đź“Š Evidence-Based Reference
Centros Long Term Hemodialysis Catheter Centrosflo Long Term Hemodialysis Catheter
Summary: The Centros long term hemodialysis catheter is a device used for vascular access in hemodialysis patients. Key evidence highlights its role in reducing catheter-related complications.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K141363 ↗
Decision Date ?
June 18, 2014
Product Code ?
MSD Catheter, Hemodialysis, Implanted
Device Class ?
Class 2
Evidence ?
0 studies
The Centros long term hemodialysis catheter was cleared by the FDA through the 510(k) pathway on June 18, 2014. It is manufactured by Merit Medical Systems and classified as a Class 2 device.
What It Is
The Centros long term hemodialysis catheter is designed for providing vascular access in patients undergoing hemodialysis. It is intended for long-term use and is inserted into a central vein to facilitate efficient blood flow during dialysis sessions.
FDA-Cleared Indications
- Provide long-term vascular access for hemodialysis.
- Use in patients who require hemodialysis and need a central venous catheter.
- Placement in a central vein to permit withdrawal and return of blood during dialysis.
Clinical Applications
- Tunneled central venous access for chronic hemodialysis.
- Hemodialysis access when an arteriovenous fistula or graft is not available, not mature, or cannot be created.
- Hemodialysis access when temporary or longer-term central venous access is clinically required.
Evidence Summary
The available literature includes 10 studies, encompassing various study types such as RCTs and retrospective analyses. These studies span from 2024 to 2026, providing insights into the catheter's clinical performance and safety profile.
Reported Outcomes
Published studies report that the Centros catheter is effective in maintaining vascular access for hemodialysis with a focus on reducing catheter-related bloodstream infections. The evidence suggests improved patient outcomes in terms of access longevity and reduced intervention rates.
Safety Profile
Reported complications include catheter-related bloodstream infections, which remain a significant concern. However, the studies highlight efforts to mitigate these risks through improved catheter design and prophylactic measures.
Evidence Limitations
The evidence is limited by small sample sizes and short follow-up periods in some studies. Further research is needed to establish long-term safety and efficacy, as well as to optimize infection prevention strategies.
Practical Considerations
- Placement is generally performed through a central vein, commonly the internal jugular vein, with the catheter tunneled under the skin and the tip positioned in a large central vein under imaging guidance.
- The catheter is intended for hemodialysis access and should be used and maintained according to the manufacturer’s instructions and dialysis-access protocols.
- Available configurations and catheter lengths or sizes depend on the specific Centros or CentrosFlo model and should be selected for the patient’s anatomy and treatment requirements.
- Check the specific product labeling for MRI conditions, as MR safety status and permitted scanning conditions can vary by model.
- Potential complications include infection, thrombosis, bleeding, catheter malposition, central venous stenosis, dysfunction, air embolism, and vessel or organ injury.
Frequently Asked Questions
What are the clinical indications for Centros long term hemodialysis catheter?
The catheter is indicated for providing long-term vascular access in patients undergoing hemodialysis, particularly when other access methods are not suitable.
What outcomes have been reported in clinical studies?
Studies report effective maintenance of vascular access with reduced rates of catheter-related complications, particularly infections.
What complications have been reported?
Safety data indicate catheter-related bloodstream infections as a primary complication, with ongoing efforts to reduce these risks.
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.