Recording a y-o-y growth of 3.8% in 2024, sales of EndoAVF devices in the United States & Europe are estimated to be valued at US$ 85.1 million in 2024. For the next ten years, a CAGR of 3.3% is on the cards for the United States & Europe EndoAVF device industry, with total valuation reaching US$ 118.3 million by 2034.
United States and Europe Endovascular Fistula Creation Device Industry Insights
| Attributes | Details |
|---|---|
| Base Value in 2023 | US$ 83.3 million |
| United States & Europe EndoAVF Device Industry Size in 2024 | US$ 85.1 million |
| United States & Europe Endovascular AVF Device Industry Revenue in 2034 | US$ 118.3 million |
| Value CAGR (2024 to 2034) | 3.3% |
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Since ancient times, healthcare professionals have been looking to develop new minimally invasive techniques and technologies to reduce complications. One such relatively new procedure is the EndoAVF, whose growing fame is becoming a catalyst triggering EndoAVF device sales.
Healthcare professionals increasingly use single-catheter systems and dual-catheter systems to create an arteriovenous fistula (AVF) for hemodialysis. Thus, growing prevalence of kidney diseases and escalating need for hemodialysis will propel demand for EndoAVF devices through 2034.
Compared to conventional surgical techniques, endovascular arteriovenous fistula technology considerably reduces the duration of surgical procedures. This is fueling its popularity, resulting in higher demand for endovascular AVF devices.
According to a study published in the Journal of Vascular and Interventional Radiology in September 2020, the Ellipsys EndoAVF was associated with lower procedure times (around 14 min) against surgical AVF (around 70 min). Hence, the high preference for EndoAVF devices among healthcare specialists to reduce procedure duration is anticipated to boost sales growth.
Sales of EndoAVF devices recorded a CAGR of 28.7% from 2019 to 2023, with total industry valuation reaching US$ 83.3 million at the end of 2023. In the assessment period, the EndoAVF device industry in the United States & Europe is slated to grow at 3.3% CAGR.
Before the introduction of the EndoAVF procedure, open-access procedures were commonly performed to access the vascular lumen. However, they have numerous complications, such as infections, and also result in poor patient care experience, prompting healthcare professionals to opt for novel procedures like EndoAVF.
In 2018, Ellipsys EndoAVF technology was approved by the FDA, which transformed the complex surgery into minimal invasive procedure. This thermal resistance anastomosis device (TRAD) is used to develop an anastomosis using heat and pressure.
More recently, an innovative technology, the WavelinQ system, that uses a dual-catheter system has been introduced. Development and approval of these new devices will positively impact industry growth through 2034.
To date, there are only two players operating within this high-potential industry. But recently, many new startups are also gearing up to make an entry.
For example, Pathfinder Medical, which is a medical device company headquartered in London, recently received a grant of US$ 1.4 million from Innovate UK, the national innovation agency. This fund will help the company to develop minimally invasive endovascular arteriovenous fistula (EndoAVF).
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Patients and healthcare providers are becoming more aware of the potential benefits of EndoAVF technologies, including their less invasive nature, increased efficiency, and better patient outcomes. This is anticipated to fuel demand for EndoAVF devices through 2034.
New targeted marketing campaigns and educational programs are being launched to educate people about the benefits of minimally invasive procedures like EndoAVF. This raising of knowledge will positively impact growth of the United States & Europe EndoAVF device industry.
Healthcare professionals in remote locations are now more likely to incorporate EndoAVF devices into their vascular access practices as a result of growing awareness and acceptability. This can ultimately create opportunities for the endovascular AVF devices industry’s growth.
Collaboration among the major industry participants facilitates the development and approval of endovascular AVF devices faster. Healthcare providers can offer valuable information to device manufacturers, which helps them ensure that EndoAVF devices meet the unique requirements of patients and medical professionals.
Working together with regulatory agencies speeds up the clearance and market launch of these advanced products by ensuring that strict standards are met with minimal hassle and no need for repeat clearances/inspections. Consequently, this gives healthcare practitioners access to modern and authorized EndoAVF solutions, increasing their range of available treatments.
By providing a supporting ecosystem that encourages creativity, safety, and efficiency in vascular access methods, this synergy speeds up the adoption of EndoAVF technology. Hence, a steady CAGR has been predicted for the endovascular AV fistula creation system industry through 2034.
Despite the significant opportunity for endovascular AVF creation device industry, complications associated with endovascular AVF devices act as a major restraint. The adoption of EndoAVF devices may be hindered by the known risks connected to the WavelinQ and Ellipsys systems for EndoAVF procedures.
These include hematomas, contrast extravasation, pseudoaneurysms, brachial artery dissections, and pseudoaneurysms induced by radiofrequency (RF) energy application.
Even though challenges are usually moderate and can be resolved with extra endovascular intervention, some healthcare providers do not adopt such treatment options. Irrespective of their potential for correction, the presence of these problems can increase worries about the security and effectiveness of EndoAVF treatments.
Hence, such complications associated with these devices may lower the adoption of these devices and could create a barrier to the growth of the EndoAVF device industry.
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The section comprehensively evaluates three interrelated industries: the United States & Europe endovascular AVF device sector, the vascular access system industry, and the arteriovenous fistula treatment industry. It provides distinctive characteristics of each industry, including their CAGRs, while delving into the pivotal factors that influence their growth trajectories.
United States and Europe EndoAVF Device Industry Analysis:
| Attributes | United States and Europe EndoAVF Device Industry Outlook |
|---|---|
| CAGR (2024 to 2034) | 3.3% |
| Growth Factor | Growing incidence of end-stage kidney disease (ESRD) is set to boost growth of the Endovascular AVF device industry in the United States and Europe. |
| Key Trends in the EndoAVF Device Industry in the United States & Europe | Escalating preference for minimally invasive procedures is a key trend shaping growth. |
Global Vascular Access System Industry Analysis:
| Attributes | Global Vascular Access System Industry Analysis |
|---|---|
| CAGR (2024 to 2034) | 6.6% |
| Growth Factor | Growing prevalence of cardiovascular diseases and spike in vascular access surgeries will boost industry growth. |
| Key Trends in Vascular Access Device Industry | A key growth influencing trend is the surging interest in minimally invasive procedures. |
Global Arteriovenous Fistula Treatment Industry:
| Attributes | Global Arteriovenous Fistula Treatment Industry |
|---|---|
| CAGR (2024 to 2034) | 5.9% |
| Growth Factor | High incidence of ESRD globally is forecast to create demand for arteriovenous fistula treatment. |
| Key Trends in Arteriovenous Fistula Treatment Industry | Growing awareness of the benefits of AVF and favorable government support will further boost industry growth. |
The table below shows the estimated growth projection of the top nations. Germany and the United Kingdom are set to witness high adoption of endovascular AVF devices, recording CAGRs of 4.2% and 4.1%, respectively, through 2034.
Growth Outlook by Key Countries
| Countries | Value CAGR |
|---|---|
| United States | 2.8% |
| United Kingdom | 4.1% |
| Germany | 4.2% |
| France | 3.7% |
| Italy | 3.5% |
| Spain | 4.0% |
As per the latest analysis, the United States will remain the prominent consumer of endovascular AVF devices, holding 61.7% industry share in 2024. Over the next ten years, the United States EndoAVF device industry is set to grow at 2.8% CAGR.
Several factors are providing impetus for the growth of the endovascular AVF device industry in the nation. These include escalating prevalence of kidney diseases, growing preference for minimally invasive procedures, and favorable government support.
According to the American Kidney Fund, around 37 million Americans have kidney disease and are potential customers of the EndoAVF procedure. This, in turn, will continue to create demand for endovascular AVF devices such as single-catheter systems and dual-catheter systems.
Availability of insurance coverage for hemodialysis in the United States is also positively impacting industry growth. Similarly, escalating trend of home-based dialysis will fuel EndoAVF device sales in the nation through 2034.
Germany is anticipated to offer lucrative growth opportunities to endovascular AVF device manufacturers during the forecast period. This can be attributed to growing incidence of end-stage renal disease (ESRD) and escalating awareness of the benefits of EndoAVF.
The latest FMI analysis estimates Germany's endovascular AVF device industry value to total US$ 12.8 million in 2024. Demand for EndoAVF devices in the country is set to surge at 4.2% CAGR, making Germany a highly lucrative pocket across Europe.
According to health insurance data, around 100,202 patients required dialysis in Germany in 2017. This figure is projected to increase by 20% to 23% in 2041, which will propel demand for endovascular AVF devices.
Hemodialysis patients are required to undergo minimal invasive EndoAVF procedures to create AV fistulas because they require large-lumen vascular access. This leads to the rise of endovascular AVF device usage and, consequently, industry growth in Germany.
The section below sheds some light on leading segments along with their projected growth rates. Companies can use this information to invest in popular products to solidify their positions in the United States & Europe EndoAVF industry.
Based on product, single-catheter system segment is set to dominate the industry, accounting for a value share of 88.2% in 2024. By technology, the thermal resistance segment is forecast to grow at a high CAGR of 3.4% through 2034. By end-user, hospitals will account for a prominent industry share of 57% in 2034.
Growth Outlook by Product
| Product | Value CAGR |
|---|---|
| Single-catheter System | 3.4% |
| Dual-catheter System | 2.7% |
Demand is anticipated to remain high for single-catheter systems during the assessment period. As per the latest report, the target segment is set to generate a revenue of US$ 75.12 million in 2024 and will record a CAGR of around 3.4% over the next ten years.
The dominance of single-catheter system category can be attributed to several factors. These include the simple nature, ease of use, and cost-effectiveness of single-catheter systems, which are encouraging their adoption across hospitals and other healthcare facilities.
Doctors widely use single-catheter systems due to their multiple advantages. They are easy to navigate and handle while performing endovascular procedures. This reduces the risk of unwanted complications.
Growth Outlook by Technology
| Technology | Value CAGR |
|---|---|
| Thermal Resistance | 3.4% |
| Radiofrequency Pulse | 2.7% |
As per the latest report, the thermal resistance segment will retain its dominance, holding a share of 88.1% in 2024. In the forecast period, the target segment is set to grow at 3.4% CAGR.
Thermal resistance is used in single catheter systems in which anastomosis is created using heat and pressure. Spike in patients with end-stage kidney disease makes it imperative for them to opt for dialysis, resulting in higher demand for thermal resistance-based EndoAVF devices.
The recent introduction of EndoAVF technology has transformed patient care. This is because it is a minimally invasive procedure that allows for access to vascular lumen during dialysis.
A single catheter system is commonly used during the EndoAVF procedures. Since the single catheter system is the most prevalent EndoAVF device, this makes thermal resistance dominating technology in endovascular AVF device industry.
Growth Outlook by End-user
| End-user | Value CAGR |
|---|---|
| Hospitals | 1.6% |
| Ambulatory Surgical Centers | 3.8% |
| Dialysis Centers | 7.0% |
When it comes to EndoAVF device adoption, hospitals lead from the forefront. The target segment is set to grow at a CAGR of 1.6% during the forecast period. It will hold around 57.0% of the United States & Europe EndoAVF device industry share in 2024.
Hospitals remain the leading end users of endovascular AVF devices across the United States and Europe. This can be attributed to high volume of endovascular arteriovenous fistula procedures being performed in hospitals.
Availability of highly qualified medical professionals and advanced imaging equipment in hospitals is encouraging patients to opt for treatments in these settings. This will result in a high volume of procedures like EndoAVF in hospitals, boosting segment growth.
Leading manufacturers of EndoAVD devices are rigorously investing in research and development to develop novel devices with enhanced features. They are also looking to strengthen their presence in lucrative regions through new facility establishments, mergers, acquisitions, and partnerships.
Companies are also receiving government support through grants for research activities. Many new products are being introduced and tested on patients in post-surveillance studies to establish their safety.
Recent Developments in the United States and Europe Endovascular AVF Device Industry
| Attribute | Details |
|---|---|
| Industry Value in 2024 | US$ 85.1 million |
| Industry Size in 2034 | US$ 118.3 million |
| Growth Rate (2024 to 2034) | 3.3% CAGR |
| Forecast Period | 2024 to 2034 |
| Historical Data Available for | 2019 to 2023 |
| Industry Analysis | US$ million for Value |
| Key Regions Covered | United States and Europe |
| Key Countries Covered | United States, Germany, United Kingdom, France, Italy, and Spain |
| Key Industry Segments Covered | Product, Technology, End-user, and Country |
| Key Companies Profiled | BD; Medtronic Plc |
The target industry value is estimated to total US$ 85.1 million in 2024.
Demand in the United States & Europe is set to rise at 3.3% CAGR.
The United States & Europe EndoAVF devices industry size is set to reach US$ 118.3 million by 2034.
With 88.2% share in 2024, the single-catheter system segment dominates the industry.
The target industry registered a 28.7% CAGR from 2019 to 2023.
The United States industry value is set to total US$ 52.5 million in 2024.
Quick recovery and minimally invasive nature are some benefits of EndoAVF.
1. Executive Summary 1.1. United States and Europe Market Outlook 1.2. Demand Side Trends 1.3. Supply-Side Trends 1.4. Analysis and Recommendations 2. Market Overview 2.1. Market Coverage / Taxonomy 2.2. Market Definition / Scope / Limitations 2.3. Inclusions and Exclusions 3. Key Market Trends 3.1. Key Trends Impacting the Market 3.2. Development/Innovation Trends 4. Value-Added Insights 4.1. Product Adoption Analysis 4.2. Company V/S Product Matrix 4.3. Regulatory Landscape 4.3.1. Legal Requirements and Frameworks in the United States 4.3.2. Legal Requirements and Frameworks in Europe 4.4. Factors influencing the choice of VA 4.5. New device and technologies for hemodialysis vascular access 4.6. Difference between EndoAVF device and Surgery 4.7. Porter’s Analysis 4.8. PESTEL Analysis 5. Market Background 5.1. Macro-Economic Factors 5.1.1. United States and Europe Healthcare Expenditure 5.1.2. R&D funding by Region 5.2. Forecast Factors - Relevance & Impact 5.2.1. Key Player’s Historic Growth 5.2.2. Prevalence of Arteriovenous fistulas 5.2.3. Adoption of EndoAVF across Countries 5.2.4. Cost of Product 5.2.5. Availability of Products 5.2.6. Need for minimal invasive procedure 5.2.7. Technological Advancements 5.2.8. Regulatory Dynamics 5.3. Market Dynamics 5.3.1. Drivers 5.3.2. Restraints 5.3.3. Opportunity Analysis 6. Market Demand (in Value or Size in US$ million) Analysis 2019 to 2023 and Forecast, 2024 to 2034 6.1. Historical Market Value (US$ million) Analysis, 2019 to 2023 6.2. Current and Future Market Value (US$ million) Projections, 2024 to 2034 6.2.1. Y-o-Y Growth Trend Analysis 6.2.2. Absolute $ Opportunity Analysis 7. Market Analysis 2019 to 2023 and Forecast 2024 to 2034, By Product 7.1. Introduction / Key Findings 7.2. Historical Market Size (US$ million) by Product, 2019 to 2023 7.3. Current and Future Market Size (US$ million) and Forecast by Product, 2024 to 2034 7.3.1. Single-catheter System 7.3.2. Dual-catheter System 7.4. Market Attractiveness Analysis by Product 8. Market Analysis 2019 to 2023 and Forecast 2024 to 2034, By Technology 8.1. Introduction / Key Findings 8.2. Historical Market Size (US$ million) By Technology 2019 to 2023 8.3. Current and Future Market Size (US$ million) Analysis and Forecast by Technology, 2024 to 2034 8.3.1. Radiofrequency Pulse 8.3.2. Thermal Resistance 8.4. Market Attractiveness Analysis by Technology 9. Market Analysis 2019 to 2023 and Forecast 2024 to 2034, By End User 9.1. Introduction / Key Findings 9.2. Historical Market Size (US$ million) By End User, 2019 to 2023 9.3. Current and Future Market Size (US$ million) Analysis and Forecast by End User, 2024 to 2034 9.3.1. Hospitals 9.3.2. Ambulatory Surgical Centers 9.3.3. Dialysis Centers 9.4. Market Attractiveness Analysis by End User 10. Market Analysis 2019 to 2023 and Forecast 2024 to 2034, By Country 10.1. Introduction / Key Findings 10.2. Historical Market Size (US$ million) Trend Analysis by Country, 2019 to 2023 10.3. Current and Future Market Size (US$ million) Analysis and Forecast by Country, 2024 to 2034 10.3.1. United States 10.3.2. Germany 10.3.3. United Kingdom 10.3.4. France 10.3.5. Italy 10.3.6. Spain 10.4. Market Attractiveness Analysis by Country 11. United States Market Analysis 2019 to 2023 and Forecast 2024 to 2034 11.1. Introduction 11.2. Historical Market Size (US$ million) Trend Analysis by Market Taxonomy, 2019 to 2023 11.3. Current and Future Market Size (US$ million) Analysis and Forecast by Market Taxonomy, 2024 to 2034 11.3.1. By Product 11.3.2. Technology 11.3.3. By End User 11.4. Market Attractiveness Analysis 11.4.1. By Product 11.4.2. By Technology 11.4.3. By End User 11.5. Drivers & Restraints Impact Analysis 12. Germany Market Analysis 2019 to 2023 and Forecast 2024 to 2034 12.1. Introduction 12.2. Historical Market Size (US$ million) Trend Analysis by Market Taxonomy, 2019 to 2023 12.3. Current and Future Market Size (US$ million) Analysis and Forecast by Market Taxonomy, 2024 to 2034 12.3.1. By Product 12.3.2. By Technology 12.3.3. By End User 12.4. Market Attractiveness Analysis 12.4.1. By Product 12.4.2. By Technology 12.4.3. By End User 12.5. Drivers & Restraints Impact Analysis 13. United Kingdom Market Analysis 2019 to 2023 and Forecast 2024 to 2034 13.1. Introduction 13.2. Historical Market Size (US$ million) Trend Analysis by Market Taxonomy, 2019 to 2023 13.3. Current and Future Market Size (US$ million) Analysis and Forecast by Market Taxonomy, 2024 to 2034 13.3.1. By Product 13.3.2. By Technology 13.3.3. By End User 13.4. Market Attractiveness Analysis 13.4.1. By Product 13.4.2. By Technology 13.4.3. By End User 13.5. Drivers & Restraints Impact Analysis 14. France Market Analysis 2019 to 2023 and Forecast 2024 to 2034 14.1. Introduction 14.2. Historical Market Size (US$ million) Trend Analysis by Market Taxonomy, 2019 to 2023 14.3. Current and Future Market Size (US$ million) Analysis and Forecast by Market Taxonomy, 2024 to 2034 14.3.1. By Product 14.3.2. By Technology 14.3.3. By End User 14.4. Market Attractiveness Analysis 14.4.1. By Product 14.4.2. By Technology 14.4.3. By End User 14.5. Drivers & Restraints Impact Analysis 15. Italy Market Analysis 2019 to 2023 and Forecast 2024 to 2034 15.1. Introduction 15.2. Historical Market Size (US$ million) Trend Analysis by Market Taxonomy, 2019 to 2023 15.3. Current and Future Market Size (US$ million) Analysis and Forecast by Market Taxonomy, 2024 to 2034 15.3.1. By Product 15.3.2. By Technology 15.3.3. By End User 15.4. Market Attractiveness Analysis 15.4.1. By Product 15.4.2. By Technology 15.4.3. By End User 15.5. Market Trends 15.6. Drivers & Restraints Impact Analysis 16. Spain Market Analysis 2019 to 2023 and Forecast 2024 to 2034 16.1. Introduction 16.2. Historical Market Size (US$ million) Trend Analysis by Market Taxonomy, 2019 to 2023 16.3. Current and Future Market Size (US$ million) Analysis and Forecast by Market Taxonomy, 2024 to 2034 16.3.1. By Product 16.3.2. By Technology 16.3.3. By End User 16.4. Market Attractiveness Analysis 16.4.1. By Product 16.4.2. By Technology 16.4.3. By End User 16.5. Market Trends 16.6. Drivers & Restraints Impact Analysis 17. Market Structure Analysis 17.1. Market Share Analysis of Top Players (%) 17.2. Market Presence Analysis 18. Competition Analysis 18.1. Competition Dashboard 18.2. Competition Deep Dive 18.2.1. BD 18.2.1.1. Overview 18.2.1.2. Product Portfolio 18.2.1.3. Key Financials 18.2.1.4. SWOT Analysis 18.2.1.5. Key Developments 18.2.1.6. Sales Footprint 18.2.1.7. Strategy Overview 18.2.2. Medtronic 19. Assumptions and Acronyms Used 20. Research Methodology
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EndoAVF Device Industry Analysis in the United States and Europe
