Arteriovenous Fistula (AVF) Devices Market By Product Type (AVF Creation Devices, AVF Maintenance Devices); By Application (Hemodialysis Access, Pediatric Renal Care, Clinical Trials and Research); By End User (Hospitals, Outpatient Dialysis Clinics, ASCs, Research Institutes); By Geography, Segment Revenue Estimation, Forecast, 2026–2032

Arteriovenous Fistula Devices Market: Embolization Platforms and Dialysis-Access Systems Expand Treatment Across Multiple AVF Type

The Global Arteriovenous Fistula (AVF) Devices Market was estimated to reach USD 1.03 billion in 2025 and is projected to grow to USD 1.76 billion by 2032, expanding at a CAGR of 7.9%, driven by hemodialysis vascular access demand, percutaneous AVF creation, endovascular AVF adoption, ultrasound-guided AVF procedures, and angioplasty use for stenosis and patency management, according to Strategic Market Research.

 

The Arteriovenous Fistula Devices Market includes products used either to create a controlled fistula for hemodialysis or to close an abnormal connection between an artery and a vein. This distinction defines the market’s two primary revenue streams.

 

The dialysis-access segment includes surgical and percutaneous fistula-creation systems, angioplasty balloons, drug-coated balloons, thrombectomy devices, covered stents and access-support products. The pathological AVF segment includes vascular plugs, embolization coils, liquid embolic agents, covered stents and surgical repair products used to close congenital or acquired fistulas.

 

AVFs can occur in the coronary circulation, dura and pial vessels of the brain, peripheral vessels in the arms or legs, renal vasculature and spinal dura. Peripheral AVFs also include deliberately created hemodialysis fistulas and fistulas caused by trauma, surgery or catheter-based procedures.

 

These use cases require different devices. A dialysis AVF must remain open and deliver sufficient blood flow. A cerebral, coronary, renal, spinal or traumatic AVF usually must be closed because the abnormal blood flow can cause bleeding, cardiac overload, venous hypertension, neurological injury or loss of organ function.

 

Duplex ultrasound, angiography and magnetic resonance angiography determine vessel size, flow pattern and fistula location before treatment. Imaging supports device selection, but it is not the primary commercial focus of the AVF device market. Revenue is concentrated in the catheter, plug, coil, embolic agent, balloon, stent or surgical product used to create or close the connection.

 

Major Companies and Devices Used in AVF Treatment

BD participates in both AVF creation and dialysis-access maintenance. Its WavelinQ EndoAVF System is used to create an arteriovenous fistula percutaneously in eligible hemodialysis patients. The company also supplies the Lutonix 035 Drug-Coated Balloon and Covera Vascular Covered Stent for treating stenosis and recurrent dysfunction within dialysis-access circuits. This product range allows BD to participate in the initial creation procedure and in subsequent interventions required to maintain access patency.

Ellipsys Medical supplies the Ellipsys Vascular Access System, which uses ultrasound guidance to create a percutaneous dialysis AVF. The system is positioned as an alternative to conventional surgical creation for patients with suitable vascular anatomy. Its commercial adoption depends on physician training, anatomical eligibility and the number of additional procedures required before the fistula becomes usable for dialysis.

Medtronic’s main position in the dialysis AVF segment is the IN.PACT AV Drug-Coated Balloon. The device delivers paclitaxel to stenotic lesions in native AVFs after angioplasty. Its commercial value lies in extending lesion patency and reducing the frequency of repeat interventions compared with standard balloon angioplasty. Medtronic also supplies the Onyx Liquid Embolic System for neurovascular embolization, including the treatment of complex fistulous vascular lesions selected by neurointerventional specialists.

Merit Medical competes in dialysis-access preservation through the WRAPSODY Cell-Impermeable Endoprosthesis. The covered implant is used to treat stenosis or occlusion in the venous outflow circuit of an AVF and at the venous anastomosis of an arteriovenous graft. WRAPSODY targets patients with recurrent or resistant lesions where repeated balloon angioplasty may not provide sufficient durability.

Abbott supplies the Amplatzer Vascular Plug family for the embolization of high-flow fistulas in peripheral vessels, coronary circulation and organ-based vasculature. These nitinol devices are designed to reduce or stop blood flow through an abnormal connection. Vascular plugs are particularly relevant when the fistulous tract is large enough to accommodate a delivery catheter and when coil migration could be a concern.

Penumbra participates in peripheral AVF embolization through the Ruby, POD and Ruby XL coil systems. These detachable coils are used to mechanically occlude abnormal vascular connections and high-flow vessels. The larger Ruby XL platform is intended to increase embolic volume per implant, which may reduce the number of coils required in selected procedures and shorten treatment time.

Terumo Neuro, through MicroVention, supplies the PHIL Liquid Embolic System for the endovascular treatment of intracranial dural AVFs. The liquid material travels through a microcatheter and solidifies within the abnormal vascular connection. MicroVention also offers the AZUR HydroCoil and AZUR CX systems for peripheral embolization. These coil platforms are used in AVFs and other vascular abnormalities where controlled occlusion and high packing density are required.

Boston Scientific’s Interlock Fibered IDC Occlusion System is used for coil embolization in peripheral vessels and selected coronary fistulas. The detachable design allows the physician to assess coil position before final release, which is important in tortuous anatomy or near critical vessel branches.

W. L. Gore & Associates supplies the VIABAHN Endoprosthesis for the exclusion of selected peripheral vascular injuries and dialysis-access lesions. The covered stent preserves blood flow through the parent vessel while isolating the fistulous opening or damaged vascular segment. Its use depends on the availability of an adequate landing zone and the need to preserve nearby arterial branches.

The AVF device market remains fragmented because no single product can create, repair or close every type of fistula. Dialysis AVFs require devices that establish and preserve high blood flow, while coronary, cerebral, renal, spinal and traumatic AVFs usually require embolization or exclusion. Device selection therefore depends on the fistula’s location, vessel diameter, flow rate, tortuosity, number of feeding vessels and accessibility. Companies with creation, angioplasty, embolization and covered-stent products can capture revenue across several treatment stages, while specialised suppliers compete through better deliverability, occlusion control or longer access patency.

 

Dialysis AVFs Represent the Largest Recurring Device Use Case

A hemodialysis AVF is created intentionally, generally in the arm, to provide repeated vascular access. Most are created surgically, but BD’s WavelinQ and the Ellipsys system allow selected patients to receive a catheter-based fistula without a conventional open anastomosis.

WavelinQ uses paired arterial and venous catheters. Magnets align the devices before radiofrequency energy creates the connection. Ellipsys uses one ultrasound-guided catheter to join the proximal radial artery with an adjacent perforating vein. Both systems move part of AVF creation from the operating room into interventional radiology or vascular-access laboratories.

The United States had 516,837 dialysis patients as of March 31, 2025, including 433,396 receiving in-centre hemodialysis. This population forms the addressable base for AVF creation, maturation and maintenance products.

A Society for Vascular Surgery registry recorded 52,170 first-time hemodialysis access creations between 2012 and 2022. AVFs accounted for 83.1% of those procedures, including 57.9% created in the upper arm and 25.2% in the forearm. The dataset represents participating centres rather than every US procedure, but it confirms that native fistulas remain the dominant first-access choice.

The more commercially important figure is the number of fistulas that need additional treatment. A Medicare study analysed 45,087 AVFs placed in 39,820 hemodialysis patients. No subsequent use was identified for 36.2% of the fistulas, while only 54.7% were used within four months. This creates demand for balloon-assisted maturation, embolization of competing veins, ultrasound-guided revision and replacement access.

AVF creation therefore does not produce only one device sale. The same patient may require a creation catheter, embolization coils, several angioplasty balloons and later a thrombectomy or covered stent. Suppliers with products across the access lifecycle can generate more revenue per patient than companies selling only a fistula-creation system.

 

Angioplasty and Drug-Coated Balloons Generate Repeat Dialysis-Access Revenue

Stenosis is one of the most common causes of dialysis AVF dysfunction. Conventional and high-pressure angioplasty balloons remain the most widely used endovascular devices because they are the first treatment for clinically significant narrowing.

Medtronic’s IN.PACT AV and BD’s Lutonix 035 add paclitaxel to the balloon surface. The drug is delivered locally after the lesion has been mechanically expanded. It is intended to limit the tissue growth that causes restenosis.

In the IN.PACT AV randomised trial, six-month target-lesion primary patency reached 82.2% with the paclitaxel-coated balloon, compared with 59.5% following standard angioplasty. The commercial value lies in reducing the frequency of repeat procedures rather than permanently curing access disease.

Paclitaxel is currently the most established drug used in approved AVF devices. There is no approved systemic medication that reliably causes a fistula to mature or permanently prevents AVF stenosis. Drug development is therefore concentrated in local device-based delivery.

Concept Medical is developing the MagicTouch AVF sirolimus-coated balloon as an alternative to paclitaxel. Sirolimus could create a new competitive category, but adoption will depend on comparative patency and reintervention evidence. Hospitals are unlikely to replace established DCB contracts solely because a product uses a different drug.

 

Covered Stents Target Recurrent Dialysis-Access Failure

Covered stents are used when balloon angioplasty does not provide adequate durability, when a vessel ruptures or when recurrent venous outflow disease threatens the fistula.

Merit Medical received FDA approval for the WRAPSODY Cell-Impermeable Endoprosthesis in December 2024. The device is indicated for stenosis or occlusion in the peripheral veins of a dialysis AVF and at the venous anastomosis of an AV graft.

WRAPSODY was one of the few AVF devices with a company-specific 2025 revenue disclosure. Merit lowered its expected US revenue for the year to approximately USD 2 million to USD 4 million after outpatient reimbursement advanced more slowly than expected. The company did not disclose unit sales.

Regulatory approval did not lead to immediate adoption. Dialysis-access procedures are commonly performed in outpatient hospitals, ambulatory centres, and office-based laboratories, where inadequate reimbursement can restrict the use of premium implants.

BD competes in this segment through the Covera Vascular Covered Stent, while Gore participates in dialysis-access and peripheral-vessel applications through its endoprosthesis portfolio. Competition is based on patency, flexibility, sizing range and reimbursement rather than the ability to technically open a vessel.

 

Intracranial Dural AVFs Are Becoming a Dedicated Liquid-Embolic Market

Dural AVFs are abnormal connections between arteries supplying the dura and dural veins or venous sinuses. They account for an estimated 10% to 15% of intracranial vascular malformations and have a reported annual incidence of approximately 0.15 to 0.29 cases per 100,000 people.

Although the patient population is small, these procedures use high-value liquid embolics, microcatheters, balloon microcatheters and detachable coils. Endovascular embolization has become the primary treatment for many intracranial dAVFs because it can close the fistulous connection without open cranial surgery.

Medtronic’s Onyx has been an established non-adhesive liquid embolic platform in neurovascular intervention. MicroVention, part of Terumo, introduced a direct competitive challenge through the PHIL Liquid Embolic System.

The FDA approved PHIL under a Humanitarian Device Exemption on December 31, 2025, specifically for intracranial dural AVFs. The approval is commercially significant because FDA stated that no comparable liquid embolic device was then available in the United States with an indication specifically covering intracranial dAVF treatment.

PHIL is available in 25%, 30% and 35% formulations. Lower-viscosity PHIL 25% is intended to penetrate more distally, while PHIL 35% is suited to larger or higher-flow fistulous components. The different formulations allow MicroVention to compete through procedure-specific product selection rather than a single embolic viscosity.

The FDA submission included 64 patients treated with PHIL, of whom 62 had primary endpoint data. Target-vessel occlusion after the first treatment was achieved in 60 of 62 patients under the FDA’s worst-case analysis. Fifty-five patients, or 88.7%, required one PHIL procedure. Six required two procedures and one required three. Additional coils or another liquid embolic were used in 12.9% of patients.

PHIL therefore does not remove demand for coils or supporting microcatheters. It expands the available embolic portfolio and may shift some US dAVF procedures away from products used without a specific dAVF indication.

 

Coronary AVFs Create a Small but High-Value Occlusion-Device Segment

Coronary artery fistulas are abnormal connections between a coronary artery and a cardiac chamber, pulmonary vessel, systemic vein, or another vascular structure. They may be congenital or develop after surgery, biopsy, or another cardiovascular procedure.

Angiographic studies have identified coronary fistulas in approximately 0.02% to 0.87% of examined patients. Differences in imaging methods and the inclusion of small incidental fistulas account for the wide range.

There is no dedicated device designed exclusively for coronary fistula closure. Interventional cardiologists use vascular plugs, detachable coils and patent ductus arteriosus occluders according to fistula anatomy.

Abbott’s Amplatzer Vascular Plug family is commercially important in large or high-flow fistulas because a plug can sometimes close the tract with one implant. The nitinol mesh creates a physical barrier and promotes thrombosis. Abbott indicates the devices for therapeutic embolization to reduce or obstruct blood flow in the peripheral vasculature.

Smaller or highly tortuous coronary fistulas are more likely to be treated with coils because a microcatheter can reach vessels that are unsuitable for a larger plug-delivery sheath. Boston Scientific’s Interlock coils and other detachable coil systems participate in these procedures.

A 2025 study examined 101 coronary fistula closures performed between 2011 and 2022. Sixty-six patients received patent ductus arteriosus occluders and 35 received coils. Acute procedural success reached 87.9% with occluders, compared with 62.9% for coils. Coils were used more often in fistulas with multiple origins or drainage points, while occluders were preferred for large and aneurysmal fistulas.

The results show why one product category cannot dominate coronary AVF treatment. Occluders can provide more reliable closure in large tracts, but coils remain necessary in small, branched or tortuous anatomy. Device companies compete on deliverability and sizing rather than treatment volume, which remains low compared with dialysis access.

 

Peripheral AVFs Support Demand for Plugs, Coils and Covered Stents

Peripheral AVFs can develop after penetrating trauma, fractures, vascular surgery, catheterisation or other interventions. The treatment objective is to stop abnormal flow while preserving circulation to the limb or affected organ.

Abbott’s Amplatzer Vascular Plugs are used when the feeding vessel is large enough for a delivery catheter and rapid mechanical occlusion is required. Plugs are particularly useful in high-flow fistulas where small coils could migrate through the connection.

Penumbra’s Ruby and POD platforms provide detachable coils for arterial and venous embolization in the peripheral vasculature. Detachability allows the physician to reposition the coil before release, reducing the risk of non-target embolization.

Penumbra launched the Ruby XL System in the United States in June 2025 after FDA clearance. The platform includes Ruby XL, POD XL and Packing Coil XL. The coils are available in sizes up to 40 millimetres and lengths up to 70 centimetres. Penumbra is positioning the platform for large and high-flow vessels where one higher-volume coil could replace several smaller coils.

That product design has a direct purchasing implication. Fewer coils per procedure may reduce procedure time and radiation exposure, but it can also lower the number of units used. Penumbra must therefore defend premium pricing by demonstrating that the total procedure cost is lower despite fewer implants.

Terumo’s AZUR HydroCoil systems compete by using hydrogel that expands after implantation. The expansion fills spaces between coil loops and increases packing density. The platform is indicated in relevant markets for interventional management of peripheral arteriovenous fistulas, arteriovenous malformations, aneurysms and other vascular lesions.

Covered stents offer another option when the anatomy permits exclusion of the fistulous opening while maintaining flow through the parent artery. This approach is commercially relevant in larger peripheral vessels but is less suitable near critical branches or in highly tortuous anatomy.

 

Renal AVFs Create Selective Embolization Demand Rather Than High Procedure Volume

Renal AVFs may be congenital, traumatic or acquired after kidney biopsy, transplantation or surgery. Many small post-biopsy fistulas close without treatment, which limits the addressable device population.

A transplant-biopsy study reported AVFs in 8.3% of patients and found that 77% resolved spontaneously. Device treatment is generally reserved for persistent haematuria, falling haemoglobin, enlarging fistulas, impaired kidney function or high-output cardiac effects.

Selective renal-artery embolization uses microcoils, vascular plugs, liquid embolics or particles to close the feeding artery while preserving as much renal tissue as possible. Abbott, Penumbra, Terumo and Boston Scientific participate through their embolization portfolios.

The commercial opportunity is therefore procedure-selective. Higher detection after biopsy does not automatically translate into equivalent device sales because most small renal AVFs are monitored rather than embolized.

 

Spinal Dural AVFs Remain More Surgically Oriented

Spinal dural AVFs are rare, with an estimated annual incidence of five to ten cases per million people. They account for approximately 70% to 80% of spinal vascular malformations.

Treatment can involve endovascular embolization or surgical disconnection. Surgery retains a stronger position than in intracranial dAVFs because durable closure often requires interruption of the draining vein.

A 2024 study evaluated 81 treated spinal dAVF patients. Seventy patients, or 86.4%, received surgery, while only 11 underwent endovascular treatment. Six patients required additional treatment after incomplete or failed occlusion.

This treatment mix limits the immediate market for liquid embolics in spinal disease. The FDA’s 2025 PHIL approval covers intracranial dAVFs but excludes spinal dAVFs because the submitted data did not adequately support the spinal indication.

Surgical clips, microsurgical instruments and intraoperative imaging therefore remain more commercially important in spinal dAVF treatment than liquid embolic systems.

 

Medication and Radiation Have Limited Influence on AVF Device Revenue

Medication does not close an established AVF. Anticoagulants or antiplatelet drugs may be used in selected patients to manage thrombosis risk, maintain another vascular device or treat an unrelated cardiovascular condition. Their use depends on bleeding risk and fistula location.

Thrombolytic drugs such as alteplase can be used during declotting of a thrombosed dialysis AVF, but the procedure remains device-led because the clot must be removed and the causative stenosis usually requires angioplasty.

Stereotactic radiosurgery may be considered for selected intracranial fistulas that cannot be completely treated by embolization or surgery. Its effect is delayed because the abnormal vessels close gradually. It therefore has a smaller role in urgent or high-risk fistulas and does not compete directly with immediate mechanical occlusion.

There is no major systemic-drug pipeline dedicated to AVF closure. Innovation is concentrated in liquid embolics, high-volume coils, vascular plugs, covered implants and improved catheter-delivery systems.

 

New Devices Are Expanding Competition in Both AVF Creation and Closure

The December 2025 FDA approval of PHIL creates the clearest recent change in pathological AVF treatment. MicroVention now has a liquid embolic specifically indicated for intracranial dAVFs in the United States. The approval gives Terumo a stronger position against established neurovascular embolization suppliers and creates follow-on demand for compatible Headway and Scepter microcatheters.

Penumbra’s 2025 Ruby XL launch extends detachable coil treatment into larger and higher-flow vessels. The system competes with vascular plugs and multi-coil procedures by offering greater embolic volume from a single implant.

Venova Medical is developing the Velocity system as a new percutaneous dialysis-AVF creation platform. Its VENOS-3 pivotal programme is designed to enrol up to 126 US patients and support a future FDA application. The product would compete with WavelinQ, Ellipsys and surgical creation.

Ellipsys Medical is preparing to return the Ellipsys creation system to the market after Medtronic discontinued commercialisation in 2025. Re-entry may restore competition in centres already trained on the platform, but continuity of supply and physician support will be as important as technical performance.

WRAPSODY is expanding the premium covered-stent segment in dialysis access, although its slower-than-expected 2025 revenue ramp shows that reimbursement remains a decisive adoption barrier.

 

Competitive Positioning Is Moving Toward Procedure-Specific Portfolios

BD has the broadest position in dialysis AVF devices through WavelinQ creation, Lutonix balloon treatment and Covera covered-stent therapy. The portfolio allows BD to participate before the fistula is used and again when stenosis develops.

Medtronic has reduced its exposure to AVF creation after leaving Ellipsys commercialisation but retains a strong position in dialysis-access maintenance through IN.PACT AV. It also participates in neurovascular embolization through Onyx.

Terumo combines peripheral coils, neurovascular microcatheters and MicroVention’s PHIL system. PHIL’s new US dAVF indication gives the company a differentiated position in a small but high-value treatment category.

Abbott’s strength lies in vascular plugs that can close large and high-flow fistulas in a single implant. Penumbra and Boston Scientific compete more heavily in coil-based embolization, where multiple sizes and controlled deployment are critical.

Merit Medical is attempting to capture higher revenue per dialysis-access procedure through WRAPSODY. Its experience shows that premium pricing must be aligned with reimbursement and site-of-care economics.

The market will not be led by one universal AVF device. Dialysis fistulas require products that create and preserve blood flow. Pathological fistulas require products that permanently stop it. Companies that cover several anatomies and treatment stages are better positioned to capture complete procedural revenue, but specialised products can gain share when they reduce the number of implants, improve occlusion or avoid repeat intervention.

 

Arteriovenous Fistula Devices Market Report Coverage Table

Report Attribute	Details
Forecast Period	2026 – 2032
Market Size Value in 2025	USD 1.03 Billion
Revenue Forecast in 2032	USD 1.76 Billion
Overall Growth Rate	CAGR of 7.9% (2026 – 2032)
Base Year for Estimation	2025
Historical Data	2019 – 2024
Unit	USD Million, CAGR (2026 – 2032)
Segmentation	By Product Type, By Application, By End User, By Geography
By Product Type	AVF Creation Devices, AVF Maintenance Devices
By Application	Hemodialysis Access, Pediatric Renal Care, Clinical Trials
By End User	Hospitals, Outpatient Dialysis Clinics, ASCs, Research Institutes
By Region	North America, Europe, Asia-Pacific, Latin America, Middle East & Africa
Country Scope	U.S., UK, Germany, China, India, Japan, Brazil, etc.
Market Drivers	- Rise in CKD and ESRD cases globally - Innovation in minimally invasive AVF procedures - Value-based care and reduction in catheter-related infections
Customization Option	Available upon request