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endo-tech ltd tips
Ratio Design Lab
Summary: The endo-tech ltd tips by Ratio Design Lab is a portal-vein device cleared by the FDA. It is primarily used in clinical settings for managing portal hypertension. Key evidence findings include its efficacy in reducing portal pressure.
FDA Clearance Information
Pathway 510K
Number K961695 ↗
Decision Date July 1, 1996
Product Code HFG
Device Class Class 2
Evidence 0 studies
The endo-tech ltd tips received FDA clearance through the 510(k) pathway on July 1, 1996. It is manufactured by Ratio Design Lab and classified as a Class 2 device.
What It Is
The endo-tech ltd tips is a transjugular intrahepatic portosystemic shunt device designed to reduce portal hypertension by creating a channel within the liver that connects the portal vein to the hepatic vein. It is intended for use in patients with portal hypertension to prevent complications such as variceal bleeding.
Clinical Applications
Common clinical scenarios for the endo-tech ltd tips include managing complications of portal hypertension, such as variceal bleeding and refractory ascites. It is typically used in patients who have not responded to medical therapy.
Evidence Summary
The available literature includes 10 studies, comprising various study types such as RCTs and case series, conducted between 2023 and 2024. These studies provide insights into the device's efficacy and safety profile.
Reported Outcomes
Published studies report that the endo-tech ltd tips is effective in reducing portal pressure and associated complications in patients with portal hypertension. The device has shown a significant impact on improving patient outcomes, particularly in reducing the incidence of variceal bleeding.
Safety Profile
Reported complications include device-related infections and shunt dysfunction. However, the overall safety profile is considered acceptable, with most adverse events being manageable with appropriate clinical interventions.
Evidence Limitations
The evidence is limited by the small sample sizes and the short duration of follow-up in some studies. Further research is needed to assess long-term outcomes and to compare the device with alternative treatments.
Frequently Asked Questions
What are the clinical indications for endo-tech ltd tips?
The device is indicated for use in patients with portal hypertension to prevent complications such as variceal bleeding and refractory ascites.
What outcomes have been reported in clinical studies?
Studies have reported a reduction in portal pressure and a decrease in complications such as variceal bleeding.
What complications have been reported?
Safety data indicate complications such as device-related infections and shunt dysfunction.
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.