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spiral laminar flow vascular arteriovenous graft
Tayside Flow Technologies
Summary: The spiral laminar flow vascular arteriovenous graft by Tayside Flow Technologies is used primarily for dialysis access. Key evidence suggests it may reduce disturbed shear and intimal hyperplasia.
FDA Clearance Information
Pathway
510K
Number
K094044 ↗
Decision Date
March 23, 2010
Product Code
DSY
Device Class
Class 2
Evidence
0 studies
The spiral laminar flow vascular arteriovenous graft was cleared by the FDA via the 510(k) pathway on March 23, 2010. It is manufactured by Tayside Flow Technologies and classified as a Class 2 device.
What It Is
The spiral laminar flow vascular arteriovenous graft is designed to create a helical flow pattern in the blood, which is intended to reduce disturbed shear and potentially decrease intimal hyperplasia. It is primarily used in dialysis access for patients requiring hemodialysis.
Clinical Applications
This device is commonly used in clinical scenarios requiring vascular access for hemodialysis, particularly in patients where traditional arteriovenous fistulas may not be viable or have failed.
Evidence Summary
The available literature includes 6 studies, with a mix of RCTs, prospective, and retrospective designs, spanning from 2015 to 2025. These studies explore the effects of spiral laminar flow on vascular health and fistula maturation.
Reported Outcomes
Published studies report that spiral laminar flow is associated with a reduction in disturbed shear, which may protect against intimal hyperplasia. One study noted its potential as an early predictor for arteriovenous fistula maturation. However, specific quantitative outcomes were not detailed in the provided evidence.
Safety Profile
Reported complications include the potential for juxta-anastomotic stenosis, although the spiral laminar flow design aims to mitigate this risk. No specific adverse events were detailed in the provided studies.
Evidence Limitations
The evidence is limited by a lack of large-scale, long-term studies directly assessing clinical outcomes and safety. Further research is needed to confirm the efficacy and safety of spiral laminar flow in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for spiral laminar flow vascular arteriovenous graft?
The device is indicated for use in creating vascular access for hemodialysis, particularly in patients with challenging vascular anatomy or previous access failures.
What outcomes have been reported in clinical studies?
Studies suggest a reduction in disturbed shear and potential protection against intimal hyperplasia, with some evidence indicating it may predict fistula maturation.
What complications have been reported?
Reported complications include the risk of juxta-anastomotic stenosis, though the device's design aims to reduce this risk.
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.