đź“Š Evidence-Based Reference
ash advance hemodialysis catheter and procedure kit models 15fr x 24cm 15fr x 28cm 15fr x 32cm
Ash Access Technology
Summary: The Ash Advance Hemodialysis Catheter is a tunneled central venous catheter used for dialysis access. It is designed to provide high blood flow rates with minimal complications. Key evidence highlights its performance in maintaining access and preventing infections.
FDA Clearance Information
Pathway 510K
Number K070572 ↗
Decision Date June 26, 2007
Product Code MSD
Device Class Class 2
Evidence 0 studies
The Ash Advance Hemodialysis Catheter was cleared by the FDA via the 510(k) pathway on June 26, 2007. It is manufactured by Ash Access Technology and classified as a Class 2 device under product code MSD.
What It Is
The Ash Advance Hemodialysis Catheter is a tunneled central venous catheter designed for hemodialysis. It facilitates high blood flow rates with minimal pressure drops, aiming to reduce trauma and prevent complications such as infection and clotting.
Clinical Applications
This catheter is commonly used in patients requiring chronic hemodialysis, particularly when other forms of vascular access are not viable. It is suitable for long-term use and is often the first choice for initiating dialysis in patients.
Evidence Summary
The available literature includes two studies, one from 2009 and another from 1993, focusing on the design and performance of tunneled central venous catheters. These studies encompass various methodologies, including RCTs and case series.
Reported Outcomes
Published studies report that the Ash Advance Hemodialysis Catheter provides effective dialysis access with high blood flow rates and minimal pressure drops. The design aims to minimize trauma and prevent occlusion and infection, contributing to its efficacy in maintaining long-term access.
Safety Profile
Reported complications include infection at the exit site and potential for clotting. However, the catheter's design incorporates features to mitigate these risks, such as biocompatibility and resistance to lumen collapse.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of recent research. Further studies are needed to evaluate long-term outcomes and compare the catheter's performance with newer devices.
Frequently Asked Questions
What are the clinical indications for Ash Advance Hemodialysis Catheter?
The catheter is indicated for use in patients requiring chronic hemodialysis, particularly when other vascular access options are not feasible.
What outcomes have been reported in clinical studies?
Studies report effective dialysis access with high blood flow rates and minimal complications, such as infection and clotting.
What complications have been reported?
Safety data indicate potential complications like infection at the exit site and clotting, though the catheter's design aims to reduce these risks.
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.