modal Guidance

The rationale is straightforward: each imaging modality answers different critical questions during PCI.

Invasive physiology (fractional flow reserve/FFR and instantaneous wave-free ratio/iFR) helps operators determine whether a lesion is hemodynamically significant enough to warrant intervention. This reduces unnecessary procedures and focuses treatment on stenoses that truly compromise blood flow.

Intravascular imaging (primarily intravascular ultrasound/IVUS at 98.4% of imaging cases, and optical coherence tomography/OCT at 1.6%)[1] provides detailed visualization of vessel architecture, plaque characteristics, and stent deployment quality. This enables operators to optimize stent sizing, ensure complete expansion, and verify adequate wall apposition—factors directly linked to long-term success.

The combination addresses what angiography alone cannot: functional significance plus structural detail. As lead author Frank A. Medina explained, this dual approach enables “optimizing lesion selection” so treatment targets the most severe cases while avoiding unnecessary interventions.[1]

The Clinical Evidence: Real-World Outcomes at Massive Scale

The Medicare study’s strength lies in its unprecedented scope and real-world applicability. Among the overall study population, 53.6% underwent their index PCI as inpatients, and 60.6% presented with acute coronary syndromes (of which 24.5% were ST-segment elevation MI).[1]

The outcomes data speaks for itself across every measured endpoint:

Two-Year MACE Reduction vs. Angiography Alone:[1]

• Intravascular imaging alone: 6% reduction (adjusted HR: 0.94, 95% CI: 0.93-0.95, P < 0.0001)

• Invasive physiology alone: 15% reduction (adjusted HR: 0.85, 95% CI: 0.84-0.86, P < 0.0001)

• Both modalities combined: 13% reduction (adjusted HR: 0.87, 95% CI: 0.85-0.89, P < 0.0001)

Additional Two-Year Outcomes for Combined Modalities:[1]

• All-cause death: 16% reduction (adjusted HR: 0.84, 95% CI: 0.81-0.87, P < 0.0001)

• Myocardial infarction: 14% reduction (adjusted HR: 0.86, 95% CI: 0.82-0.90, P < 0.0001)

• Repeat revascularization: 12% reduction (adjusted HR: 0.88, 95% CI: 0.85-0.91, P < 0.0001)

• Stroke/TIA: No significant difference (adjusted HR: 0.96, 95% CI: 0.88-1.03, P = 0.2559)

What makes these findings particularly compelling is their consistency across outcome measures and their validation through falsification endpoints. When researchers examined gastrointestinal bleeding and hip fracture as negative controls to assess for residual confounding, dual IVI and IP showed no significant difference (GI bleeding HR: 1.01, 95% CI: 0.97-1.06, P = 0.5933; hip fracture HR: 0.95, 95% CI: 0.86-1.05, P = 0.2963).[1] This suggests the observed cardiovascular benefits are real, not artifacts of selection bias.

The breadth of benefit—extending to mortality, myocardial infarction, and repeat revascularization—suggests that multi-modal guidance improves the fundamental quality of PCI procedures across multiple dimensions.

The Cost-Effectiveness Equation

Healthcare systems increasingly demand evidence not just of clinical benefit, but of economic value. The Medicare study addresses this head-on with a detailed cost analysis of 736,510 patients (46.5% of the study population) who underwent outpatient PCI.[1]

Index Procedure Costs:[1] While initial charges were higher for imaging-guided PCI (IVI: $3,342.70; IP: $3,108.00; dual: $3,640.30; none: $3,254.40; P < 0.001), and provider payments were higher across all three categories of adjunctive assessment (IVI: $837.00; IP: $801.10; dual: $892.20; none: $679.80; P < 0.001), the two-year total costs told a different story.

Two-Year Follow-Up Costs:[1] Patients who initially underwent PCI guided by IVI and/or IP had significantly lower average charges related to:

• Repeat revascularizations: IVI: $732.60; IP: $568.20; dual: $576.90; none: $1,006.40 (P < 0.001)

• Hospital readmissions: IVI: $90,843.40; IP: $75,180.70; dual: $78,341.20; none: $99,767.90 (P < 0.001)

Adjusted Cost Ratios:[1] After adjustment for patient and hospital characteristics, dual IVI and IP showed:

• 22% higher index procedure charges (cost ratio: 1.22, 95% CI: 1.20-1.23, P < 0.0001)

• 35% higher index provider payments (cost ratio: 1.35, 95% CI: 1.34-1.35, P < 0.0001)

• 30% lower repeat revascularization charges (cost ratio: 0.70, 95% CI: 0.68-0.73, P < 0.0001)

• 21% lower repeat revascularization payments (cost ratio: 0.79, 95% CI: 0.77-0.82, P < 0.0001)

• 15% lower readmission charges (cost ratio: 0.85, 95% CI: 0.82-0.89, P < 0.0001)

• 12% lower readmission payments (cost ratio: 0.88, 95% CI: 0.85-0.91, P < 0.0001)

This finding has profound implications for hospital administrators, payers, and policymakers. As Dr. Secemsky noted, “If we can do this in a cost-conscious way, I think that we can make a good case that this should be standard practice.”[1]

The reimbursement landscape appears to be shifting in response. As noted by Medina, intravascular imaging has been on the upswing thanks to its endorsement in the 2018 European and 2021 US revascularization guidelines.[1] As of 2024 and 2025, European and US guidelines gave intravascular imaging a Class 1a indication for guiding PCI in chronic and acute coronary syndromes, respectively.[1]

This guideline support, combined with mounting clinical evidence and demonstrated cost-effectiveness, suggests an increasingly favorable environment for advanced imaging technologies.

The Technology Landscape: Integration is the Future

Perhaps the most forward-looking insight from the JACC study comes from the accompanying editorial by Drs. Edward T. Ha, Tatsunori Takahashi, and Yuhei Kobayashi. They specifically highlight that “truly integrated platforms” combining intravascular imaging and physiological assessment are likely to “streamline cardiac catheterization laboratory flow and achieve cost-effectiveness.”[1]

This observation reflects a broader trend in medical device innovation: moving from discrete tools that require separate catheter exchanges and workflow steps toward integrated platforms that provide comprehensive information more efficiently.

The editorialists identify several key advantages when these integrated multi-modal systems are used to guide PCI:[1]

1. Improved lesion selection by considering both physiological significance and plaque vulnerability

2. Better treatment of diffuse and tandem lesions where multiple areas of disease require careful assessment

3. Post-procedural optimization to ensure optimal stent deployment and vessel outcomes

They conclude emphatically: “It is imperative that we advocate for and implement these innovations to ensure the provision of precise, secure, and efficacious patient care.”[1]

The Critical Gap: What Current Imaging Still Cannot See

Despite these advances, current imaging modalities share a fundamental limitation: they predominantly provide side-looking or cross-sectional views of the vessel at the catheter’s current position. Both IVUS (which accounted for 98.4% of imaging cases)[1] and OCT (1.6% of imaging cases)[1] excel at visualizing vessel walls, measuring dimensions, and characterizing plaque—but only where the catheter currently sits.

This limitation becomes critically apparent in the most challenging coronary cases: chronic total occlusions (CTOs). These complete blockages represent some of the most technically demanding procedures in interventional cardiology, yet the Medicare study revealed a striking pattern: CTO was a NEGATIVE predictor for dual imaging and physiology use (adjusted OR: 0.68, 95% CI: 0.64-0.71).[1]

This finding is remarkable. In bifurcation lesions, multivessel disease, and procedures requiring calcium modification—all complex scenarios—imaging adoption INCREASED. But in CTOs, despite their complexity, operators were LESS likely to use advanced imaging. This isn’t operator preference or guideline non-compliance. It’s recognition that current imaging—while excellent for many applications—fundamentally cannot address the primary CTO challenge: navigating through the occlusion to reach the distal vessel.

Current intravascular imaging modalities can visualize the vessel where they are positioned, but cannot see ahead through the occlusion to identify the distal true lumen, determine the occlusion length, or assess the vessel architecture beyond the blockage. Operators must advance guidewires and catheters through CTOs using indirect clues, fluoroscopic landmarks, and educated guesses about the path ahead.

This is the critical gap in the multi-modal imaging revolution: the inability to see ahead.

Enter Scanning Fiber Endoscope (SFE) Technology: Forward-Looking Vision

VerAvanti’s Scanning Fiber Endoscope technology addresses this fundamental limitation by providing what no other intravascular imaging modality can: true forward-looking visualization.

How SFE Works

SFE technology uses an ultrafast scanning optical fiber to create real-time video images of the vessel ahead of the catheter tip. Unlike side-looking IVUS or OCT, which image the vessel walls perpendicular to the catheter, SFE projects forward—allowing operators to see what lies ahead before advancing their devices.

The technical innovation centers on a miniaturized scanning fiber system that can fit within catheter dimensions suitable for coronary intervention. The system delivers:

• Real-time forward-looking video at frame rates sufficient for procedural guidance

• Depth perception that helps operators distinguish true lumen from false passages

• Integration potential with complementary imaging modalities

The SFE Advantage: Seeing What Others Cannot

The implications for CTO intervention are profound. With forward-looking SFE visualization, operators can:

1. Identify the distal true lumen through the occlusion, dramatically improving guidewire crossing success rates

2. Detect subintimal entry early, before extensive dissection occurs, allowing prompt redirection

3. Assess occlusion length and architecture to inform procedural strategy

4. Navigate complex anatomy including bifurcations and calcified segments with greater confidence

5. Reduce procedure times, radiation exposure, and contrast volumes by eliminating much of the trial-and-error inherent in current CTO techniques

For CTO patients currently facing limited treatment options, SFE represents a potential path to successful revascularization. For the procedures that currently succeed, SFE promises higher success rates, fewer complications, and more efficient procedures.

SFE in the Context of Multi-Modal Guidance: The Perfect Complement

The Medicare study’s validation of dual-modality imaging doesn’t just support current technologies—it provides the perfect framework for understanding SFE’s value proposition.

Complementary, Not Competitive

SFE doesn’t replace IVUS, OCT, or physiological assessment. Rather, it adds a critical missing dimension: forward visualization. The study data actually validates this positioning.

Current imaging excels at:[1]

• Complex lesion assessment (bifurcations, left main, in-stent restenosis)

• Stent optimization

• Calcium-modifying procedures (used with atherectomy and lithotripsy)

Current imaging struggles with:[1]

• Chronic total occlusions (negative predictor for dual use)

• Cases requiring navigation through unknown territory

Consider the ideal multi-modal approach to a complex CTO case using the paradigm established by the Medicare study:

1. Physiological assessment determines whether the occluded vessel territory has viable myocardium worth revascularizing

2. Forward-looking SFE guides the operator through the occlusion to the distal true lumen

3. Cross-sectional imaging (IVUS or OCT) optimizes vessel preparation and stent deployment

4. Post-procedural imaging and physiology confirm optimal results

Each modality contributes unique information. The combination addresses what editorialists Ha, Takahashi, and Kobayashi called for: truly integrated platforms that enable “precise, secure, and efficacious patient care.”[1]

The Hybrid SFE Future

VerAvanti’s technical roadmap recognizes this complementary relationship. Development efforts toward hybrid SFE+OCT systems would combine forward-looking visualization with high-resolution cross-sectional imaging in a single platform—precisely the kind of integration the field is moving toward.

Such a system would provide:

• Forward visualization to navigate through occlusions and complex anatomy

• Cross-sectional imaging for vessel sizing and stent optimization

• Streamlined workflow with a single catheter platform

• Comprehensive procedural guidance from lesion crossing through final optimization

This represents the natural evolution of the multi-modal paradigm: not just using multiple modalities, but integrating them intelligently to provide operators with comprehensive real-time information.

The CTO Evidence Gap: What the Medicare Study Reveals About Current Imaging’s Limitations

While the Medicare study demonstrates compelling benefits for multi-modal imaging across PCI generally, a closer examination of the data reveals a critical and telling pattern specific to chronic total occlusions—one that validates VerAvanti’s strategic focus and highlights an important unmet need.

The CTO Paradox: Imaging Use DECREASES Where Complexity is HIGHEST

The study’s multivariable analysis revealed something striking: chronic total occlusion was a NEGATIVE predictor for dual imaging and physiology use (adjusted OR: 0.68, 95% CI: 0.64-0.71).[1]

This finding deserves careful examination. In multivessel disease, bifurcation lesions, and left main procedures—all complex scenarios—dual modality use INCREASED. But in CTOs, despite being among the most challenging cases in interventional cardiology, operators were LESS likely to use advanced imaging.

The study authors documented this pattern in their predictors analysis:[1]

Positive predictors for dual IVI and IP use included:

• In-stent restenosis (OR: 1.30)

• Bifurcation lesions (OR: 1.24)

• Multivessel disease (OR: 1.12)

• Atherectomy (OR: 1.59)

• Coronary lithotripsy (OR: 3.03)

Negative predictors for dual IVI and IP use included:

• Chronic total occlusion (OR: 0.68)

• Acute MI unspecified (OR: 0.48)

• STEMI (OR: 0.31)

• Cardiogenic shock (OR: 0.54)

• Use of mechanical circulatory support (OR: 0.70-0.72)

What the Imaging Utilization Data Shows

The study documented specific patterns of imaging use:[1]

Overall IVI use in the study:

• IVI was used in 15.1% of all PCIs (98.4% IVUS, 1.6% OCT)

• Among IVI-guided cases, 7.8% involved CTOs

• IVI was most frequently used in left main (11.3%) and left anterior descending arteries (51.7%)

Dual modality use patterns:

• Used in 2.5% of all PCIs overall

• Increased from 1.0% (2016) to 4.7% (2023)

• More common in outpatient settings, academic centers, and larger hospitals

• CTO was a significant negative predictor in multivariable analysis

Comparative imaging use by lesion type:

• Bifurcation lesions: 6.8% of IVI cases[1]

• Left main: 11.3% of IVI cases[1]

• CTO: 7.8% of IVI cases[1]

Despite CTOs being recognized as among the most complex lesion types in interventional cardiology, imaging use was not elevated compared to other complex anatomies.

Understanding the Clinical Context

The study authors provide important context about when and why operators choose different imaging modalities. In their discussion, they note:[1]

“IVI and IP serve different purposes, but each has an important and complementary role for improving PCI. Although IP is not widely used for intraprocedural and postprocedural assessments, an expanding role for a combined approach using both IVI and IP has been described in specialized techniques such as ultra-low-contrast PCI and in post-PCI assessments of complex disease.”

However, the data shows that in CTO cases specifically, this complementary approach is used LESS frequently, not more—despite CTOs clearly qualifying as “complex disease.”

The Anatomical Imaging Challenge in CTOs

While the study doesn’t specifically analyze why CTO is a negative predictor, the fundamental difference between CTOs and other lesion types lies in the procedural challenge they present:

What IVUS and OCT Provide:

• Cross-sectional vessel imaging at the catheter location

• Excellent visualization of vessel wall, plaque characteristics

• Superior for stent sizing, optimization, and complication detection

• Validated for bifurcations, left main, in-stent restenosis (all positive predictors in the study)[1]

The CTO-Specific Challenge:

• Current imaging modalities image perpendicular to (IVUS) or at (OCT) the catheter position

• Cannot visualize ahead through an occlusion to identify the distal true lumen

• Limited utility during the crossing phase of CTO intervention

• Most useful AFTER successful crossing for vessel preparation and stent optimization

The Procedural Reality:

In bifurcations, left main, and in-stent restenosis—all positive predictors for imaging use[1]—operators can position the imaging catheter at the lesion and obtain clinically useful information to guide their intervention.

In CTOs, the primary challenge is navigating through the occlusion to reach the distal vessel. During this critical crossing phase, current imaging technologies positioned proximal to or within the occlusion cannot visualize the path ahead or identify the distal true lumen.

This fundamental limitation may explain why the study found CTO to be a negative predictor for imaging use—operators recognize that current imaging modalities, while excellent for many applications, do not address the specific challenge that makes CTO procedures technically difficult.

The Clinical Outcomes in Perspective

The study demonstrated impressive MACE reductions with dual modality imaging:[1]

Two-Year Outcomes vs. Angiography Alone:

• MACE: 13% reduction (HR: 0.87, 95% CI: 0.85-0.89)

• All-cause death: 16% reduction (HR: 0.84, 95% CI: 0.81-0.87)

• MI: 14% reduction (HR: 0.86, 95% CI: 0.82-0.90)

• Repeat revascularization: 12% reduction (HR: 0.88, 95% CI: 0.85-0.91)

These benefits were realized across all PCI cases, including the subset involving CTOs. However, the study’s administrative claims data could not determine:[1]

“Whether repeat PCI was performed to the same index lesion or a separate de novo lesion.”

This limitation is particularly relevant for CTOs, where:

• Initial crossing attempts may be unsuccessful

• Staged procedures may be planned

• Repeat attempts may be needed with different techniques or equipment

The true impact of imaging on CTO-specific outcomes—particularly technical success rates, first-pass crossing success, and need for repeat procedures—requires dedicated CTO studies that the Medicare claims analysis could not provide.

The Economic Implications for CTOs

The Medicare study’s cost analysis provides important context:[1]

For dual modality approaches overall:

• 35% higher index procedure provider payments ($892.20 vs. $679.80 for angiography alone)

• 21% lower repeat revascularization payments at 2 years (cost ratio: 0.79, 95% CI: 0.77-0.82)

• 12% lower hospital readmission payments at 2 years (cost ratio: 0.88, 95% CI: 0.85-0.91)

• Net result: Higher upfront costs justified by long-term savings

The study specifically notes regarding costs:[1] “Both intravascular imaging and dual use, but not invasive physiology, had higher index PCI costs compared with angiography, while provider payments were higher across all three categories of adjunctive assessment. Then, 2 years after PCI, those who had intravascular imaging and/or invasive physiology had lower average costs related to repeat revascularization and hospital readmissions.”

The CTO Cost Context:

CTO procedures are typically longer and more resource-intensive than non-occlusive lesions:

• Extended procedure times

• Higher contrast volumes

• Greater fluoroscopy exposure

• Multiple guidewires and specialty equipment

• Potential for complications requiring intervention

When initial crossing attempts are unsuccessful, these costs are incurred without achieving the intended revascularization. Repeat or staged procedures multiply these costs.

The study’s framework showing that higher upfront imaging costs can be justified by reduced long-term costs[1] is particularly relevant for CTOs, where:

• Improving first-pass success rates would eliminate need for staged procedures

• Reducing complications would decrease acute care costs

• Achieving complete revascularization would reduce ischemia-driven events

The Guideline Context and the CTO Gap

The study provides important context about guideline evolution:[1]

“As of 2024 and 2025, European and US guidelines gave intravascular imaging a class 1a indication for guiding PCI in chronic and acute coronary syndromes, respectively.”

The authors note:[1] “Influenced by this, the European Society of Cardiology and American College of Cardiology/American Heart Association have recently assigned IVI a Class 1a recommendation for anatomically complex lesions—in particular left main, bifurcations, and long lesions—during PCI for chronic and acute coronary syndromes, respectively.”

The CTO Guideline Gap:

CTOs clearly fit the definition of “anatomically complex lesions,” yet the study data shows imaging use is LOWER in CTOs (negative predictor with OR: 0.68)[1] compared to other complex lesion types that are positive predictors.

This creates an apparent disconnect:

• Guidelines recommend: Class 1a imaging for complex lesions[1]

• CTOs qualify: Among the most complex lesion types

• Operators use imaging less: CTO is negative predictor (OR: 0.68)[1]

This pattern suggests that current imaging technologies, while valuable for the complex lesions where they show positive predictor status, may not address the specific procedural challenges that define CTO complexity.

Regional and Institutional Patterns: Where CTO Programs Align with Imaging Adoption

The study documented specific patterns of where dual modality imaging is most commonly adopted:[1]

Highest dual modality use:

• Western and northeastern US regions

• Urban areas

• Academic medical centers

• Larger hospitals (≥500 beds)

• Communities with higher economic well-being

The strategic alignment:

These institutional characteristics closely align with where dedicated CTO programs are typically established. High-volume CTO programs generally require:

• Significant procedural volumes to maintain operator expertise

• Specialized equipment and imaging capabilities

• Advanced catheterization laboratory infrastructure

• Academic or research orientation for quality improvement

• Financial resources to support program development

The Medicare study’s finding that these same institutions show highest adoption of advanced imaging technologies[1] suggests that:

1. Culture of innovation exists: Institutions investing in dual modality imaging are also investing in complex PCI capabilities

2. Economic resources available: Willingness to adopt 35% cost premium technologies[1] indicates capacity for innovation investment

3. Quality focus: Academic centers tracking outcomes are ideal early adopters for new technologies

4. Target market concentration: CTO programs are concentrated at facilities already demonstrating advanced imaging adoption

Operator Selection Patterns: What Drives Imaging Adoption

The study’s positive and negative predictors reveal how operators make decisions about imaging use:[1]

Positive predictors (operators actively choose imaging):

• Bifurcation lesions (OR: 1.24)

• In-stent restenosis (OR: 1.30)

• Calcium modification with lithotripsy (OR: 3.03)

• Atherectomy use (OR: 1.59)

Negative predictors (operators avoid imaging):

• CTO (OR: 0.68)

• Acute MI with cardiogenic shock (OR: 0.54)

• Mechanical circulatory support use (OR: 0.70-0.72)

The pattern that emerges:

Operators enthusiastically adopt imaging when it directly addresses their procedural challenge:

• Bifurcations: Cross-sectional imaging identifies side branch compromise, guides ostial stent placement

• In-stent restenosis: Cross-sectional imaging determines mechanism (underexpansion vs. neointimal hyperplasia)

• Calcium modification: Cross-sectional imaging guides ablation depth, verifies results

Operators use imaging less when:

• Time is critical (shock, hemodynamic instability)

• Other priorities dominate (mechanical support, rapid reperfusion)

• Imaging doesn’t address the primary challenge (CTO crossing)

The CTO Implication:

The negative predictor status for CTOs (OR: 0.68)[1] suggests that operators have determined through experience that current imaging—while valuable in many contexts—does not address the fundamental challenge that makes CTO procedures difficult: navigating through the occlusion to the distal true lumen.

This is not a rejection of imaging’s value. Rather, it’s selective use based on procedural utility—the same selection logic that drives POSITIVE adoption in bifurcations and in-stent restenosis.

The Technology Gap: What Current Imaging Cannot Provide

The study demonstrates that the interventional cardiology field has embraced advanced imaging when it provides actionable information:[1]

Where current imaging excels (positive predictors):[1]

• Bifurcation anatomy: Visualize side branch ostium, measure angles, assess plaque distribution

• Stent optimization: Measure expansion, identify malapposition, detect edge dissection

• Calcium assessment: Quantify calcium arc and thickness to guide modification strategy

• Plaque characterization: Differentiate lipidic from calcific plaque

Where current imaging has limitations:

• Forward visualization: Cannot see ahead of the catheter tip

• Through-occlusion imaging: Cannot visualize distal vessel through a CTO

• Real-time navigation: Cannot guide guidewire toward distal true lumen

• Subintimal space detection: Cannot prospectively identify when entering false lumen

The CTO Procedural Challenge:

CTO intervention typically involves:

1. Crossing the occlusion: Navigate through fibrotic/calcified tissue to distal vessel

2. Finding true lumen: Identify distal vessel pathway avoiding subintimal space

3. Vessel preparation: After successful crossing, prepare vessel for stenting

4. Stent optimization: Deploy and optimize stent

Current imaging helps with steps 3 and 4 (vessel preparation and stent optimization)—the same capabilities that make it valuable in bifurcations and in-stent restenosis.

Current imaging cannot help with steps 1 and 2 (crossing and finding true lumen)—the unique challenges that define CTO complexity.

This fundamental limitation may explain the negative predictor status in the Medicare study.[1] Operators use imaging where it provides procedural value. In CTOs, current imaging’s value is limited to the post-crossing phases—but these phases are only reached if crossing succeeds.

SFE’s Role: Addressing What the Medicare Study Revealed

The Medicare study’s findings create the perfect context for understanding SFE’s value proposition in CTOs:

What the study conclusively demonstrates:[1]

1. Imaging adoption is accelerating: Nearly fourfold increase from 2016-2023

2. Dual modality delivers clinical benefit: 13% MACE reduction, 16% mortality reduction, 14% MI reduction

3. Cost-effectiveness is proven: 21% lower revascularization costs, 12% lower readmission costs despite 35% higher upfront costs

4. Guideline support exists: Class 1a for complex lesions

5. Operators adopt imaging selectively: Positive predictors align with imaging capabilities

6. Current imaging has limitations in CTOs: Negative predictor status (OR: 0.68)

What this pattern suggests for SFE:

If imaging technology could address the specific procedural challenge that makes CTOs difficult (navigating to the distal true lumen), the adoption pattern could potentially shift. The study shows operators actively embrace imaging when it solves their procedural challenge—bifurcations (OR: 1.24), calcium modification (OR: 3.03).[1]

SFE’s forward-looking capability could potentially:

• Address the crossing challenge where current imaging cannot help

• Enable real-time navigation toward distal true lumen

• Detect subintimal entry before extensive dissection

• Reduce trial-and-error guidewire manipulation

• Improve procedural efficiency and success rates. If SFE demonstrates these capabilities, it would align with the pattern the Medicare study reveals: operators adopt imaging that solves specific procedural challenges.[1]

The Market Opportunity Context

The Medicare study quantifies the CTO opportunity:[1]

Total scope:

• 2,538,154 PCIs performed from 2016-2023 in Medicare FFS population

• Average of ~324,000 PCIs annually in the Medicare FFS population alone.

CTO procedures in the study:[1]

• 17,985 IVI-guided cases involved CTOs (7.8% of IVI cases)

• 5,489 IP-guided cases involved CTOs (4.8% of IP cases)

• 1,884 dual modality cases involved CTOs (4.8% of dual cases)

• 79,806 angiography-only cases involved CTOs (6.6% of angio-only cases)

• Total CTO cases: 105,164 over 7 years (~15,000 annually in Medicare FFS)

Market extrapolation:

Medicare FFS represents approximately 30-40% of total PCI procedures in the US, suggesting:

• ~40,000-50,000 CTO procedures annually across all payers in the US

• Substantial unmet need given negative predictor status for current imaging

• Established reimbursement for imaging in complex PCI (35% premium accepted)[1]

• Growing market with 2.6% annual increase in imaging adoption[1]

The Evidence SFE Must Generate

The Medicare study provides a rigorous methodological framework for evaluating imaging technologies:[1]

Study design elements to adopt:

• Primary endpoint: MACE composite (MI, repeat revascularization, all-cause death) at 2 years

• Secondary endpoints: Individual MACE components

• Safety assessment: Falsification endpoints (GI bleeding, hip fracture) to assess confounding

• Cost analysis: Index procedure costs, repeat revascularization costs, readmission costs at 2 years

• Statistical approach: Multivariable Cox regression accounting for patient, procedural, and hospital factors

For CTO-specific imaging technology, additional endpoints would include:

• Technical success: Achievement of guidewire crossing with restoration of antegrade flow

• Procedural efficiency: Procedure time, fluoroscopy time, contrast volume

• Crossing efficiency: Time to crossing, number of attempts

• Complication rates: Perforation, dissection, stroke

• Resource utilization: Device usage, staged procedures

Market Timing: The Perfect Storm for SFE Adoption

Multiple factors converge to create optimal market conditions for SFE’s introduction as VerAvanti approaches FDA 510(k) submission. The Medicare study provides compelling evidence across every dimension relevant to market readiness.

1. Clinical Momentum: Adoption Accelerating

The nearly fourfold increase in intravascular imaging use (from 7.7% to 29.6%) from 2016 to 2023[1] reflects a field that has moved past the question of “whether” to embrace advanced imaging. The field is now asking “how” to do so most effectively.

More telling: the rate of increase is accelerating. IVUS use showed an average 2.6% annual growth rate (P = 0.0003), while dual IVI and IP showed 0.5% annual growth (P < 0.0001).[1] This momentum suggests operators are actively seeking better visualization tools.

CTO intervention, in particular, has seen growing interest with dedicated CTO programs expanding at major medical centers. The study shows 7.8% of IVI-guided cases involved CTOs,[1] yet CTO was a negative predictor for dual modality use—highlighting the unmet need for imaging that can actually help with these challenging cases.

2. Guideline Support: Class 1a Endorsement Creates Institutional Imperative

The elevation of imaging-guided PCI to Class 1a recommendation status in both European (2024) and US (2025) guidelines provides institutional endorsement that facilitates adoption.[1] While these recommendations currently reference IVUS and OCT, they establish the principle that advanced imaging should be standard of care—creating a favorable environment for new imaging modalities with complementary capabilities.

The guidelines specifically highlight:[1]

• Complex lesions (left main, bifurcations, long lesions)

• Anatomically challenging cases

• Optimization of procedural results

CTOs fit squarely within this “complex lesion” category where guidelines now mandate imaging guidance—yet current imaging cannot address the fundamental challenge of crossing the occlusion. This creates the perfect regulatory and clinical positioning for SFE.

3. Economic Alignment: Value-Based Care Validation

The Medicare study’s cost analysis provides a validated roadmap for SFE’s value proposition:[1]

For dual modality approaches:

• 35% higher initial costs accepted by market

• 21% lower repeat revascularization costs at 2 years

• 12% lower readmission costs at 2 years

• Net positive value over 2-year timeframe

For CTO cases specifically, the economic argument may be even more compelling. The study’s

framework showing that higher upfront imaging costs can be justified by reduced long-term costs[1] is particularly relevant for CTOs, where improving first-pass success rates would:

• Eliminate need for staged procedures

• Reduce complications requiring emergency intervention

• Decrease total procedure time and resource utilization

• Reduce patient contrast and radiation exposure

• Achieve complete revascularization, reducing ischemia-driven events

4. Procedural Setting: Outpatient Opportunity

The study revealed that dual modality use was more common in the outpatient setting,[1] while imaging alone was used more in inpatient cases. This is significant because:

• Elective CTO programs typically schedule complex cases as outpatient procedures at high-volume centers

• Outpatient procedures have clearer cost accounting (the study limited cost analysis to outpatient cases for this reason)[1]

• Value-based contracting is easier to demonstrate in the outpatient setting

5. Regional and Institutional Patterns: Clear Target Markets

The study identified specific adoption patterns that inform SFE’s commercial strategy:[1]

Highest dual modality adoption:

• Western and northeastern US regions

• Urban areas with larger medical centers

• Academic medical centers and teaching hospitals

• Larger hospitals (≥500 beds)

• Communities with higher economic well-being

Translation for VerAvanti: Focus initial commercialization on academic medical centers in Western states (particularly California, where interventional cardiology innovation clusters exist) and Northeastern metropolitan areas. These institutions have demonstrated willingness to adopt advanced imaging and have the procedural volume to justify capital investment.

6. The Integration Trend: First-Mover Advantage

The editorial’s emphasis on “truly integrated platforms”[1] validates VerAvanti’s strategic direction—but also highlights urgency. As the field moves toward multi-modal systems, being first to market with forward-looking capability integrated into comprehensive imaging platforms provides significant competitive advantage.

The study notes that “technological advancements in the cath lab are moving in the same direction with devices that by design integrate both intravascular imaging and physiological assessment.”[1] VerAvanti’s hybrid SFE+OCT development positions the company to lead this integration trend by adding the forward-looking dimension that current integrated platforms lack.

Conclusion: The Convergence of Need, Technology, and Timing

The Medicare study’s validation of multi-modal imaging guidance represents far more than an academic exercise. Analyzing 2,538,154 PCIs in 1,958,990 patients over 7 years,[1] it demonstrates that the interventional cardiology field has decisively embraced the principle that better visualization drives better outcomes—with 13% MACE reduction, 16% mortality reduction, and 14% MI reduction when using dual modality approaches[1]—and is willing to invest in technologies that provide complementary information.

For VerAvanti, this creates an extraordinary opportunity. The study reveals a critical gap: while imaging adoption has surged nearly fourfold,[1] chronic total occlusions show a negative predictor status (OR: 0.68)[1] for current imaging use. This isn’t operator reluctance to embrace imaging—the same operators enthusiastically adopt imaging for bifurcations (OR: 1.24) and calcium modification (OR: 3.03).[1] It’s recognition that current imaging modalities, while excellent for many applications, do not address the fundamental challenge that makes CTO procedures difficult: navigating through the occlusion to the distal vessel.

As Dr. Secemsky noted, “We are better operators if we understand our limitations.”[1] The limitation of current imaging—demonstrated by its reduced adoption in CTOs despite these being complex lesions qualifying for Class 1a imaging recommendations[1]—is the fundamental inability to see ahead.

The study provides multiple powerful validation points for SFE:

1. Clinical validation: Imaging reduces MACE by 6-15% depending on modality[1]

2. Economic validation: 35% higher upfront costs justified by 21-30% reduction in long-term costs[1]

3. Guideline validation: Class 1a recommendation for imaging in complex lesions[1]

4. Adoption validation: Nearly fourfold increase demonstrates market acceptance[1]

5. Integration validation: Editorialists specifically call for “truly integrated platforms”[1]

6. Unmet need validation: CTO negative predictor proves gap in current imaging capabilities[1]

The path forward is clear:

1. Complete FDA 510(k) submission

2. Generate compelling clinical data in CTO procedures following Medicare study methodology[1]

3. Build strategic partnerships leveraging existing IVUS/OCT platforms for hybrid systems

4. Establish cost-effectiveness using the proven framework (35% premium, 21-30% long-term savings)[1]

5. Scale through focused commercialization targeting Western/Northeastern academic centers[1]

The convergence is undeniable:

• Clinical momentum: 2.6% annual growth in imaging adoption[1]

• Economic alignment: 21-30% long-term cost reduction justifies investment[1]

• Guideline support: Class 1a recommendation creates institutional imperative[1]

• Technology trends: Market seeking integrated platforms SFE completes[1]

• Unmet need: CTO negative predictor status (OR: 0.68) highlights gap[1]

• Market timing: Q3 2026 FDA submission positions VerAvanti to lead transformation

For patients with chronic total occlusions facing limited treatment options, forward-looking SFE technology promises to address the fundamental visualization challenge that current imaging cannot solve. For VerAvanti, the opportunity is to lead the field into the next era of image-guided intervention.

The Medicare study makes clear that the field is already moving decisively toward better visualization—with demonstrated outcome improvements of 13-16% across major endpoints.[1] The question isn’t whether interventional cardiology will embrace forward-looking imaging. The question is who will lead that transformation—and how quickly it will reach the patients who need it most.

The Medicare study has validated every element of the strategic thesis. The market is ready. The evidence framework exists. The economic model is proven. The clinical need is documented.

VerAvanti’s SFE technology provides the answer: forward-looking vision for forward progress in patient care.

References

[1] Medina FA, Mosarla RC, Kim JM, Li S, Song Y, Yeh RW, Secemsky EA. Adjunctive Imaging and Physiology During Percutaneous Coronary Intervention: Trends, Outcomes, and Costs Among Medicare Beneficiaries. JACC Cardiovasc Interv. 2026;19(1):15–27. doi: 10.1016/j.jcin.2025.09.047