đź“Š Evidence-Based Reference
Ultrastream Chronic Hemodialysis Catheter
Product: UltraStream Chronic Dialysis Catheter Exchange Kit — all models and sizes
Summary: The Ultrastream Chronic Hemodialysis Catheter by Rex Medical is used for hemodialysis in patients with kidney failure. Key evidence highlights issues like catheter dysfunction and bloodstream infections.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K102043 ↗
Decision Date ?
November 18, 2010
Product Code ?
MSD Catheter, Hemodialysis, Implanted
Device Class ?
Class 2
Evidence ?
0 studies
The Ultrastream Chronic Hemodialysis Catheter was cleared by the FDA via the 510(k) pathway on November 18, 2010. It is manufactured by Rex Medical and classified as a Class 2 device.
What It Is
The Ultrastream Chronic Hemodialysis Catheter is a central venous catheter designed for long-term hemodialysis in patients with chronic kidney disease. It facilitates efficient blood flow for dialysis treatment.
FDA-Cleared Indications
- For use as a vascular access device for hemodialysis.
- For chronic hemodialysis access in patients who require dialysis treatment.
Clinical Applications
- Providing access to the bloodstream during chronic hemodialysis.
- Supporting repeated hemodialysis treatments in patients with kidney failure.
- Providing an alternative dialysis access route when an arteriovenous fistula or graft is unavailable, unsuitable, or not ready for use.
Evidence Summary
The literature includes 10 studies ranging from 2023 to 2025, encompassing various study types such as RCTs and observational studies. These studies focus on catheter-related complications and interventions.
Reported Outcomes
Published studies report that catheter dysfunction and catheter-related bloodstream infections (CRBSIs) are significant concerns. Strategies to prevent these issues include the use of antimicrobial lock solutions and careful catheter management.
Safety Profile
Reported complications include catheter dysfunction due to thrombosis and fibrin sheath formation, as well as CRBSIs. These complications can lead to significant morbidity and necessitate catheter removal.
Evidence Limitations
The evidence is limited by a lack of large-scale randomized controlled trials specifically evaluating the Ultrastream catheter. Further research is needed to explore long-term outcomes and optimal management strategies.
Practical Considerations
- The catheter is placed in a central vein, commonly through the internal jugular vein, with the tip positioned in a large central vein near the heart; exact placement depends on patient anatomy and clinical judgment.
- Catheter size, length, lumen configuration, and blood-flow performance must be selected for the patient and dialysis system according to the product labeling and institutional protocol.
- Placement and removal require sterile technique and are commonly performed with ultrasound and fluoroscopic or other imaging guidance, using local anesthesia with or without procedural sedation.
- Important risks include catheter dysfunction, thrombosis, bleeding, vessel injury, air embolism, and bloodstream or exit-site infection.
- MRI safety and conditions should be confirmed in the current manufacturer labeling; the catheter should not be assumed to be MRI safe without device-specific verification.
Frequently Asked Questions
What are the clinical indications for ultrastream chronic hemodialysis catheter?
The catheter is indicated for long-term hemodialysis in patients with chronic kidney disease who require vascular access.
What outcomes have been reported in clinical studies?
Studies have reported issues such as catheter dysfunction and bloodstream infections, with interventions focusing on prevention and management.
What complications have been reported?
Safety data indicate complications like thrombosis, fibrin sheath formation, and catheter-related bloodstream infections.
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.