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Nexsite HD Hemodialysis Catheter for Long Term Use 32cm Nexsite HD Hemodialysis Catheter for Long Term Use 36cm
Summary: The NexSite HD Hemodialysis Catheter is designed for long-term hemodialysis access. It incorporates Exit Site Management technology to reduce infection risk. Key evidence highlights its potential in decreasing catheter-related bloodstream infections.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K133796 ↗
Decision Date ?
January 31, 2014
Product Code ?
MSD Catheter, Hemodialysis, Implanted
Device Class ?
Class 2
Evidence ?
0 studies
The NexSite HD Hemodialysis Catheter was cleared by the FDA via the 510(k) pathway on January 31, 2014. 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 tunneled central venous catheter designed for long-term hemodialysis. It features Exit Site Management technology to minimize bacterial colonization at the catheter exit site, thereby reducing infection risk.
FDA-Cleared Indications
- Long-term vascular access for hemodialysis.
- Use in patients who require hemodialysis through a tunneled central venous catheter.
Clinical Applications
- Providing central venous access for repeated hemodialysis treatments.
- Use as tunneled dialysis access when an arteriovenous fistula or graft is unavailable, unsuitable, or not yet ready for use.
- Use in patients requiring longer-term hemodialysis access rather than a short-term, nontunneled catheter.
Evidence Summary
The available literature includes two studies: a prospective observational study published in 2020 and an ongoing clinical trial. These studies focus on the catheter's impact on infection rates and its clinical performance.
Reported Outcomes
Published studies report that the NexSite HD catheter may reduce catheter-related bloodstream infections due to its innovative exit site management technology. The prospective observational study highlights improved clinical outcomes in infection control.
Safety Profile
Reported complications include potential risks associated with central venous catheters, such as infection and thrombosis. However, specific safety data from the provided studies are limited.
Evidence Limitations
The evidence is limited by the small number of studies and lack of comprehensive safety data. Further research is needed to confirm long-term efficacy and safety across diverse patient populations.
Practical Considerations
- Available configurations listed in this record are 32 cm and 36 cm; the appropriate length depends on the selected venous access route, patient anatomy, and catheter-tip position.
- Placement is generally performed through a central vein, commonly the internal jugular vein, with subcutaneous tunneling to an exit site on the chest.
- The catheter is intended for hemodialysis and should be used only with compatible dialysis equipment, connectors, flush solutions, and anticoagulation protocols specified in the device labeling.
- MRI safety and conditions should be confirmed in the current manufacturer instructions for use; this record does not establish an MR Safe or MR Conditional designation.
- Potential complications include infection, thrombosis, bleeding, air embolism, catheter malfunction, vessel injury, and malposition. Patient-specific contraindications and precautions should be reviewed before placement.
Frequently Asked Questions
What are the clinical indications for NexSite HD Hemodialysis Catheter?
The catheter is indicated for long-term hemodialysis access, particularly in patients at risk for catheter-related bloodstream infections.
What outcomes have been reported in clinical studies?
Studies report a reduction in catheter-related bloodstream infections due to the catheter's exit site management technology.
What complications have been reported?
Reported complications include infection and thrombosis, common risks associated with central venous catheters.
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.