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duraspan hemodialysis long-term catheter
R4 Vascular
Summary: The Duraspan Hemodialysis Long-Term Catheter by R4 Vascular is designed for long-term vascular access in hemodialysis patients. Key evidence highlights its role in optimizing catheter tip position to reduce complications.
FDA Clearance Information
Pathway
510K
Number
K100169 ↗
Decision Date
February 18, 2010
Product Code
MSD
Device Class
Class 2
Evidence
0 studies
The Duraspan Hemodialysis Long-Term Catheter was cleared by the FDA via the 510k pathway on February 18, 2010. It is manufactured by R4 Vascular and classified as a Class 2 device under product code MSD.
What It Is
The Duraspan Hemodialysis Long-Term Catheter is a tunneled catheter used for providing vascular access in patients undergoing long-term hemodialysis. It is designed to facilitate efficient blood flow and minimize complications associated with dialysis access.
Clinical Applications
This catheter is commonly used in patients requiring long-term hemodialysis, particularly when other forms of vascular access are not viable. It is typically employed in dialysis centers and hospitals for patients with chronic kidney disease.
Evidence Summary
The available literature includes 10 studies, comprising retrospective and prospective analyses, narrative reviews, and guidelines, published between 2022 and 2025. These studies explore various aspects of catheter use, including tip position optimization and microbiota analysis.
Reported Outcomes
Published studies report that optimizing the catheter tip position can reduce catheter-related complications such as dysfunction and bloodstream infections. Microbiota studies have shown high detection rates of bacteria using metagenomic sequencing, indicating potential for predicting catheter-related infections.
Safety Profile
Reported complications include catheter-related bloodstream infections and dysfunction. The lack of consensus on catheter lock solutions highlights ongoing challenges in preventing these complications.
Evidence Limitations
Evidence gaps include a lack of consensus on catheter lock solutions and limited high-throughput research on catheter-related microbiota. Further research is needed to establish standardized protocols for preventing catheter-related complications.
Frequently Asked Questions
What are the clinical indications for Duraspan Hemodialysis Long-Term Catheter?
The catheter is indicated for providing long-term vascular access in patients undergoing hemodialysis.
What outcomes have been reported in clinical studies?
Studies report that optimizing catheter tip position can reduce complications such as dysfunction and bloodstream infections.
What complications have been reported?
Reported complications include catheter-related bloodstream infections and dysfunction, with ongoing challenges in prevention strategies.
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.