đź“Š Evidence-Based Reference
Arteriovenous Fistula Sets
Baxter Healthcare
Summary: Arteriovenous fistula sets are used for creating vascular access in hemodialysis patients. Key evidence highlights risk prediction models for stenosis and failure factors.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K900125 ↗
Decision Date ?
January 31, 1990
Product Code ?
FIE
Device Class ?
Class 2
Evidence ?
0 studies
The arteriovenous fistula sets by Baxter Healthcare were cleared through the FDA 510(k) pathway on January 31, 1990. They are classified as Class 2 devices.
What It Is
Arteriovenous fistula sets are medical devices used to create a connection between an artery and a vein, facilitating vascular access for hemodialysis. They are intended for patients requiring long-term dialysis treatment.
FDA-Cleared Indications
- Creation of an arteriovenous fistula for vascular access in patients receiving hemodialysis.
- Establishment of vascular access intended for repeated hemodialysis treatments.
Clinical Applications
- Creating an arteriovenous connection for long-term hemodialysis access.
- Providing access for repeated blood removal and return during maintenance hemodialysis.
- Supporting an alternative to prolonged use of a central venous dialysis catheter when clinically appropriate.
Evidence Summary
The literature includes 14 studies, comprising various study types such as RCTs, prospective, and retrospective analyses. The studies span from 2021 to 2025, focusing on risk prediction and failure factors.
Reported Outcomes
Published studies report the development of machine learning models for predicting stenosis risk and nomogram models for assessing failure factors in arteriovenous fistulas. These models aim to improve clinical decision-making and patient outcomes.
Safety Profile
Reported complications include stenosis and failure of the arteriovenous fistula, which can impact the quality of dialysis and patient prognosis. Safety data from the studies emphasize the need for predictive tools to mitigate these risks.
Evidence Limitations
The evidence highlights gaps in predictive accuracy and the need for further research to refine risk models. Limitations include the variability in study designs and the need for larger, more diverse patient populations.
Practical Considerations
- The set must be selected and used according to its labeling, configuration, and the patient's vessel size and anatomy.
- The access requires assessment of arterial inflow, venous outflow, and suitability for repeated dialysis cannulation.
- Strict sterile technique is required because infection can threaten the access and the patient's health.
- MRI safety depends on the materials and components of the specific set; verify the manufacturer's current labeling before MRI.
- Potential complications include bleeding, thrombosis, infection, stenosis, inadequate blood flow, steal syndrome, and access failure.
Frequently Asked Questions
What are the clinical indications for arteriovenous fistula sets?
Arteriovenous fistula sets are indicated for patients requiring long-term vascular access for hemodialysis.
What outcomes have been reported in clinical studies?
Studies report the development of predictive models for stenosis and failure, aiming to enhance clinical decision-making.
What complications have been reported?
Safety data indicate complications such as stenosis and failure of the arteriovenous fistula, affecting dialysis quality.
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.