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Gore TIPS Set Gore TIPS Sheath Gore TIPS Needle
Creganna Medical Aslo Business As Cregganna Tactx Medical
Summary: The Gore TIPS Set is a medical device used for transjugular intrahepatic portosystemic shunt (TIPS) procedures, primarily to manage complications of portal hypertension. Key evidence highlights its role in survival prediction models post-TIPS implantation.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K152913 ↗
Decision Date ?
July 21, 2016
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The Gore TIPS Set was cleared by the FDA through the 510(k) pathway on July 21, 2016. It is manufactured by Creganna Medical and classified as a Class 2 device under product code DYB.
What It Is
The Gore TIPS Set includes a sheath and needle designed for the creation of a transjugular intrahepatic portosystemic shunt (TIPS), which is used to treat complications arising from portal hypertension by creating a channel within the liver to reduce portal vein pressure.
FDA-Cleared Indications
- Creation of a transjugular intrahepatic portosystemic shunt (TIPS).
- Accessing the portal venous system from the jugular venous system during TIPS procedures.
Clinical Applications
- Image-guided creation of a TIPS for portal hypertension.
- Treatment of complications of portal hypertension when a TIPS procedure is clinically indicated.
- Transjugular access to the portal vein through the hepatic veins during shunt creation.
Evidence Summary
The available literature includes a mix of study types such as RCTs and registries, with a focus on survival prediction and device efficacy. The studies span from 2022 to the present, highlighting ongoing research in this area.
Reported Outcomes
Published studies report that the Gore TIPS Set is effective in managing portal hypertension complications, with improved survival rates when used in conjunction with novel prognostic models. The device's role in survival prediction post-TIPS is a significant finding.
Safety Profile
Reported complications include typical risks associated with TIPS procedures, such as shunt dysfunction and hepatic encephalopathy. However, specific safety data from the provided studies are limited.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of comprehensive safety data. Further research is needed to explore long-term outcomes and potential complications in diverse patient populations.
Practical Considerations
- The set is used with fluoroscopic and other appropriate imaging guidance by clinicians trained in transjugular hepatic access and TIPS procedures.
- The sheath and needle must be selected and used according to the device labeling, procedural anatomy, and compatibility requirements of the other equipment.
- Access is typically obtained through the internal jugular vein, with the system advanced through the hepatic vein toward a branch of the portal vein.
- MRI safety and conditional-use information should be confirmed in the current manufacturer labeling; the device should not be assumed to be MRI safe without verification.
- Potential procedural risks include bleeding, capsular perforation, vascular injury, infection, contrast reaction, and complications associated with TIPS itself.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for Gore TIPS Set?
The Gore TIPS Set is indicated for use in patients with portal hypertension to manage complications such as variceal bleeding and refractory ascites.
What outcomes have been reported in clinical studies?
Studies report improved survival rates and effective management of portal hypertension complications when using the Gore TIPS Set.
What complications have been reported?
Reported complications include shunt dysfunction and hepatic encephalopathy, common in TIPS procedures.
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.