Intravascular Lithotripsy Holds Promise 2:1 Versus Absorbable Stents In PAD

Vascular surgeons and interventional radiologists, showed twice the level of enthusiasm for the opportunities offered by Intravascular Lithotripsy (IVL) than the next technology believed to show most promise, absorbable stents, in offering innovation in Peripheral Arterial Disease PAD treatment over the next three years.

medintel surveyed 162 physicians (interventional radiologists, vascular surgeons) from across the EU and US, and 33% of physicians named IVL as the technology they're most excited about over the next three years. This represents more than double the interest in the next category, absorbable stents/biodegradable scaffolds at 16%. Similar differences were seen with only 14% of physicians excited about the possibilities for atherectomy and the same for drug eluting technology.

Technology physicians are most excited about the potential of in PAD. Surveyed in March 2025.

Intravascular Lithotripsy technology is rapidly transforming the treatment landscape for Peripheral Arterial Disease, with significant growth opportunities forecast. Tibial vessels are highlighted as the highest potential growth area for IVL technology as new, lower-profile devices with longer balloons enter the market.

IVL has revolutionised calcium management in vascular procedures. Physicians report IVL is dramatically reducing the need for stenting in femoral-popliteal treatments while improving safety profiles compared to traditional atherectomy.

‘IVL has transformed calcium management over the last few years,’ notes Kilian Toal, Director at medintel. ‘The ease of use, short learning curve, and applicability across most vessels mean it is rapidly becoming the first choice for many physicians in preparation for severe calcific disease.’

IVL is viewed by physicians as especially beneficial when treating diabetic and end-stage renal disease patients, populations projected to grow significantly in coming years.

While Shockwave Medical currently dominates the IVL market, competitive devices from companies including Bolt Medical, Abbott (through CSI acquisition), and FastWave Medical are in development or early clinical trials.

Market competition is expected to intensify as reimbursement policies catch up with clinical practice and the growing evidence base continues to demonstrate IVL's effectiveness.

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KOLs on Vascular Access Challenges in 2025

Leading EU and US vascular access specialists this month discussed critical developments in the field. Two topics of debate were the recent withdrawal of endoAVF devices and the need for the development protocols on high-flow fistula management.

Medtronic Withdraws Ellipsis EndoAVF Device

In a surprising development, Medtronic has withdrawn its Ellipsis endovascular arteriovenous fistula (endoAVF) device from the market. Despite positive clinical outcomes and strong patient preference due to cosmetic advantages and fewer complications, adoption challenges and cost barriers appear to have influenced this decision. Experts noted the device faced reimbursement hurdles in several markets despite commanding 85-90% of the global percutaneous fistula market. Despite the withdrawal, there is optimism about the future of endoAVFs with new technologies like the VENOS 2 study. The VENOS 2 study involves a new device that simplifies the procedure and shows early promise. Experts highlighted the need for a second-generation device to reduce the number of procedures required for fistula maturation.

High-Flow Fistulas Present Unaddressed Challenges

Experts interviewed identified high-flow fistulas as a significant yet under-recognised clinical challenge, particularly in post-transplant patients. With flows reaching two to three litres—effectively tripling cardiac output—these fistulas can cause considerable cardiovascular strain. Despite this, systematic follow-up and management algorithms remain lacking. Discussions emphasised the importance of monitoring and potentially intervening in high flow fistulas to prevent complications. Experts believed there is a need for more rigorous follow-up and research to develop strategies for managing high flow fistulas.

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Robotic Surgery After 30 Years Still Faces Adoption Challenges

Robotic surgery, now entering its third decade of clinical use, has revolutionised minimally invasive procedures across multiple specialties but medintel finds it still continues to face adoption hurdles.

Expanding Surgical Applications

Originally pioneered in urology, robotic platforms received FDA approval for gynecological applications in 2005. Applications have since expanded to ENT, cardiothoracic, general, and colorectal surgery. In gynecology, use has evolved from hysterectomies to pelvic floor repairs, myomectomies, and complex endometriosis cases.

‘Technology enhances skill, it does not replace it’

Robotic systems enhance surgical capabilities through improved precision, visibility, and ergonomics, but complement rather than replace expertise. Earlier complications stemmed primarily from inadequate surgical experience rather than technological limitations.

‘These platforms are sophisticated tools requiring proper training and sound surgical judgment’ explains a surgical director to medintel. ‘They enable minimally invasive approaches for complex cases but remain dependent on the surgeon's skill.’

Economic Realities Affect Implementation

Clinical evidence indicates robotic surgery can shorten hospital stays while reducing complications and readmission rates. However, realising these benefits requires sufficient platforms to serve surgical teams—a significant challenge in resource-constrained environments.

The pandemic has increased waiting times for non-urgent procedures, particularly in specialties like endometriosis surgery, driving more patients toward private care where robotics are more accessible.

Future Innovations

Recent advances include single-port systems for complex cases, though these await regulatory approval for gynecological applications. While AI is emerging in surgical training environments, autonomous robotic surgery remains distant due to the subjective nature of surgical decision-making.

The primary barrier to wider adoption remains economic, as more affordable systems with comparable quality are needed for full integration into healthcare systems worldwide.

ENDS

AI's Role In Research: Linear Connections Not Lateral

medintel continues to test the possibilities of the latest AI platforms, and utilise how AI with phenomenal analytical results while safeguarding data privacy and maintaining standards in accuracy and validity.

The massive boost to productivity, and speed of turnaround of immediate topline findings is a significant benefit as well as the ability to interrogate data to pursue lines of enquiry.

However, the one-sided nature of the enquiry means it needs to be treated carefully and can easily result in false positives.

The lack of the ability for the researcher to see the whole picture in the data and see fresh perspectives can be a challenge. Researchers need to know the data to see the wider picture. In addition detailed storytelling still needs to be very much guided. AI serves as a powerful collaborative tool rather than a replacement for human expertise: for the time being anyway!

AI as Research Assistant, Not Replacement

‘The most successful researchers view AI as an extension of their capabilities, not a substitute for their expertise,’ was noted on a recent forum of qualitative researchers.

AI Does Not Think Laterally: It Is Built On Linear Connections

AI is built on a series of yes, no, yes, no linear connections. It is not intuitively designed to think laterally. When humans think laterally, they make creative leaps between concepts, draw unexpected connections, and approach problems from unconventional angles. This often involves intuition, emotional context, and life experiences.

AI systems can simulate aspects of lateral thinking by making connections between seemingly unrelated concepts in training data; generate multiple approaches to solving problems and identify patterns across different domains.

However, AI lateral thinking doesn’t have genuine intuition or emotional context that often drives human creativity. AI connections are based on statistical patterns in training data rather than lived experience. As Claude AI describes:

‘I don't have the embodied understanding that humans develop through physical interaction with the world.’

Freeing Researchers for Higher-Value Work

This limitation aside, AI technology excels at handling repetitive tasks including transcript processing, pattern recognition, and response clustering. This efficiency creates more space for researchers to focus on deeper analysis and meaningful connections.

Recognising Critical Limitations

There are significant limitations in current AI capabilities, particularly regarding emotional intelligence and cultural context and the one directional nature of the enquiry. AI outputs accepted without critical evaluation, especially under deadline pressure are a concern.

Strategic Implementation Critical

The most effective AI integration occurs when technology is used as a reflective partner that helps identify bias and validate conclusions rather than generating independent insights. This approach creates what one participant called "an inexhaustible thought partner" that enhances rather than replaces human expertise.

A Collaborative Future

Like with most professions, AI is firmly part of the future of research, and as it evolves it may well lead to a shrinking workforce. AI certainly has the potential to mean greater volume of research done by fewer humans, but the human touch to guide the interrogation and pitch the narrative appropriate to the audience will likely remain.

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KOLs On PAD Innovations And Challenges In 2025

medintel interviewed leading vascular specialists to discuss advances in Peripheral Arterial Disease (PAD) treatments to understand key innovations.

Bioresorbable Scaffolds Show Promise Below the Knee

Following the successful LIFE BTK trial, bioresorbable scaffolds have emerged as potential game-changers for below-knee interventions. This technology addresses both mechanical and biological factors affecting vessel patency. While experts expressed enthusiasm about devices like Abbott's Esprit™ BTK System scaffold, they cautioned about efficacy in longer lesions and suggested potential future applications beyond below-knee territories.

Limus-Based Therapies Gain Momentum

Development of sirolimus-coated balloons has accelerated, particularly for below-knee applications where paclitaxel devices have shown limited efficacy. The SIRONA trial demonstrated non-inferiority of sirolimus versus paclitaxel above the knee at one year. Specialists noted limus-coated devices show reduced distal embolization issues, though technical challenges in drug delivery remain.

Evidence Gap in Vessel Preparation Techniques

Despite widespread use of vessel preparation methods including specialty balloons, lithotripsy, and atherectomy, experts highlighted the lack of robust evidence demonstrating improved outcomes. High-cost devices require stronger proof of clinical benefit, with successful strategies likely needing combination with definitive treatments rather than functioning independently.

ENDS

Challenges of Ethnographic Research on Continuous Glucose Monitoring

A recent ethnographic project on Continuous Glucose Monitoring use among Type 1 Diabetes Patients in the US and Germany made use reflect on the following project management issues:

Recruitment and Selection Barriers

Finding representative participants for ethnographic research on continuous glucose monitoring (CGM) devices presented significant challenges in a recent study in US and Germany. In the US, the fragmented healthcare system creates access disparities, making it difficult to recruit across socioeconomic boundaries. Many lower-income patients lack access to advanced CGM technologies, potentially biasing research toward more affluent participants. In Germany, despite universal healthcare, we found recruitment often requires navigating multiple clinical gatekeepers and regional health authorities, extending timelines and adding administrative complexity.

Cultural Differences in Health Technology Perception

American and German patients approach health technology differently, complicating comparative analysis. US patients often view CGMs through a consumer technology lens, focusing on features and convenience. German patients typically prioritize precision, reliability, and data privacy, reflecting broader cultural attitudes toward healthcare and technology. These differences influence how patients interact with devices and their willingness to share experiences, requiring researchers to adapt their methodological approaches for each context.

Data Privacy and Regulatory Compliance

Germany's strict data protection laws under GDPR created additional hurdles for collecting observational data about CGM use in natural settings. Requirements around explicit consent for each data collection point posed a challenge for ethnographic work. The US presents different challenges with HIPAA compliance and varied state-level privacy regulations, particularly when research crosses insurance and provider boundaries.

Technology Ecosystem Variations

The surrounding technology ecosystem significantly impacts CGM usage patterns. US patients typically use a wider range of connected apps and digital platforms to manage their diabetes, while German users often rely more heavily on their primary healthcare provider's recommended systems. We had to account for these different ecosystems when analysing how patients integrate CGMs into their daily diabetes management routines.

Longitudinal Engagement Challenges

Maintaining consistent participation proved a challenge both countries. In the US, high patient mobility and insurance changes caused challenges. German participants may exhibit greater stability but often show more reluctance toward continuous remote monitoring aspects of research, particularly when it involves sharing data outside their immediate healthcare environment.

Market Engagement Model

Introduction

Our engagement approaches are tailored to each client's unique needs, ranging from value-proposition workshops to executive education, team coaching, and project consulting.

Below is our structured seven-phase model that guides successful market engagements.

Phase 1: Situation Analysis

This initial phase evaluates current market positioning, identifying existing value propositions and delivery systems. We assess how effectively these deliver value to customers and shareholders, and examine vulnerabilities against market trends and disruptions.

Phase 2: Common Language and Customer Mindset

We establish a shared customer-centric framework for your team. This provides essential tools to understand customer needs while building organisational buy-in for the reinvention process.

Phase 3: Research Preparation

We synthesize current knowledge about unmet customer needs in target segments. Role-playing exercises help formulate initial hypotheses about promising opportunities, preparing teams for field research.

Phase 4: Customer Field Research

We study actual customers whose lives we aim to improve, identifying problems they may not recognize themselves. This typically involves 10-15 in-depth interviews per market opportunity, professionally facilitated to capture maximum insights.

Phase 5: Value Architecture

Using research insights, we develop improved customer scenarios with superior value propositions and delivery systems. These define the ideal future state that solves customer problems in innovative ways, specifying experiences and price points that motivate customers to choose your solutions.

Phase 6: Concept Testing

We create narrative descriptions of new scenarios to test with customers. Team members revisit selected customers to validate these concepts, confirming their potential success or identifying necessary revisions.

Phase 7: Finalization and Launch

We evaluate, refine, and implement the most promising value propositions. This includes developing business cases and estimating market potential.

Maximising Impact Through Strategic Market Research

The Critical Role of Research in Healthcare Innovation

In today's competitive healthcare landscape, the difference between products is increasingly marginal, making effective research essential before product introduction. Well-designed research ensures new healthcare products are not only clinically efficacious but also effective and acceptable in real-world settings. Understanding end-users and the healthcare-commercial ecosystem is crucial for maximizing impact and return on investment across all development stages.

Integrating Research Throughout the Product Lifecycle

Social and behavioral research should operate alongside product development as a critical component of the process. These techniques help answer market-critical questions about current behaviors, unmet needs, evaluation criteria, system challenges, and innovation opportunities. Appropriate research supports decision-making at all lifecycle stages—from early concept development through launch and post-market monitoring—significantly reducing risk at decision-making milestones.

Key Research Approaches for Different Development Phases

Different research methodologies serve specific phases of product development. Early-stage research focuses on needs assessment and concept testing. Mid-stage development benefits from product refinement studies and human-centered design approaches. Launch-phase research emphasizes message testing and market forecasting, while post-launch efforts concentrate on tracking studies and further refinement opportunities.

Essential Market Research Principles

Six critical principles emerge from successful market research: (1) Innovation should be continuous rather than seeing products as "finished"; (2) Comprehensive market understanding requires including all stakeholders and avoiding assumptions; (3) Testing should examine context and ideas surrounding the product, not just the product itself; (4) Research should strengthen products, not merely evaluate them; (5) Rigorous forecasting is essential for appropriate planning; (6) Ongoing tracking sustains success even after launch.

Effective Implementation Strategies

For maximum benefit, research should be incorporated from the earliest stages—even before concept development. Professional research partners help ensure appropriate design and execution. The actionability of findings depends on employing correct methodologies and ensuring outcomes inform organizational planning. This approach optimizes public health interventions by developing strong understanding of all relevant stakeholders from end-users to product developers, commercial groups, and government entities.

Qualitative Research Techniques: Understanding Patient Quality of Life

We recently completed an in-depth study with diabetes patients, and wanted to reflect on some of the projective techniques the team used to elicit information.

Visual Exploration Methods

Image-Based Expression: We asked diabetes patients to create collages representing their daily experiences with the condition. This helped us uncover emotional dimensions that standard questionnaires might miss. When patients selected images showing isolation during mealtimes or anxiety in social settings, they revealed quality of life challenges they hadn't articulated in direct questioning. Their explanations of these visual choices provided rich insights into lived experiences.

Archetype Analysis: Presenting Archetypes to patients revealed how they viewed themselves at different stages of their diabetes journey. This technique helped us understand the psychological evolution from diagnosis through adaptation. Many initially identified with a Victim archetype but transitioned to Hero or Caregiver as they mastered self-management.

Disease Experience Personification

Character Development: Having patients describe diabetes as a person in their lives uncovered profound emotional relationships with the condition. This metaphorical approach helped us identify that many long-term patients personified their diabetes as an "unwelcome roommate" they had learned to accommodate rather than a "mortal enemy" to be fought.

Contextual Scenarios: Scenario exercises like "hosting a dinner party while managing diabetes" illuminated social challenges that significantly impacted quality of life. These discussions helped us identify previously unrecognized barriers to treatment adherence in social contexts.

Interactive Exploration

Recognition Activities: Device and medication identification exercises sparked productive discussions about treatment experiences. This approach helped us understand how physical interactions with management tools affected emotional wellbeing and treatment satisfaction.

Classification Exercises: Having patients sort aspects of diabetes management into categories revealed that continuous glucose monitoring caused less life disruption than previously assumed, while dietary restrictions created more significant quality of life burdens than clinicians typically recognized.

Narrative Techniques

Creative Writing: Patient-written letters to newly diagnosed individuals helped us identify emotional milestones in the adaptation process that healthcare providers often overlooked when developing support programs.

Situational Storytelling: Patient narratives about navigating healthcare systems uncovered systematic barriers to optimal care that directly impacted quality of life, particularly around appointment scheduling and medication access.

Supplementary Methods

Association Mapping: Placing care elements in concentric circles helped us visualize which aspects of diabetes management created the greatest burden, revealing that administrative tasks often caused more distress than medical procedures.

These techniques provided deeper insights into diabetes patients' lived experiences beyond clinical measures, fundamentally reshaping our understanding of quality of life factors in diabetes management.