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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
510K
Number
K182443 ↗
Decision Date
May 31, 2019
Product Code
MSD
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.
Clinical Applications
This catheter is commonly used in patients with end-stage renal disease who require hemodialysis. It is typically placed in the internal jugular vein and is intended for long-term vascular access.
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.
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.