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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 510K
Number K252277 ↗
Decision Date October 20, 2025
Product Code DSY
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.
Clinical Applications
This device is commonly used in patients requiring long-term hemodialysis access. It is particularly beneficial in scenarios where reducing vascular complications is critical, such as in patients with a history of arteriovenous fistula failure.
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.
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.