đź“Š Evidence-Based Reference
gore viatorr tips endoprosthesis and gore viatorr tips endoprosthesis with controlled expansion
W.L. Gore & Associates
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
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.
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.
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.
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.