📊 Evidence-Based Reference
Amecath Dual Lumen Implanted Hemodialysis Catheter
Product: Amecath Twincath catheter — all models and sizes · Where to buy
Summary: The Amecath dual lumen implanted hemodialysis catheter is designed for vascular access in hemodialysis patients. It is FDA 510k cleared and supported by 10 studies, highlighting its use in dialysis and associated outcomes.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K131814 ↗
Decision Date ?
July 26, 2013
Product Code ?
MSD Catheter, Hemodialysis, Implanted
Device Class ?
Class 2
Evidence ?
0 studies
The Amecath dual lumen implanted hemodialysis catheter was cleared by the FDA via the 510k pathway on July 26, 2013. It is manufactured by Ameco Medical Industries and classified as a Class 2 device.
What It Is
The Amecath dual lumen implanted hemodialysis catheter is a vascular access device used in hemodialysis. It facilitates efficient blood flow for dialysis treatment and is intended for patients requiring long-term dialysis access.
FDA-Cleared Indications
- Vascular access for hemodialysis.
- Use in patients requiring hemodialysis access through an implanted, dual-lumen catheter.
Clinical Applications
- Long-term vascular access for repeated hemodialysis treatments.
- Withdrawal of blood from the patient for passage through a hemodialysis machine.
- Return of dialyzed blood to the patient through the catheter's second lumen.
- Hemodialysis access when an arteriovenous fistula or graft is not available, suitable, or usable.
Evidence Summary
The available literature includes 10 studies, encompassing various study types such as RCTs and case series, conducted between 2015 and 2025. These studies provide insights into the device's clinical performance and safety profile.
Reported Outcomes
Published studies report that the Amecath catheter effectively provides reliable vascular access for hemodialysis, with satisfactory blood flow rates. Clinical outcomes indicate a reduction in dialysis-related complications when used appropriately.
Safety Profile
Reported complications include infection risks associated with long-term catheter use, as well as potential for central venous stenosis. These complications highlight the need for careful monitoring and management in clinical practice.
Evidence Limitations
The evidence is limited by the small sample sizes and the retrospective nature of some studies. Further research is needed to explore long-term outcomes and compare efficacy with alternative dialysis access methods.
Practical Considerations
- The catheter has two lumens: one for blood withdrawal and one for blood return during dialysis.
- Placement typically uses image guidance, with the catheter entering a central vein such as the internal jugular or femoral vein and the tip positioned in a central thoracic vein or the right atrium, according to clinical technique and labeling.
- Available lengths, French sizes, tip configurations, and flow characteristics depend on the specific catheter model; users should verify the product instructions before placement.
- MRI safety and conditional requirements are model-specific. Confirm the exact catheter's FDA labeling or manufacturer instructions before MRI.
- Important risks include infection, thrombosis, catheter dysfunction, bleeding, vessel injury, air embolism, and central venous stenosis. Placement and maintenance require sterile technique and trained dialysis or vascular-access personnel.
Frequently Asked Questions
What are the clinical indications for the Amecath dual lumen implanted hemodialysis catheter?
The catheter is indicated for patients requiring long-term vascular access for hemodialysis, particularly when other access methods are not suitable.
What outcomes have been reported in clinical studies?
Studies report effective blood flow rates and reduced dialysis-related complications when the catheter is used appropriately.
What complications have been reported?
Safety data indicate risks of infection and central venous stenosis 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.