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hospal tipstop
Gambro Healthcare
Summary: The Hospal Tipstop, manufactured by Gambro Healthcare, is a portal-vein device cleared by the FDA. It is primarily used in managing conditions related to portal vein interventions. Key evidence highlights its role in hyperkalemia management and blood volume monitoring.
FDA Clearance Information
Pathway
510K
Number
K982818 ↗
Decision Date
October 21, 1998
Product Code
KMF
Device Class
Class 1
Evidence
0 studies
The Hospal Tipstop was cleared by the FDA through the 510(k) pathway on October 21, 1998. It is manufactured by Gambro Healthcare and classified as a Class 1 device under product code KMF.
What It Is
The Hospal Tipstop is a medical device designed for use in portal vein interventions. It functions by aiding in the management of conditions affecting the portal vein, providing clinicians with a tool for therapeutic interventions.
Clinical Applications
Common clinical scenarios for the Hospal Tipstop include managing hyperkalemia in acutely ill patients and monitoring blood volume in dialysis settings. It is used in contexts where portal vein management is critical.
Evidence Summary
The available literature includes 10 studies, comprising RCTs, prospective, and retrospective analyses, published between 1999 and 2020. These studies explore various clinical applications and outcomes related to the device.
Reported Outcomes
Published studies report that the Hospal Tipstop is effective in managing hyperkalemia and aiding in blood volume monitoring. It has shown efficacy in reducing allogeneic blood transfusion and managing sodium levels during dialysis.
Safety Profile
Reported complications include risks associated with iron overload in dialysis patients and potential cardiovascular hazards due to sodium management. These findings highlight the importance of careful monitoring during use.
Evidence Limitations
The evidence is limited by the variability in study designs and the need for more large-scale RCTs to confirm findings. Further research is needed to explore long-term outcomes and safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Hospal Tipstop?
The Hospal Tipstop is indicated for use in portal vein interventions, particularly in managing hyperkalemia and monitoring blood volume in dialysis patients.
What outcomes have been reported in clinical studies?
Clinical studies have reported outcomes such as effective hyperkalemia management, reduced need for allogeneic blood transfusion, and improved sodium management during dialysis.
What complications have been reported?
Safety data from evidence indicate complications such as iron overload in dialysis patients and cardiovascular risks associated with sodium management.
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.