đź“Š Evidence-Based Reference
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 ?
510(k)
Number ?
K141124 ↗
Decision Date ?
May 30, 2014
Product Code ?
DSY Prosthesis, Vascular Graft, Of 6Mm And Greater Diameter
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.
FDA-Cleared Indications
- For use as a vascular prosthesis to create an arteriovenous access for hemodialysis.
- For patients who require vascular access for extracorporeal blood circulation during hemodialysis.
- Intended for use as a large-diameter vascular graft, consistent with FDA product code DSY and 21 CFR 870.3450.
Clinical Applications
- Creation of a prosthetic arteriovenous graft for hemodialysis access.
- Connection of an artery and vein when a native arteriovenous fistula is not suitable or cannot be created.
- Use as a cannulatable conduit for repeated hemodialysis treatments.
- Use in the upper or lower extremity when selected by the vascular access team based on the patient's anatomy.
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.
Practical Considerations
- The graft is intended for large-diameter vascular reconstruction and should be selected in a size and configuration compatible with the patient's vessels and the planned access circuit.
- Implantation requires surgical exposure and vascular anastomoses; the graft should be handled according to the manufacturer's instructions to avoid kinking, twisting, compression, or damage.
- Potential complications include thrombosis, infection, stenosis at the anastomoses, bleeding, steal syndrome, venous hypertension, and failure of access maturation or function.
- MRI safety depends on the specific graft construction and labeling. The exact product instructions and current MRI conditions should be reviewed before scanning; the device should not be assumed to be MRI safe without verification.
- Patients require ongoing examination and access surveillance, including assessment of the thrill and bruit and evaluation of abnormal bleeding, swelling, pain, reduced dialysis flow, or loss of access function.
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.