Arteriovenous Fistula Devices Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Type (AVF Creation Devices {Surgical Instruments, Vascular Grafts, Angioplasty Balloons, Others}, AVF Monitoring Devices {Doppler Ultrasound, Pressure Monitoring Systems, Others}, AVF Maintenance Devices {Central Venous Catheters, Stents, Others}), By End-use (Hospitals, Cardiac Centers, Others), By Region, and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 344.32 Million
CAGR (2026-2031)	6.96%
Fastest Growing Segment	AVF Creation Devices
Largest Market	North America
Market Size (2031)	USD 515.57 Million

Market Overview

The Global Arteriovenous Fistula Devices Market will grow from USD 344.32 Million in 2025 to USD 515.57 Million by 2031 at a 6.96% CAGR. The Global Arteriovenous Fistula Devices Market consists of specialized medical instruments, including vessel clamps and surgical accessories, utilized to create a permanent connection between an artery and a vein for hemodialysis access. The market is primarily driven by the escalating prevalence of end-stage renal disease and the clinical preference for autogenous fistulas over synthetic grafts, owing to their superior patency rates and reduced risk of infection. According to the European Renal Association, in 2024, registry data indicated that 56% of patients receiving kidney replacement therapy were treated with hemodialysis, underscoring the critical reliance on functional vascular access for patient survival.

Despite the strong demand, the market faces a significant challenge regarding the high incidence of primary fistula maturation failure, where the surgical site fails to develop adequate blood flow for dialysis. This complication frequently necessitates corrective interventions or the use of temporary catheters, which increases healthcare costs and delays the initiation of effective life-saving therapy.

Key Market Drivers

The Rising Prevalence of End-Stage Renal Disease and Chronic Kidney Disease acts as the primary driver for the Global Arteriovenous Fistula Devices Market. As the patient population requiring renal replacement therapy expands, the necessity for reliable vascular access becomes paramount, with autogenous fistulas remaining the preferred modality due to superior patency. This escalating burden directly correlates with increased procurement of specialized surgical accessories needed for fistula creation. According to Fresenius Medical Care, March 2024, in the 'Annual Report 2023', approximately 4.2 million patients worldwide regularly undergo dialysis treatment, highlighting the massive patient base dependent on functional vascular access.

Advancements in Minimally Invasive and Percutaneous AVF Technologies are simultaneously reshaping the market by offering alternatives to open surgery. These innovations allow for fistula creation without large incisions, reducing trauma and improving cosmetic outcomes for patients. The adoption of these endovascular techniques is bolstered by clinical evidence demonstrating their safety profile. According to the National Institutes of Health, June 2024, in the study 'Multi-Center Two-Year Patency Outcomes of Endovascular Arteriovenous Fistulas Created with a 4 French System', the technical success rate for endoAVF creation was reported at 97.3%. Furthermore, the high volume of ongoing therapies underscores the critical nature of these devices, as according to DaVita Inc., in 2024, the total number of dialysis treatments administered in the U.S. during the fourth quarter of 2023 alone reached approximately 7.25 million.

Download Free Sample Report

Key Market Challenges

The high incidence of primary fistula maturation failure constitutes a substantial barrier to the expansion of the global arteriovenous fistula devices market. When a surgically created connection fails to develop adequate blood flow, the utility of the specific instruments and accessories used during the procedure is effectively nullified for that patient's immediate care. This clinical unpredictability discourages the consistent adoption of standard fistula creation devices, as healthcare providers may be compelled to utilize alternative vascular access methods, such as central venous catheters, which do not require these specialized tools. Consequently, the reliance on non-fistula alternatives directly reduces the volume of procedures utilizing fistula-specific devices.

Furthermore, the need for corrective interventions or prolonged catheter use due to maturation failure diverts financial resources that could otherwise support primary device procurement. This inefficiency hampers market momentum by associating fistula procedures with uncertain outcomes. According to the United States Renal Data System, in 2024, the Annual Data Report indicated that nearly 82% of incident hemodialysis patients initiated therapy with a catheter, a statistic frequently attributed to the failure of the fistula to mature in time for treatment. This persistent reliance on catheters underscores the difficulty manufacturers face in establishing fistulas as the universal standard, thereby limiting market growth potential.

Key Market Trends

The Development of Bioengineered Scaffolds to Accelerate Fistula Maturation is emerging as a transformative trend, addressing the critical bottleneck of vein non-maturation in hemodialysis access. Unlike traditional synthetic grafts, these acellular tissue-engineered vessels (ATEVs) are designed to repopulate with the patient’s own cells, potentially offering superior durability and infection resistance. This innovation specifically targets patients with unsuitable anatomy for autogenous fistulas, providing a regenerative alternative that reduces dependence on central venous catheters. According to Humacyte, Inc., July 2024, in the press release 'Humacyte Acellular Tissue Engineered Vessel (ATEV) Meets Primary Endpoints', the Phase 3 V007 clinical trial demonstrated that 81.3% of patients implanted with the ATEV maintained functional patency at six months, significantly outperforming the 66.4% rate observed in the standard autogenous fistula control group.

Simultaneously, the market is witnessing the Increasing Utilization of Drug-Coated Balloons (DCB) for Stenosis Management, driven by long-term clinical data validating their safety and efficacy over standard angioplasty. Stenosis, or the narrowing of the vessel, is the leading cause of fistula failure, and DCBs deliver anti-proliferative medication directly to the vessel wall to inhibit recurring blockages. Recent long-term studies have alleviated prior safety concerns regarding mortality risks associated with paclitaxel-coated devices, thereby reinvigorating their adoption as a standard of care for maintenance. According to Vascular News, April 2024, in the article 'We know which DCB to use—but many other questions remain in vascular access', five-year data from the IN.PACT AV Access study presented at the Charing Cross Symposium reported an all-cause mortality rate of 41% for the drug-coated balloon group, which was comparable to the 46.5% observed in the standard angioplasty group, confirming the long-term safety profile of the technology.

Segmental Insights

The AVF Creation Devices segment is currently positioning itself as the fastest-growing category within the Global Arteriovenous Fistula Devices Market. This rapid expansion is primarily driven by the increasing clinical preference for minimally invasive endovascular procedures over traditional open surgery. Recent approvals from regulatory entities, such as the US Food and Drug Administration, have validated systems that utilize radiofrequency or thermal energy to create fistulas without surgical incisions. Consequently, healthcare providers are adopting these technologies to reduce procedural trauma and enhance patient recovery, thereby fueling the specific demand for non-surgical creation devices.

Regional Insights

North America maintains a leading position in the Global Arteriovenous Fistula Devices Market due to the high prevalence of end-stage renal disease requiring dialysis. This dominance is supported by well-developed healthcare infrastructure and comprehensive reimbursement policies that facilitate patient access to necessary vascular access procedures. Additionally, the presence of major industry players and the ongoing approval of new devices by the U.S. Food and Drug Administration foster a favorable environment for market expansion. This combination of rising clinical demand and strong regulatory support ensures the region remains central to the global market.

Recent Developments

• In November 2025, Merit Medical Systems released significant 24-month efficacy results from the arteriovenous fistula arm of its WRAPSODY Arteriovenous Access Efficacy (WAVE) pivotal trial. The study data demonstrated that the WRAPSODY Cell-Impermeable Endoprosthesis achieved superior long-term vessel patency compared to standard percutaneous transluminal angioplasty in treating stenosis within the dialysis access circuit. These findings provided critical evidence supporting the device's ability to maintain blood flow and extend the interval between necessary maintenance procedures, highlighting the company's progress in delivering advanced therapeutic solutions for preserving functional vascular access.
• In April 2025, Venova Medical announced the completion of patient enrollment for the VENOS-2 clinical study, a pivotal trial evaluating the Velocity Percutaneous Arteriovenous Fistula (pAVF) System. This prospective, multicenter study was designed to gather essential clinical data on the safety and efficacy of the company's minimally invasive technology for creating vascular access in hemodialysis patients. The Velocity system allows physicians to establish a durable connection between the artery and vein using a catheter-based approach rather than open surgery, potentially lowering the risk of complications associated with traditional surgical fistula creation and offering a new option for patients.
• In April 2024, Concept Medical received an Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration for its MagicTouch AVF system. This regulatory milestone allowed the company to proceed with a pivotal clinical trial to evaluate the safety and effectiveness of its sirolimus drug-coated balloon catheter specifically for treating stenotic lesions in arteriovenous fistulas. The device was developed to address the high rates of restenosis often seen in dialysis access points, aiming to extend the functional life of the fistula and reduce the need for repeat interventions in patients suffering from chronic renal failure.
• In January 2024, Laminate Medical Technologies announced the successfully completed first commercial implantation of its VasQ External Vascular Support device in the United States following U.S. Food and Drug Administration approval. The procedure was performed at Spartanburg Regional Hospital and marked the commercial launch of the technology, which is designed to improve the success rates of surgically created arteriovenous fistulas. The VasQ device utilizes a nitinol-based external support structure that reinforces the connection between the artery and vein, optimizing blood flow and reducing mechanical stress to promote better fistula maturation and long-term patency for hemodialysis patients.

Key Market Players

• Medtronic PLC
• Becton, Dickinson and Company
• Teleflex Incorporated
• Fresenius Medical Care AG & Co. KGaA.
• B. Braun SE
• Poly Medicure Ltd.
• NxStage Medical, Inc.
• Laminate Medical Technologies Ltd.

By Type	By End-use	By Region
AVF Creation Devices {Surgical Instruments Vascular Grafts Angioplasty Balloons Others} AVF Monitoring Devices {Doppler Ultrasound Pressure Monitoring Systems Others} AVF Maintenance Devices {Central Venous Catheters Stents Others}	Hospitals Cardiac Centers Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Arteriovenous Fistula Devices Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Arteriovenous Fistula Devices Market, By Type:

• AVF Creation Devices {Surgical Instruments
• Vascular Grafts
• Angioplasty Balloons
• Others}
• AVF Monitoring Devices {Doppler Ultrasound
• Pressure Monitoring Systems
• Others}
• AVF Maintenance Devices {Central Venous Catheters
• Stents
• Others}

• Arteriovenous Fistula Devices Market, By End-use:

• Hospitals
• Cardiac Centers
• Others

• Arteriovenous Fistula Devices Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE