đź“Š Evidence-Based Reference
Viatorr Endoprosthesis
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 ?
510(k)
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.
FDA-Cleared Indications
- For use in creating and maintaining a transjugular intrahepatic portosystemic shunt (TIPS).
- For treating portal venous hypertension when a TIPS procedure is clinically indicated.
- For maintaining shunt patency by providing a covered passage between the portal and hepatic venous systems.
Clinical Applications
- TIPS creation for portal hypertension.
- Reduction of portal pressure in selected patients with complications of portal hypertension.
- Management of variceal bleeding when TIPS is indicated.
- Treatment of selected portal-hypertension complications requiring a durable intrahepatic portosystemic channel.
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.
Practical Considerations
- The device is deployed through venous access, typically through the internal jugular vein, using fluoroscopic and contrast imaging guidance.
- Device diameter and length must be selected to match the hepatic and portal venous anatomy and the planned shunt tract.
- The covered and uncovered portions must be positioned correctly so that the portal vein and hepatic vein remain patent while the hepatic parenchymal tract is lined.
- MRI safety and scanning conditions should be confirmed in the current manufacturer labeling before imaging. The implant may be subject to specific field-strength, spatial-gradient and heating limits.
- TIPS may be unsuitable or require special evaluation in patients with severe liver failure, significant heart failure, uncontrolled infection, severe pulmonary hypertension or other contraindications to portosystemic shunting.
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.