📊 Evidence-Based Reference
Integral Hemodialysis Catheter
Arrow Int'L.
Summary: The integral hemodialysis catheter by Arrow Int'L. is used for vascular access in hemodialysis. Key evidence highlights its role in managing dialysis access with noted complications such as central vein stenosis.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K040260 ↗
Decision Date ?
March 5, 2004
Product Code ?
MSD Catheter, Hemodialysis, Implanted
Device Class ?
Class 2
Evidence ?
0 studies
The integral hemodialysis catheter was cleared via the FDA 510(k) pathway on March 5, 2004. It is manufactured by Arrow Int'L. and classified as a Class 2 device.
What It Is
The integral hemodialysis catheter is a medical device designed to provide vascular access for hemodialysis. It is intended for patients requiring dialysis when other forms of vascular access are not feasible.
FDA-Cleared Indications
- Provides vascular access for hemodialysis.
- Used when other forms of hemodialysis vascular access are not feasible.
Clinical Applications
- Accessing the central venous circulation for hemodialysis.
- Providing dialysis access when an arteriovenous fistula cannot be created or used.
- Providing dialysis access when an arteriovenous graft is not available or suitable.
- Supporting hemodialysis while a fistula or graft matures, when applicable to the labeled catheter configuration.
Evidence Summary
The literature includes 9 studies, comprising retrospective analyses and case reports, published between 2018 and 2025. These studies explore various aspects of catheter use, including positioning and complications.
Reported Outcomes
Published studies report that the integral hemodialysis catheter effectively provides vascular access for dialysis. However, complications such as catheter-related bloodstream infections and mechanical issues like vein obstruction have been noted.
Safety Profile
Reported complications include central vein stenosis, thrombosis, and catheter-related bloodstream infections. Proper insertion techniques and imaging guidance are recommended to mitigate these risks.
Evidence Limitations
The evidence is limited by the retrospective nature of many studies and the lack of large-scale randomized controlled trials. Further research is needed to optimize insertion techniques and reduce complication rates.
Practical Considerations
- Catheter length, diameter, lumen configuration, and tip design must match the patient's anatomy, access site, prescribed dialysis flow, and the specific product labeling.
- Common access sites include the internal jugular, femoral, and subclavian veins; subclavian access may increase the risk of central vein stenosis and can affect future fistula or graft options.
- Placement is generally performed with ultrasound and fluoroscopic or other imaging guidance, using sterile technique and local anesthesia with or without moderate sedation.
- MRI safety depends on the exact catheter model and any associated components. Confirm the device-specific MRI labeling before scanning.
- Potential complications include infection, thrombosis, malposition, bleeding, vessel injury, air embolism, catheter dysfunction, and central venous stenosis.
Frequently Asked Questions
What are the clinical indications for integral hemodialysis catheter?
The catheter is indicated for patients requiring vascular access for hemodialysis, particularly when other access methods are not feasible.
What outcomes have been reported in clinical studies?
Studies report effective dialysis access but highlight risks of infections and mechanical complications.
What complications have been reported?
Safety data indicate risks of central vein stenosis, thrombosis, 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.