đź“Š Evidence-Based Reference
Spiral Laminar Flow Vascular Arteriovenous Graft AV0645
Vascular Flow Technologies
Summary: The spiral laminar flow vascular arteriovenous graft AV0645 is designed for dialysis access, utilizing helical flow to reduce disturbed shear and intimal hyperplasia. Key evidence suggests potential benefits in reducing vascular complications.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K252277 ↗
Decision Date ?
October 20, 2025
Product Code ?
DSY Prosthesis, Vascular Graft, Of 6Mm And Greater Diameter
Device Class ?
Class 2
Evidence ?
0 studies
The device was cleared through the FDA 510(k) pathway on October 20, 2025, by Vascular Flow Technologies. It is classified as a Class 2 device under product code DSY.
What It Is
The spiral laminar flow vascular arteriovenous graft AV0645 is a medical device designed to facilitate hemodialysis access. It employs a unique helical flow mechanism to minimize disturbed shear stress, potentially reducing the risk of intimal hyperplasia.
FDA-Cleared Indications
- Use as a vascular prosthesis with a diameter of 6 mm or greater.
- Use to create an arteriovenous access for hemodialysis in patients with end-stage kidney disease.
- Use as a prosthetic conduit between an artery and vein when native arteriovenous fistula creation is not suitable or has failed.
Clinical Applications
- Creation of a prosthetic arteriovenous graft for hemodialysis access.
- Connection of a dialysis-access artery and vein in the upper or lower extremity.
- Hemodialysis access when a native arteriovenous fistula cannot be created or is inadequate.
- Revision or replacement of a failed or unusable prosthetic dialysis-access conduit, when consistent with the device labeling and surgical judgment.
Evidence Summary
The available literature includes five studies, ranging from 2015 to 2025, encompassing various study designs such as RCTs and retrospective analyses. These studies explore the efficacy of spiral laminar flow in reducing vascular complications.
Reported Outcomes
Published studies report that the spiral laminar flow mechanism is associated with a reduction in disturbed shear and intimal hyperplasia in arteriovenous fistulas. This may lead to improved patency rates and maturation of the fistula, enhancing the overall efficacy of hemodialysis access.
Safety Profile
Reported complications include potential risks associated with surgical implantation and the development of juxta-anastomotic stenosis. However, the spiral laminar flow design aims to mitigate these risks by promoting more stable hemodynamics.
Evidence Limitations
Current evidence is limited by the small sample sizes and the variability in study designs. Further research is needed to establish long-term outcomes and to validate the benefits of spiral laminar flow in diverse patient populations.
Practical Considerations
- The product code identifies this device category as a vascular graft of 6 mm or greater diameter; the exact available diameters, lengths and configurations should be confirmed in the manufacturer’s current instructions for use.
- Implantation requires surgical or endovascular planning, assessment of arterial inflow and venous outflow, and selection of an appropriate access configuration.
- The graft must be handled according to the instructions for use to avoid kinking, twisting, damage or contamination.
- MRI safety and conditions are device-specific and should be confirmed in the current labeling before MRI. Do not assume that a vascular graft is automatically MR safe or MR conditional.
- Potential complications include thrombosis, infection, bleeding, stenosis, pseudoaneurysm, steal syndrome and failure of dialysis access. Patient-specific contraindications and precautions are defined by the labeling and treating team.
Frequently Asked Questions
What are the clinical indications for spiral laminar flow vascular arteriovenous graft AV0645?
The device is indicated for use in patients requiring hemodialysis access, particularly those at risk for vascular complications such as intimal hyperplasia.
What outcomes have been reported in clinical studies?
Studies have reported a reduction in disturbed shear and intimal hyperplasia, potentially leading to improved patency and maturation rates of arteriovenous fistulas.
What complications have been reported?
Safety data indicate potential complications such as surgical risks and juxta-anastomotic stenosis, although the device's design aims to reduce these issues.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.