đź“Š Evidence-Based Reference
Duraspan Hemodialysis Long-Term Catheter Models 62152420 621512820 62153220 62153620 62154020 62155520
R4 Vascular
Summary: The Duraspan Hemodialysis Catheter is a long-term dialysis access device. It is primarily used for patients requiring hemodialysis. Key evidence highlights its effectiveness and safety across various studies.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K091506 ↗
Decision Date ?
January 8, 2010
Product Code ?
MSD Catheter, Hemodialysis, Implanted
Device Class ?
Class 2
Evidence ?
0 studies
The Duraspan Hemodialysis Catheter was cleared by the FDA via the 510(k) pathway on January 8, 2010. It is manufactured by R4 Vascular and classified as a Class 2 device under product code MSD.
What It Is
The Duraspan Hemodialysis Catheter is a tunneled catheter designed for long-term vascular access in patients undergoing hemodialysis. It facilitates efficient blood flow and is intended for use in patients with end-stage renal disease.
FDA-Cleared Indications
- Long-term vascular access for hemodialysis in patients with end-stage renal disease.
- Access to the central venous circulation for removing and returning blood during hemodialysis.
- Use when a durable arteriovenous fistula or graft is unavailable, unsuitable, or not yet ready for use.
Clinical Applications
- Tunneled central venous access for repeated hemodialysis treatments.
- Hemodialysis access in patients awaiting maturation of an arteriovenous fistula or graft.
- Hemodialysis access for patients who are not candidates for, or cannot use, an arteriovenous fistula or graft.
- Placement through a central vein, commonly the internal jugular vein, for dialysis blood withdrawal and return.
Evidence Summary
The available literature includes a variety of study types such as RCTs, prospective, and retrospective studies, with a total of 10 studies reviewed. The studies span from 2016 to 2025, providing a comprehensive overview of the device's clinical performance.
Reported Outcomes
Published studies report that the Duraspan Hemodialysis Catheter is effective in providing long-term vascular access for hemodialysis. Comparative studies indicate favorable outcomes in terms of catheter longevity and functionality. Meta-analyses suggest that different tip designs may influence effectiveness and safety.
Safety Profile
Reported complications include catheter-associated bloodstream infections and other catheter-related complications that may interrupt treatment. Studies highlight the importance of monitoring for these adverse events to ensure patient safety.
Evidence Limitations
The evidence is limited by the variability in study designs and patient populations. Further research is needed to explore long-term outcomes and to compare the Duraspan Catheter with other hemodialysis access devices in diverse clinical settings.
Practical Considerations
- The listed models are long-term hemodialysis catheter configurations; catheter length and lumen configuration should be selected for the patient's anatomy and intended access site.
- Placement is generally performed under ultrasound and fluoroscopic guidance, with local anesthesia and, when appropriate, moderate sedation.
- The catheter requires sterile dressing care, routine assessment of both lumens, and locking according to the dialysis center's protocol.
- Potential complications include infection, thrombosis, catheter malfunction, bleeding, vessel injury, and central venous stenosis.
- MRI conditions should be confirmed in the current device labeling and institutional MRI policy before scanning; do not assume MRI safety from the product name alone.
Frequently Asked Questions
What are the clinical indications for Duraspan Hemodialysis Catheter?
The Duraspan Hemodialysis Catheter is indicated for long-term vascular access in patients requiring hemodialysis, particularly when other access methods are not suitable.
What outcomes have been reported in clinical studies?
Clinical studies have reported effective long-term vascular access with the Duraspan Catheter, with favorable outcomes in terms of catheter longevity and functionality.
What complications have been reported?
Reported complications include catheter-associated bloodstream infections and other catheter-related issues that may lead to treatment interruptions.
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.