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transjugular liver access sets
Cook
Summary: Transjugular liver access sets by Cook are used for creating intrahepatic portosystemic shunts. Key evidence includes safety and effectiveness in animal models.
FDA Clearance Information
Pathway
510K
Number
K171820 ↗
Decision Date
March 9, 2018
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Cook transjugular liver access sets received FDA clearance through the 510(k) pathway on March 9, 2018. It is classified as a Class 2 device.
What It Is
Transjugular liver access sets are medical devices used to create intrahepatic portosystemic shunts. They facilitate access to the liver via the jugular vein, primarily for interventional radiology procedures.
Clinical Applications
These devices are commonly used in procedures requiring the creation of transjugular intrahepatic portosystemic shunts (TIPS), particularly in patients with portal hypertension or variceal bleeding.
Evidence Summary
The literature includes six studies, with types ranging from RCTs to case series, conducted between 2021 and 2025. The studies focus on device safety, effectiveness, and feasibility.
Reported Outcomes
Published studies report the successful creation of TIPS using the device, with effective delivery and function in animal models. The steerable cannula design has been highlighted for its ergonomic benefits.
Safety Profile
Reported complications include potential device-related adverse events observed in animal models. However, specific human safety data is limited in the provided studies.
Evidence Limitations
The evidence is primarily based on animal models, with limited human clinical data. Further research is needed to establish long-term outcomes and safety in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for transjugular liver access sets?
The device is indicated for creating transjugular intrahepatic portosystemic shunts, particularly in cases of portal hypertension.
What outcomes have been reported in clinical studies?
Studies have reported successful shunt creation and effective device function in animal models, with ergonomic advantages noted.
What complications have been reported?
Safety data from studies indicate potential adverse events in animal models, but detailed human safety data is limited.
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.