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spiral flow vascular arteriovenous graft
Vascular Flow Technologies
Summary: The spiral flow vascular arteriovenous graft is designed for hemodialysis access, promoting spiral laminar flow to reduce turbulence. Key evidence suggests improved hemodynamics compared to standard grafts.
FDA Clearance Information
Pathway 510K
Number K141124 ↗
Decision Date May 30, 2014
Product Code DSY
Device Class Class 2
Evidence 0 studies
The spiral flow vascular arteriovenous graft was cleared via the FDA 510(k) pathway on May 30, 2014. Manufactured by Vascular Flow Technologies, it is classified as a Class 2 device.
What It Is
The device is a vascular graft designed to create arteriovenous access for hemodialysis. It induces spiral laminar flow, aiming to reduce turbulence and improve patency rates by minimizing intimal hyperplasia.
Clinical Applications
Commonly used in patients requiring long-term hemodialysis, the graft is intended to provide reliable vascular access while reducing complications associated with traditional graft designs.
Evidence Summary
The literature includes 8 studies, with a mix of computational, in vitro, and animal model research, spanning from 2012 to 2019. These studies explore hemodynamic effects and potential clinical benefits.
Reported Outcomes
Published studies report that the spiral flow design may stabilize blood flow and reduce turbulence at the venous anastomosis. This could potentially lower the incidence of stenosis and improve graft patency compared to standard grafts.
Safety Profile
Reported complications include the potential for stenosis at the venous anastomosis, although the spiral design aims to mitigate this risk. No specific adverse events were detailed in the available studies.
Evidence Limitations
The evidence is primarily preclinical, with limited direct clinical trial data. Further research is needed to confirm long-term clinical outcomes and safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for spiral flow vascular arteriovenous graft?
The graft is indicated for patients requiring vascular access for hemodialysis, particularly those at risk of complications from traditional graft designs.
What outcomes have been reported in clinical studies?
Studies suggest improved hemodynamics and reduced turbulence, potentially lowering stenosis rates compared to standard grafts.
What complications have been reported?
Safety data indicate potential stenosis at the venous anastomosis, though the spiral 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.