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Nexsite HD Hemodialysis Catheter for Long Term Use 28cm Nexsite HD Hemodialysis Catheter for Long Term Use 24cm
Summary: The NexSite HD Hemodialysis Catheter is a tunneled central venous catheter designed for long-term hemodialysis. It incorporates Exit Site Management technology to reduce infection risk. Key evidence suggests improved CRBSI rates.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K121933 ↗
Decision Date ?
March 14, 2013
Product Code ?
MSD Catheter, Hemodialysis, Implanted
Device Class ?
Class 2
Evidence ?
0 studies
The NexSite HD Hemodialysis Catheter was cleared via the FDA 510(k) pathway on March 14, 2013. Manufactured by Marvao Medical Devices, it is classified as a Class 2 device under product code MSD.
What It Is
The NexSite HD Hemodialysis Catheter is a medical device used for long-term vascular access in hemodialysis patients. It features a unique Exit Site Management technology aimed at reducing bacterial colonization and infection risk at the catheter exit site.
FDA-Cleared Indications
- Long-term vascular access for hemodialysis.
- Use in patients who require hemodialysis when an arteriovenous fistula or graft is not available, appropriate, or usable.
Clinical Applications
- Providing central venous access for repeated hemodialysis treatments.
- Use as tunneled dialysis access in patients needing longer-term catheter-based access.
- Placement through a central vein, commonly the internal jugular vein, when clinically appropriate.
Evidence Summary
The available literature includes two studies: one published in 2020 and another with an unknown date. These studies include a prospective observational study and an analysis of CRBSI rates, focusing on the catheter's clinical performance and safety.
Reported Outcomes
Published studies report that the NexSite HD catheter is associated with improved clinical outcomes, particularly in reducing catheter-related bloodstream infections (CRBSIs). The use of Exit Site Management technology has been shown to decrease bacterial colonization at the catheter exit site, contributing to better patient outcomes.
Safety Profile
Reported complications include catheter-related bloodstream infections, although the use of the NexSite HD catheter has been associated with a reduction in these events. No other specific adverse events are detailed in the provided evidence.
Evidence Limitations
The evidence is limited to two studies, with one lacking a publication date. Further research is needed to confirm long-term safety and efficacy, as well as to explore additional clinical scenarios and patient populations.
Practical Considerations
- The listed catheter lengths are 24 cm and 28 cm; the appropriate length depends on the access vein, tunneling route, and catheter tip position.
- Placement is typically performed using sterile technique and imaging guidance, such as ultrasound and fluoroscopy, by a trained clinician.
- The catheter is intended for hemodialysis access and should not be assumed to be compatible with infusion, power injection, or other uses unless the device labeling specifically allows them.
- MRI safety and conditional scanning requirements should be confirmed in the current manufacturer labeling before an MRI examination.
- Potential complications include infection, catheter thrombosis or malfunction, bleeding, vessel injury, air embolism, malposition, and central venous narrowing.
Frequently Asked Questions
What are the clinical indications for NexSite HD Hemodialysis Catheter?
The NexSite HD Hemodialysis Catheter is indicated for long-term vascular access in patients undergoing hemodialysis.
What outcomes have been reported in clinical studies?
Studies have reported improved outcomes in reducing catheter-related bloodstream infections due to the catheter's Exit Site Management technology.
What complications have been reported?
Reported complications include catheter-related bloodstream infections, though the device is associated with a reduction in these events.
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.