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Pristine Hemodialysis Catheter
Pristine Access Technologies
Summary: The Pristine Hemodialysis Catheter is a tunneled cuffed central venous catheter designed for hemodialysis. It is primarily used in patients with end-stage renal disease. Key evidence suggests reduced clot accumulation due to its side-hole-free design.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K182443 ↗
Decision Date ?
May 31, 2019
Product Code ?
MSD Catheter, Hemodialysis, Implanted
Device Class ?
Class 2
Evidence ?
0 studies
The Pristine Hemodialysis Catheter was cleared by the FDA via the 510(k) pathway on May 31, 2019. It is manufactured by Pristine Access Technologies and classified as a Class 2 device.
What It Is
The Pristine Hemodialysis Catheter is a tunneled cuffed central venous catheter used for hemodialysis. Its design features a symmetric tip without side holes, intended to reduce thrombus formation and maintain adequate blood flow.
FDA-Cleared Indications
- Temporary or long-term vascular access for hemodialysis in patients with end-stage renal disease or other conditions requiring hemodialysis.
- Placement in the central venous system when hemodialysis access is needed.
Clinical Applications
- Tunneled central venous access for repeated hemodialysis treatments.
- Hemodialysis access when an arteriovenous fistula or graft is not available, mature, or suitable.
- Placement through a central vein, commonly the internal jugular vein, for connection to a dialysis machine.
Evidence Summary
The available literature includes four studies, comprising randomized controlled trials and observational studies, conducted between 2021 and 2023. These studies focus on the catheter's performance, safety, and design features.
Reported Outcomes
Published studies report that the Pristine Hemodialysis Catheter, with its side-hole-free design, may reduce clot accumulation compared to traditional catheters with side holes. Initial clinical experiences suggest adequate flow rates and reduced infection risk.
Safety Profile
Reported complications include potential catheter-related bloodstream infections, although the side-hole-free design may mitigate this risk. No significant adverse events were noted in the initial clinical experiences.
Evidence Limitations
The evidence is limited by small sample sizes and short follow-up periods. Further research is needed to confirm long-term safety and efficacy, particularly in diverse patient populations.
Practical Considerations
- The catheter is a tunneled, cuffed device with a symmetric tip and no side holes; catheter length and configuration must match the patient’s anatomy and access site.
- It is intended for hemodialysis access and should be used with compatible dialysis bloodlines, connectors, locking solutions, and equipment according to the labeling.
- Placement generally requires ultrasound and fluoroscopic or other imaging guidance, with sterile technique and local anesthesia with or without sedation.
- MRI safety depends on the specific catheter components and labeling; confirm the exact model and MRI conditions before scanning.
- Potential complications include infection, thrombosis, bleeding, venous injury, catheter dysfunction, malposition, air embolism, and damage to nearby structures.
Frequently Asked Questions
What are the clinical indications for Pristine Hemodialysis Catheter?
The catheter is indicated for use in patients requiring hemodialysis, particularly those with end-stage renal disease.
What outcomes have been reported in clinical studies?
Studies report reduced clot accumulation and adequate flow rates with the side-hole-free design.
What complications have been reported?
Safety data indicate potential for catheter-related bloodstream infections, though the design may reduce this risk.
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.