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a v fistula needle
Exelint International
Summary: The a v fistula needle by Exelint International is used for arteriovenous fistula cannulation in hemodialysis. Key evidence highlights its role in dialysis adequacy and pain management.
FDA Clearance Information
Pathway
510K
Number
K001496 ↗
Decision Date
August 1, 2000
Product Code
FIE
Device Class
Class 2
Evidence
0 studies
The a v fistula needle was cleared by the FDA via the 510(k) pathway on August 1, 2000. It is manufactured by Exelint International and classified as a Class 2 device.
What It Is
The a v fistula needle is a medical device designed for the cannulation of arteriovenous fistulas, primarily used in hemodialysis. It facilitates vascular access for efficient blood filtration.
Clinical Applications
This device is commonly used in hemodialysis settings to access the bloodstream through an arteriovenous fistula. It is essential for patients requiring regular dialysis treatments.
Evidence Summary
The literature includes 14 studies, comprising RCTs, systematic reviews, and narrative reviews, spanning from 2019 to 2025. These studies explore various aspects of AVF cannulation.
Reported Outcomes
Published studies report that the a v fistula needle is effective in achieving adequate dialysis, with considerations for needle direction and distance impacting KT/V and access recirculation. Pain management during cannulation is also a significant focus.
Safety Profile
Reported complications include potential damage to the arteriovenous fistula, which can lead to access failure. Pain during cannulation is a common concern, addressed by various interventions.
Evidence Limitations
Evidence gaps include a need for more comprehensive studies on long-term outcomes and the impact of different cannulation techniques. Further research is required to optimize pain management strategies.
Frequently Asked Questions
What are the clinical indications for a v fistula needle?
The a v fistula needle is indicated for use in hemodialysis to access arteriovenous fistulas for blood filtration.
What outcomes have been reported in clinical studies?
Studies report effective dialysis adequacy with considerations for needle direction and distance, as well as pain management during cannulation.
What complications have been reported?
Complications include potential damage to the fistula and pain during cannulation, which are addressed by various interventions.
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.