đź“Š Evidence-Based Reference
2008 hemodialysis sorbent system
Renal Solutions
Summary: The 2008 hemodialysis sorbent system by Renal Solutions is a device used for hemodialysis, primarily in home settings. Key evidence highlights its innovative use of sorbent cartridges for dialysate recycling.
FDA Clearance Information
Pathway
510K
Number
K123835 ↗
Decision Date
February 15, 2013
Product Code
FKT
Device Class
Class 2
Evidence
0 studies
The 2008 hemodialysis sorbent system was cleared by the FDA via the 510(k) pathway on February 15, 2013. It is manufactured by Renal Solutions and classified as a Class 2 device.
What It Is
The 2008 hemodialysis sorbent system is a hemodialysis device that utilizes sorbent technology to purify and recycle dialysate. It is intended for use in patients requiring dialysis, offering a potential solution for home hemodialysis.
Clinical Applications
This device is commonly used in home hemodialysis settings, providing an option for patients who require regular dialysis but prefer or need to perform it outside of a clinical environment.
Evidence Summary
The available literature includes five studies, with a mix of study types such as RCTs and case series, spanning from 2008 to 2024. These studies explore the clinical application and technological advancements of sorbent hemodialysis.
Reported Outcomes
Published studies report that the 2008 hemodialysis sorbent system effectively recycles dialysate using sorbent cartridges, which may enhance the feasibility of home hemodialysis. Clinical experiences suggest improvements in patient convenience and potential cost savings.
Safety Profile
Reported complications include potential immunologic and non-immunologic reactions due to continuous blood-artificial membrane interactions. However, specific adverse events related to the sorbent system itself are not detailed in the provided evidence.
Evidence Limitations
The evidence is limited by a lack of large-scale, long-term studies specifically focused on the 2008 hemodialysis sorbent system. Further research is needed to fully understand its safety profile and long-term efficacy in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for 2008 hemodialysis sorbent system?
The device is indicated for patients requiring hemodialysis, particularly in home settings.
What outcomes have been reported in clinical studies?
Studies report effective dialysate recycling and potential improvements in home dialysis feasibility.
What complications have been reported?
Safety data indicate potential immunologic and non-immunologic reactions, though specific adverse events are not detailed.
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.