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Hemo-Stream Hemodialysis Catheter Set
Summary: The hemo-stream hemodialysis catheter set by Rex Medical is used for vascular access in hemodialysis. Key evidence highlights its use in patients with limited peripheral vessel access and complications like fibrin sheath formation.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K023847 ↗
Decision Date ?
April 30, 2003
Product Code ?
MSD Catheter, Hemodialysis, Implanted
Device Class ?
Class 2
Evidence ?
0 studies
The hemo-stream hemodialysis catheter set was cleared by the FDA via the 510(k) pathway on April 30, 2003. It is manufactured by Rex Medical and classified as a Class 2 device.
What It Is
The hemo-stream hemodialysis catheter set is a medical device designed to provide vascular access for hemodialysis. It is intended for patients requiring long-term dialysis, particularly those with limited peripheral vascular access.
FDA-Cleared Indications
- Vascular access for hemodialysis.
- Use in patients requiring hemodialysis when suitable peripheral vascular access is limited or unavailable.
Clinical Applications
- Establishing central venous access for hemodialysis.
- Providing repeated vascular access for patients with end-stage kidney disease receiving hemodialysis.
- Use when peripheral vessels are inadequate for creation or maintenance of other dialysis access options.
Evidence Summary
The available literature includes 9 studies, encompassing various study types such as RCTs and case series. The studies span from recent years, providing insights into the device's clinical performance.
Reported Outcomes
Published studies report that the hemo-stream catheter is effective in providing reliable vascular access for hemodialysis. It is noted for its utility in patients with limited vascular access options, although complications like fibrin sheath formation can affect its performance.
Safety Profile
Reported complications include fibrin sheath formation, which can lead to catheter malfunction. Other potential adverse events are related to long-term indwelling catheter use, such as infection and thrombosis.
Evidence Limitations
The evidence base is limited by the small number of studies focusing specifically on this device. Further research is needed to explore long-term outcomes and compare its efficacy with alternative dialysis access methods.
Practical Considerations
- The catheter is placed in a central vein, commonly the internal jugular or femoral vein; subclavian access may be avoided when possible because of the risk of central venous stenosis in dialysis patients.
- Placement is generally performed using ultrasound and fluoroscopic or other imaging guidance, with local anesthesia and sedation when appropriate.
- Catheter size and length must be selected for the patient’s anatomy and intended access site. The catheter should be used only with compatible dialysis equipment and according to its instructions for use.
- Risks include infection, bleeding, thrombosis, malposition, vessel injury, air embolism, catheter dysfunction and fibrin sheath formation.
- MRI safety depends on the exact catheter components and labeling. The device should be identified and its current MRI conditions reviewed before an MRI examination.
Frequently Asked Questions
What are the clinical indications for hemo-stream hemodialysis catheter set?
The device is indicated for providing vascular access in patients requiring long-term hemodialysis, especially those with limited peripheral vessel access.
What outcomes have been reported in clinical studies?
Studies report effective vascular access for hemodialysis, with noted complications such as fibrin sheath formation affecting performance.
What complications have been reported?
Safety data indicate complications such as fibrin sheath formation, infection, and thrombosis associated with long-term catheter use.
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.