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AngioDynamics Inc Duramax Hemodialysis Catheter and Procedure Kit
Summary: The DuraMax Hemodialysis Catheter by Angiodynamics is a device used for vascular access in hemodialysis. It is FDA 510k cleared and has been evaluated in two clinical studies, focusing on its efficacy and safety compared to other dialysis catheters.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K080400 ↗
Decision Date ?
May 13, 2008
Product Code ?
MSD Catheter, Hemodialysis, Implanted
Device Class ?
Class 2
Evidence ?
0 studies
The DuraMax Hemodialysis Catheter was cleared by the FDA through the 510k pathway on May 13, 2008. It is manufactured by Angiodynamics and classified as a Class 2 device under product code MSD.
What It Is
The DuraMax Hemodialysis Catheter is a vascular access device designed for use in hemodialysis. It facilitates efficient blood flow and is intended for patients requiring dialysis treatment.
FDA-Cleared Indications
- Vascular access for hemodialysis.
- Use in patients who require hemodialysis and need catheter-based central venous access.
- Placement through a central vein to support extracorporeal blood circulation during dialysis.
Clinical Applications
- Central venous access for hemodialysis.
- Hemodialysis access when an arteriovenous fistula or graft is not available, usable, or ready.
- Catheter-based dialysis access during treatment of acute or chronic kidney failure, when clinically indicated.
- Image-guided placement of a hemodialysis catheter in a central vein.
Evidence Summary
The available literature includes two clinical studies registered on ClinicalTrials.gov. These studies aim to compare the DuraMax catheter with other dialysis catheters, although specific outcomes and safety data are not detailed in the provided abstracts.
Reported Outcomes
Published studies report comparisons between the DuraMax catheter and other dialysis catheters, such as the Palindrome. However, specific efficacy findings, such as flow rates or patient outcomes, are not detailed in the available evidence.
Safety Profile
Reported complications include general risks associated with catheter use, such as infection and thrombosis. However, specific safety data from the studies are not provided in the available abstracts.
Evidence Limitations
The evidence is limited by the lack of detailed outcomes and safety data in the available study abstracts. Further research is needed to provide comprehensive efficacy and safety profiles for the DuraMax catheter.
Practical Considerations
- The specific catheter configuration and available sizes should be confirmed in the current product labeling and facility inventory; dialysis catheters are selected according to the required blood-flow rate, patient anatomy, and anticipated duration of use.
- Common access sites include the internal jugular, femoral, and subclavian veins. The right internal jugular vein is often preferred when suitable; subclavian access may be avoided when it could compromise future arteriovenous access.
- Placement is generally performed with ultrasound and fluoroscopic or radiographic guidance, using local anesthesia with or without moderate sedation depending on the patient and setting.
- The catheter must be maintained with sterile technique and an appropriate locking solution according to institutional protocol and labeling. Infection, thrombosis, malposition, bleeding, and central venous stenosis are important risks.
- MRI compatibility is configuration-specific. Confirm the exact catheter model and current manufacturer MRI labeling before an MRI examination; the kit's guidewires, dilators, and other components may have separate safety requirements.
Frequently Asked Questions
What are the clinical indications for DuraMax Hemodialysis Catheter?
The DuraMax Hemodialysis Catheter is indicated for use in patients requiring vascular access for hemodialysis.
What outcomes have been reported in clinical studies?
Specific outcomes from the studies are not detailed in the available evidence, but they focus on comparing the DuraMax catheter with other dialysis catheters.
What complications have been reported?
Safety data from the evidence indicate general risks such as infection and thrombosis, but specific complications are not detailed.
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.