đź“Š Evidence-Based Reference
hemo-stream hemodialysis catheter set
Rex Medical
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 510K
Number K023847 ↗
Decision Date April 30, 2003
Product Code MSD
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.
Clinical Applications
This device is commonly used in patients with end-stage kidney disease who require regular hemodialysis. It is particularly useful in older patients with exhausted peripheral vessel resources.
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.
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.