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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 ?
510(k)
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.
FDA-Cleared Indications
- Creation of a transjugular intrahepatic portosystemic shunt to reduce portal hypertension.
- Treatment of complications associated with portal hypertension, including variceal bleeding.
Clinical Applications
- Creation of a shunt between the portal vein and hepatic vein through a transjugular approach.
- Reduction of portal venous pressure in patients with portal hypertension.
- Management of portal-hypertension complications when clinically indicated under the device labeling.
Reported off-label uses
- Treatment of refractory ascites in selected patients with portal hypertension.
- Management of hepatic hydrothorax related to portal hypertension in selected patients.
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 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.
Practical Considerations
- The device is used under fluoroscopic and contrast-imaging guidance, generally through venous access in the neck.
- Patient selection requires assessment of liver function, cardiac status, portal and hepatic vein anatomy, bleeding risk, and risk of hepatic encephalopathy.
- The record provided does not specify device diameters, lengths, delivery-system compatibility, or MRI labeling; these details should be confirmed in the manufacturer’s instructions for use.
- A TIPS can increase blood flow through the shunt and may worsen or precipitate hepatic encephalopathy or heart failure in susceptible patients.
- The procedure is typically performed with local anesthesia and moderate sedation or general anesthesia, depending on patient condition and institutional practice.
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.