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viatorr endoprosthesis
W.L. Gore & Associates
Summary: The Viatorr Endoprosthesis is a device used primarily for transjugular intrahepatic portosystemic shunt (TIPS) procedures. Key evidence highlights its role in maintaining shunt patency and addressing venous steno-occlusive disease.
FDA Clearance Information
Pathway 510K
Number K024178 ↗
Decision Date March 7, 2003
Product Code JCT
Device Class Class 2
Evidence 0 studies
The Viatorr Endoprosthesis was cleared by the FDA via the 510(k) pathway on March 7, 2003. It is manufactured by W.L. Gore & Associates and classified as a Class 2 device.
What It Is
The Viatorr Endoprosthesis is a stent-graft designed for use in TIPS procedures. It is intended to maintain patency of the shunt and improve blood flow in patients with portal hypertension.
Clinical Applications
Commonly used in the management of portal hypertension, the Viatorr Endoprosthesis is applied in TIPS procedures to reduce portal pressure and manage complications like variceal bleeding.
Evidence Summary
The literature includes 11 studies ranging from 2003 to 2023, encompassing RCTs, prospective, retrospective, and case series designs. These studies evaluate the device's efficacy and safety in various clinical scenarios.
Reported Outcomes
Published studies report that the Viatorr Endoprosthesis effectively maintains shunt patency in TIPS procedures and may improve outcomes in venous steno-occlusive disease. It has been associated with increased secondary patency rates in TIPS revisions.
Safety Profile
Reported complications include the risk of hepatic encephalopathy post-TIPS creation and potential issues with stent deployment. Some studies highlight the need for careful monitoring and management of these risks.
Evidence Limitations
Evidence gaps include limited long-term follow-up data and variability in study designs. Further research is needed to explore the device's efficacy in diverse patient populations and refine deployment techniques.
Frequently Asked Questions
What are the clinical indications for Viatorr Endoprosthesis?
The Viatorr Endoprosthesis is indicated for use in TIPS procedures to manage portal hypertension and related complications.
What outcomes have been reported in clinical studies?
Studies report effective maintenance of shunt patency and improved outcomes in managing venous steno-occlusive disease.
What complications have been reported?
Safety data indicate risks of hepatic encephalopathy and deployment issues, necessitating careful clinical 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.