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Nextstep Antegrade Chronic Hemodialysis Catheter
Teleflexmedical
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Summary: The NextStep Antegrade Chronic Hemodialysis Catheter is a medical device used for vascular access in hemodialysis patients. It is primarily used by nephrologists and interventional radiologists to facilitate dialysis treatment.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K111900 ↗
Decision Date ?
August 17, 2011
Product Code ?
MSD Catheter, Hemodialysis, Implanted
Device Class ?
Class 2
Evidence ?
0 studies
The NextStep Antegrade Catheter was cleared via the FDA 510(k) pathway on August 17, 2011. Manufactured by Teleflexmedical, it is classified as a Class 2 device under product code MSD.
What It Is
The NextStep Antegrade Chronic Hemodialysis Catheter is designed for long-term vascular access in patients requiring hemodialysis. It is an antegrade catheter, meaning it is inserted in the same direction as blood flow, which can help reduce complications associated with retrograde flow. The device is typically inserted into a central vein, such as the internal jugular or subclavian vein, to facilitate efficient dialysis treatment.
FDA-Cleared Indications
- Provide vascular access for patients undergoing chronic hemodialysis.
- Provide repeated access to the bloodstream for dialysis treatment when chronic hemodialysis access is required.
Clinical Applications
- Tunneled central venous access for chronic hemodialysis.
- Hemodialysis access in patients who require repeated dialysis treatments.
- Dialysis access placed through a central vein, commonly the internal jugular vein, when clinically appropriate.
- Use in hospital, dialysis-center, or interventional radiology settings for establishing chronic dialysis access.
Practical Considerations
- The catheter must be selected in an appropriate length and size for the patient's anatomy and dialysis system.
- It is commonly placed using ultrasound and fluoroscopic guidance, with local anesthesia and sedation when appropriate.
- The catheter and connectors must be compatible with the prescribed hemodialysis equipment and handled using sterile technique.
- The exit site and catheter function require regular assessment for infection, thrombosis, malfunction, bleeding, or dislodgement.
- MRI safety depends on the exact catheter and component configuration; the product-specific labeling should be reviewed before MRI. General contraindications and precautions include active infection at the insertion site, unsuitable venous anatomy, and inability to safely maintain the catheter.
Frequently Asked Questions
What is the NextStep Antegrade Chronic Hemodialysis Catheter used for?
It is used for providing long-term vascular access in patients requiring chronic hemodialysis.
What specialties typically use this device?
Nephrologists and interventional radiologists typically use this device for managing dialysis patients.
What are the FDA-cleared indications?
The catheter is indicated for providing vascular access for patients undergoing chronic hemodialysis.
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.