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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 ?
510(k)
Number ?
K070572 ↗
Decision Date ?
June 26, 2007
Product Code ?
MSD Catheter, Hemodialysis, Implanted
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.
FDA-Cleared Indications
- Vascular access for hemodialysis in patients with renal failure.
- Placement in a central vein to provide access for extracorporeal blood circulation during dialysis.
- Use when an appropriate arteriovenous fistula or graft is not available, cannot be used, or is not yet ready.
Clinical Applications
- Tunneled central venous access for chronic hemodialysis.
- Hemodialysis access while an arteriovenous fistula or graft matures.
- Hemodialysis access when permanent surgical access is unsuitable or unavailable.
- Catheter-based blood withdrawal and return during dialysis treatments.
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.
Practical Considerations
- Available listed sizes are 15 French by 24 cm, 28 cm, and 32 cm; the appropriate length depends on the insertion site, patient anatomy, and final tip position.
- Placement is generally performed through a central vein, commonly the internal jugular vein, with ultrasound and fluoroscopic or other imaging guidance.
- The catheter requires sterile handling and routine locking, flushing, dressing changes, and monitoring for infection, thrombosis, malfunction, bleeding, and central venous stenosis.
- MRI compatibility should be confirmed in the current manufacturer instructions for use and facility policy before scanning; MRI conditions may vary by catheter components and configuration.
- Contraindications and precautions include local or systemic infection, uncorrected bleeding risk, thrombosis or occlusion of the intended vein, and inability to safely access or position the catheter.
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.