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Gore Viatorr TIPS Endoprosthesis and Gore Viatorr TIPS Endoprosthesis with Controlled Expansion
Product: GORE VIATORR TIPS Endoprosthesis — all models and sizes
Summary: The Gore Viatorr TIPS Endoprosthesis is a device used for creating transjugular intrahepatic portosystemic shunts (TIPS) in patients with portal hypertension. Key evidence highlights its efficacy in maintaining hemodialysis access and controlled expansion capabilities.
FDA Clearance Information
Pathway ?
PMA
Number ?
P040027 ↗
Decision Date ?
July 15, 2020
Product Code ?
MIR Shunt, Portosystemic, Endoprosthesis
Device Class ?
Class 3
Evidence ?
0 studies
The Gore Viatorr TIPS Endoprosthesis was cleared by the FDA via the PMA pathway on July 15, 2020. It is manufactured by W.L. Gore & Associates and is classified as a Class III medical device.
What It Is
The Gore Viatorr TIPS Endoprosthesis is a stent graft designed for the creation of transjugular intrahepatic portosystemic shunts (TIPS) to manage portal hypertension. It features a controlled expansion mechanism to optimize blood flow and reduce portal pressure.
FDA-Cleared Indications
- Change to the knitting process equipment for a delivery-system component.
Clinical Applications
This device is commonly used in patients with liver cirrhosis who require a TIPS procedure to alleviate portal hypertension. It is also utilized in maintaining hemodialysis access in cases of venous steno-occlusive disease.
Reported off-label uses
- Creation of a TIPS to treat complications of portal hypertension, such as variceal bleeding or refractory ascites, when performed according to applicable device labeling and clinical judgment.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Evidence Summary
The available literature includes 14 studies, comprising various study types such as RCTs and case series, conducted between 2019 and 2023. These studies explore the device's efficacy and safety in clinical settings.
Reported Outcomes
Published studies report that the Gore Viatorr TIPS Endoprosthesis effectively maintains hemodialysis access and provides controlled expansion in TIPS procedures. It has shown favorable outcomes in reducing portal hypertension and improving blood flow dynamics.
Safety Profile
Reported complications include limited clinical acceptance of 4D flow CMR due to validation challenges and potential issues with physical properties in experimental setups. Overall, the device is considered safe with manageable risks.
Evidence Limitations
Evidence gaps include the need for further validation of 4D flow CMR in clinical settings and more comprehensive studies on long-term outcomes. Current studies are limited by small sample sizes and lack of diverse patient populations.
Practical Considerations
- The device is intended for placement through a transjugular approach using fluoroscopic and other imaging guidance; it connects a hepatic vein with a branch of the portal vein.
- Available diameter and length options, as well as controlled-expansion features, must be matched to the patient's anatomy and the treatment plan.
- The device is delivered through a compatible sheath or catheter system. Operators should confirm the current instructions for use, delivery-system compatibility, and deployment technique.
- MRI conditions should be confirmed in the current manufacturer labeling before scanning. Patients should tell MRI staff that they have a TIPS endoprosthesis.
- Potential clinical issues include bleeding, infection, stent-graft migration or occlusion, hepatic encephalopathy, and excessive reduction of portal blood flow. Patient selection and follow-up imaging are important.
Frequently Asked Questions
What are the clinical indications for Gore Viatorr TIPS Endoprosthesis?
The device is indicated for creating TIPS in patients with portal hypertension and maintaining hemodialysis access in venous steno-occlusive disease.
What outcomes have been reported in clinical studies?
Studies report effective maintenance of hemodialysis access and controlled expansion in TIPS procedures, improving portal hypertension management.
What complications have been reported?
Reported complications include challenges in clinical acceptance of 4D flow CMR and potential issues with physical properties in experimental setups.
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.