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Duramax Chronic Hemodialysis Catheter and Procedure Kit
Product: DuraMax — all models and sizes
Summary: The DuraMax Chronic Hemodialysis Catheter by Angiodynamics is designed for long-term hemodialysis access. It is FDA-cleared and primarily used in patients requiring chronic dialysis. Limited evidence from two studies is available, focusing on device comparison and dialysis outcomes.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K101843 ↗
Decision Date ?
October 20, 2010
Product Code ?
MSD Catheter, Hemodialysis, Implanted
Device Class ?
Class 2
Evidence ?
0 studies
The DuraMax Chronic Hemodialysis Catheter was cleared by the FDA via the 510(k) pathway on October 20, 2010. It is manufactured by Angiodynamics and classified as a Class 2 device under product code MSD.
What It Is
The DuraMax Chronic Hemodialysis Catheter is a medical device intended for providing vascular access for hemodialysis in patients with chronic kidney disease. It facilitates efficient blood flow during dialysis sessions.
FDA-Cleared Indications
- Vascular access for hemodialysis in patients requiring chronic hemodialysis.
- Use as a tunneled, long-term central venous access catheter for dialysis blood withdrawal and return.
Clinical Applications
- Providing access for repeated chronic hemodialysis treatments.
- Connecting a patient to the extracorporeal dialysis circuit for blood removal and return.
- Use when an arteriovenous fistula or graft is not available, cannot be used, or has failed.
- Placement through a central vein, commonly the internal jugular vein, for tunneled dialysis access.
Evidence Summary
The available literature includes two studies registered on ClinicalTrials.gov. These studies focus on dialysis access and compare the DuraMax catheter with other devices. However, detailed outcomes and safety data are not provided.
Reported Outcomes
Published studies report limited data on the efficacy of the DuraMax catheter. The studies primarily focus on comparing dialysis access outcomes between different catheter types, but specific efficacy metrics are not detailed.
Safety Profile
Reported complications include general catheter-related issues such as infection and thrombosis, although specific safety data from the studies are not detailed. Further research is needed to comprehensively assess safety.
Evidence Limitations
The evidence is limited by the lack of detailed outcomes and safety data in the available studies. Further research is needed to evaluate long-term efficacy and safety, as well as to compare the DuraMax catheter with other dialysis access devices.
Practical Considerations
- The catheter is available in different configurations and lengths; selection depends on the access vein, patient anatomy, and desired tip location.
- Placement is typically performed using ultrasound and fluoroscopic imaging, with local anesthesia and sedation when appropriate.
- The catheter must be flushed, locked, dressed, and accessed according to the manufacturer’s instructions and the dialysis program’s protocol.
- MRI safety and conditions depend on the exact catheter and kit labeling; verify the product-specific MRI status before scanning.
- Potential complications include infection, thrombosis, bleeding, catheter dysfunction, vessel injury, malposition, and central venous stenosis.
Frequently Asked Questions
What are the clinical indications for DuraMax Chronic Hemodialysis Catheter?
The DuraMax catheter is indicated for providing vascular access for long-term hemodialysis in patients with chronic kidney disease.
What outcomes have been reported in clinical studies?
The studies focus on dialysis access outcomes, but specific findings on efficacy are not detailed in the available evidence.
What complications have been reported?
Safety data from the studies are limited, but general complications such as infection and thrombosis are associated with catheter use.
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.