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nexsite hd hemodialysis catheter for long term use 28cm nexsite hd hemodialysis catheter for long term use 24cm
Marvao Medical Devices
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 510K
Number K121933 ↗
Decision Date March 14, 2013
Product Code MSD
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.
Clinical Applications
This catheter is commonly used in patients requiring long-term hemodialysis, particularly in cases where traditional vascular access is not feasible. It is designed to provide reliable and safe access to the bloodstream for dialysis treatments.
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.
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.